vatsakadi madhumeha-kc

CLINICAL EVALUATION OF VATSAKADI QWATHA IN THE MANAGEMENT OF MADHUMEHA W.S.R TO

DIABETES MELLITUS (NIDDM)

BY

Dr. SRIKRISHNA H.A BAMS (RGUHS)

Dissertation submitted to the Rajiv Gandhi University of Health sciences, Karnataka, Bangalore

In partial fulfillment Of the requirements for the degree of

Ayurveda Vachaspati” M.D. [Ayurveda]

In KAYACHIKITSA

GUIDE Dr. SURESH R.D

M.D. (Ayu), MS (C&P), CYS.

DEPARTMENT OF POST GRADUATE STUDIES IN KAYACHIKITSA A.L.N.RAO MEMORIAL AYURVEDIC MEDICAL COLLEGE

KOPPA – 577126, CHIKMAGALUR DISTRICT KARNATAKA, INDIA NOVEMBER - 2010

I hereby declare that this dissertation entitled “Clinical Evaluation Of

Vatsakadi Qwatha In The Management Of Madhumeha W.S.R To Diabetes

Mellitus (NIDDM).” is a bonafide and genuine research work carried out by me

under the guidance of DR.SURESH.R.D. Department of Post Graduate Studies

in KAYACHIKITSA, A.L.N. Rao Memorial Ayurvedic Medical College P. G. Centre,

Koppa

Date:

Place: Koppa

Department of Post graduate Studies in KAYACHIKITSA

A.L.N.Rao Memorial Ayurvedic Medical College Koppa – 577126 Dist: Chikmagalur

Declaration

DR.SRIKRISHNA H.A P.G.SCHOLAR,

Dept. of Kayachikitsa A.L.N. Rao Memorial Ayurvedic Medical College, Koppa – 577 126

This is to certify that the dissertation entitled “Clinical Evaluation Of

Vatsakadi Qwatha In The Management Of Madhumeha W.S.R To Diabetes

Mellitus (NIDDM).” is a bonafide research work done by

DR. SRIKRISHNA H.A, in partial fulfillment of the requirement for the

degree of Ayurveda Vachaspati (MD) in KAYACHIKITSA of Rajiv Gandhi

University of Health Sciences, Bangalore, Karnataka.

Date:

Place: Koppa



Certificate

DR SURESH R.D M.D (Ayu), MS (C&P), CYS

GUIDE & ASSISTANT PROFESSOR Post graduate Department of Kayachikitsa

A.L.N. Rao Memorial Ayurvedic Medical College, Koppa – 577 126



This is to certify that the dissertation entitled “Clinical Evaluation Of Vatsakadi

Qwatha In The Management Of Madhumeha W.S.R To Diabetes Mellitus

(NIDDM).” is a bonafide research work done by DR. SRIKRISHNA H.A,

in partial fulfillment of the requirement for the degree of Ayurveda Vachaspati (MD)

in KAYACHIKITSA of Rajiv Gandhi University of Health Sciences, Bangalore,

Karnataka.

Date:

Place: Koppa



Certificate

DR. DEBAJIT BHATTACHARYA M.D. (Ayurveda)

H.O.D. & PROFESSOR Post Graduate Department of Kayachikitsa

A.L.N. Rao Memorial Ayurvedic Medical College, Koppa – 577 126

This is to certify that the dissertation entitled “Clinical Evaluation Of Vatsakadi

Qwatha In The Management Of Madhumeha W.S.R To Diabetes Mellitus

(NIDDM).” is a bonafide research work done by DR. SRIKRISHNA.H.A,

in partial fulfillment of the requirement for the degree of Ayurveda Vachaspati (MD)

in KAYACHIKITSA of Rajiv Gandhi University of Health Sciences, Bangalore,

Karnataka.

Date:

Place: Koppa

Prof. DR.SANJAYA.K.S. B Sc, MD (Ayurveda)

PRINCIPAL, A.L.N.Rao Memorial Ayurvedic Medical College,

Koppa –577126

Endorsement

COPYRIGHT

I hereby declare that the Rajiv Gandhi University of Health Sciences,

Karnataka shall have the rights to preserve, use and disseminate this dissertation in

print or electronic format for academic/research purpose.

Date:

Place: Koppa

© Rajiv Gandhi University of Health Sciences, Karnataka

DR.SRIKRISHNA.H.A P.G.Scholar,

Dept. of Kayachikitsa A.L.N. Rao Memorial Ayurvedic

Medical College, Koppa – 577 126

ACKNOWLEDGEMENT

Salutations and surrenderence of this whole work under the lotus feet of his highness and holiness Sri Sri Sri Rangapriya Mahadesikan and his highness and holiness Sri Sri Sri Swayamprakasha Sachidananda Saraswathi Mahaswamiji.

Salutations and surrenderence to the self within beloved parents, Sri.H.S.Ananthashayanam (Retired Manager, ING VYSYA BANK and Smt.M.S.Vedavalli (Retired Headmistress), innate selfmate Mr. Srinidhi H.A and sister-in-law Smt Dr Janaki, Sri Sitaram Bhat and Smt. Nagaratna and all my other family members whose constant blessings through true - love, support, sacrifice, encouragement and inspiration has sculptured this whole work towards its smooth and successful completion.

Salutations and surrenderence to the self within beloved great teachers Dr Rangapriya Mahadesikan, Dr.N. Shivarama Gayathri, Dr. Shobha. G. Hiremath, Dr Geetha Bhai, Dr Ahalya who taught and will be teaching the essential lessons of Ayurveda for lifetime.

Salutations and surrenderence to the self within beloved and respected Guide Dr. Suresh. R. D, M.D (Ayu), MS (C&P), CYS, P.G Dept. of Kayachikitsa, A. L. N. Rao Memorial Ayurvedic Medical College Koppa for his blessings through high esteemed standards of guidance, meticulous supervision, timely advices, motivation, inspiration and co-operation throughout the successful completion of this dissertation work.

Salutations and surrenderence to the self within beloved and respected Sri. Aroor Ramesh Rao, President, A.L.N. Rao Memorial Ayurvedic Medical College, Koppa for giving an opportunity to pursue post-graduate study in his esteemed and prestigious institution.

Salutations and surrenderence to the self within beloved and respected Dr.Sanjaya.K.S M.D (Ayu), Principal, A.L.N Rao Memorial Ayurvedic Medical College, Koppa for his immense help and support in completing this work.

Salutations and surrenderence to the self within beloved and respected Dr. Debajith Bhattacharya M.D (Ayu), HOD and Professor, P.G Department of Kayachikitsa and Prof. Dr P.K. Mishra M.D (Ayu),

Department of Kayachikitsa for their blessings through great hearty inspiration.

Salutations and surrenderence to the self within beloved and respected P.G staffs in the Dept. of Kayachikitsa; Dr.Prasanth G.S M.D

(Ayu),PhD, Dr.C.B.Singh M.D (Ayu), Dr. Rita Singh M.D (Ayu), Dr. Srinivas M.D (Ayu), Dr. Shobha Shetty M.D (Ayu), Dr.Niranjan, M.D (Ayu), Dr.Smitha Manoj M.D

(Ayu), Dr Usha Rani M.D (Ayu) Dr Triveni M.D (Ayu) and Dr. Shobha. R. Itnal M.D (Ayu).

Salutations and surrenderence to the self within beloved and respected Prof. T.K.Mohanta M.D, PhD (Ayu) and Prof. R.R. Mishra, M.D (Ayu), for their substratal constructive suggestions during the successful completion of this Dissertation work.

Salutations and surrenderence to the self within beloved and respected Prof. Dr D.K.Mishra M.D (Ayu), HOD of Bhaishajya Kalpana & Assistant Principal of P.G faculty and Prof. Dr Vidyasagar M.D (Ayu), HOD of Dravyaguna for their constant encouragement and valuable suggestions.

Salutations and surrenderence to the self within beloved and respected Dr. Prashanth Kumar Jha DIM, CIPR, PGDEE, MSc, Ph.D. Head, Quality Control Laboratories, for his guidance and support for Phyto Chemical Analysis without which the study would have been incomplete.

Salutations and surrenderence to the self within beloved and respected Prof. Dr H.R.Pradeep M.D (Ayu) Assistant Principal of U.G faculty and other P.G. faculty of Dravyaguna Department; Dr.Ilanchezhian M.D (Ayu), Dr.Harivenkatesh M.D (Ayu), Dr Vinayak Bhat M.D (Ayu) and Dr.Bhanu M.D (Ayu) for their extensive help in the drug review.

Salutations and surrenderence to the self within beloved and respected Dr.Mathapati M.D (Ayu), Dr. Milind Hukkeri M.D (Ayu), Dr. Roshy M.D (Ayu), Dr. Harikrishnan M.D (Ayu), Dr. Abdul Kareem M.D (Ayu), Dr. Shubha Shastry M.D (Ayu) and Dr. Sandeep Sarode M.D (Ayu), Department of Bhaishajya Kalpana for their guidance in the preparation of medicine.

Salutations and surrenderence to the self within beloved and respected Dr. Suryakumar, M.D (Ayu), Dr Basavaraj M.D (Ayu), Dr Vidyavati M.D (Ayu) from the Department of Shalakya Tantra, Dr. Laxmikanth M.D

(Ayu), Dr. Vikram M.D (Ayu), Dr. Mithun M.D (Ayu) and Dr. Satish M.D (Ayu), from the Department of Shalaya Tantra for their support in the dissertation work.

Salutations and surrenderence to the self within beloved and respected Dr. Suhas Shetty, M.D (Ayu), for his kind inspirational attitude and meticulous guidance in statistical work.

Salutations and surrenderence to the self within beloved and respected Dr. Ram Mohan, and Dr. Shanbhag, Consultant Physicians of this bonafide Ayurvedic college and hospital for their support during various stages of this work.

Salutations and surrenderence to the self within Dr. Sandhya, M.D (Ayu), Dr. Elizabath, M.D (Ayu), Dr. Sonmankar, M.D (Ayu), Dr. Basavaraj, M.D (Ayu), Dr. Moharar M.D (Ayu), Dr. Rashmi Sharma M.D (Ayu), Dr. Saraganachary M.D (Ayu) and Dr. Prashanth.K M.D (Ayu), for their moral support during the study tenure.

Salutations and surrenderence to the self within the treasurest, the sweetest reminiscences of loving and affectionate sharing and caring attitude shown by our dear seniors Dr. Nagendra M.D (Ayu), Dr. Sreejith M.D (Ayu), by dear loving batchmates Dr. Bejoy, Dr. Lovelin eralil, Dr. Krishnaveni, Dr. Thulya, Dr. Sriparvathi, Dr. Deepa, Dr. Ananda Bhairavi, Dr. Pallavi, Dr. Katyayani, Dr. Kiran, Dr. Jagadish Mayya, Dr. Narappa Reddy, Dr Vaishnavi, by dear loving juniors Dr. Suresh, Dr. Sudev, Dr. Subin, Dr. Jayakrishnan, Dr. Neelakantan, Dr. Divya Khare, Dr. Dhanyamurali, Dr. Soumit kumar, Dr. Parag, Dr. Kanchan kulkarani whose warmth hearty and intellectual memories will always be cherished as the ei-force, besides just being the e & i forces for the successful completion of this work.

Salutations and surrenderence to the self within all the patients who were included and excluded during the study for being the primordial ei-force for the present and the future endeavours.

Salutations and surrenderence to the self within all the hospital staff, pharmacy staff and especially for Ms. Amrutha and Mr. Mohana, the Lab technicians for their immense hearty and intellectual support for the successful completion of this work.

Koppa, Nov. 2010. Dr. Srikrishna.H.A

ABSTRACT

Madhumeha is a term considered for the condition of all types of Prameha and

specifically for one among the Vatika Prameha as elucidated by Acharya Chakrapani

in Charaka Samhita and is characterized by Prabhuta and Avila Mutrata as the

Samanya Lakshana. With specific Madhumeha lakshanas, some Ayurvedic scholars

correlate Madhumeha with Diabetes Mellitus, which is a metabolic disorder

characterized by hyperglycemia with or without Glycosuria resulting from an absolute

or conditional deficiency of insulin. Madhumeha which has been correlated with

Diabetes Mellitus has become a global health threat inspite of advances in

conventional science; while, India has been projected by W.H.O as the country with

the fastest growing population of Diabetic patients. Recent studies have estimated that

in the year 2000, 171 million people had diabetes and are expected to double by

20301. So, in an attempt for early diagnosis and to combat this disease condition

effectively; a formulation, Vatsakadi Qwatha mentioned in Sharangadhara Samhitha,

Qwatha Kalpana Adhyaya in the context of Mehagna qwatha, has been selected for

the present study based on the hypothesis that the drugs like Vatsaka, Triphala,

Daruharidra, Musta and Bijaka having Tikta Kashaya as the Pradhana Rasa and

Mehagna property are potent enough to combat this disease condition and are also

easily available.

OBJECTIVES:

• To evaluate the efficacy of the formulation, Vatsakadi Qwatha in the management of

Madhumeha w.s.r to Diabetes Mellitus (NIDDM).

• To assess the merits and demerits of the trial drug, Vatsakadi Qwatha.

• Detailed study of the disease covering classical and modern literatures.

• To evaluate the Diabetic Quality of life.

METHODS:

Cases presenting with classical sign and symptom of Madhumeha were

selected. The preparation Vatsakadi Qwatha had been given to a group of 20 patients.

The symptoms of Madhumeha like Prabhutamutrata, Avilamutrata, Pipasa, Kshudha

etc had been assessed before and after the treatment. The duration of the study was 45

days with 90 days follow up study with assessment of results at the interval of 15

days.

RESULTS:

The drug Vatsakadi Qwatha showed significant results in combating the

symptoms of the disease Madhumeha during treatment period. The follow up results

were insignificant.

CONCLUSION:

The Polyherbal formulation Vatsakadi Qwatha was effective in the

management of Madhumeha during treatment period and was not effective enough

during the follow up period. The ingredients of the formulation are easily available;

needs constant discrete observation over the subject by the treating physician and has

a wide scope for further studies.

KEYWORDS:

Madhumeha, Diabetes Mellitus, Vatsakadi Qwatha.

CONTENTS SL. NO. TOPIC PAGE

1. Chapter- I INTRODUCTION 1

2. Chapter- II OBJECTIVES 4

3. Chapter- III REVIEW OF LITERATURE

a) HISTORICAL REVIEW 5

b) DISEASE REVIEW 11

c) DRUG REVIEW 90

4. Chapter- IV METHODOLOGY

a) MATERIALS & METHODS 99

b) OBSERVATIONS 110

5. Chapter- V RESULTS 128

6. Chapter- VI DISCUSSION 139

7. Chapter- VII CONCLUSION 164

8. Chapter- VIII SUMMARY 166

9. REFERENCE

10. BIBLIOGRAPHY

11. ANNEXURE

ABBREVIATIONS

1. A.Hr Ashtangahrudayam

2. A.Sa Ashtangasangraham

3. Cha.Sam CharakaSamhitha

4. Su.Sam Susrutha Samhita

5. Ma.Ni Madhava Nidanam

6. Sha.Sam Sharangadhara Samhitha

7. Ka.Sam Kashyapa Samhitha

8. Ha.Sam Harita Samhitha

9. Bha.Pra Bhavaprakasam

10. Y.R Yogaratnakaram

11. H.P.I.M Harrisson’s Principles of Internal Medicine

12. D.P.P.M Davidson’s Principles and Practice of Medicine

13. Ni Nidanasthanam

14. Chi Chikitsasthanam

15. In. Indriyasthanam

16. Vi Vimanasthanam

17. U. Utharardham

18. R.V Rig-Veda

19. S.B Shayana Bhashya

20. C.D Chakradutta

21. R.P Robbins-Pathology

22. K.V.K.C.M Clinical Medicine - K.V.Krishnadas

23. Chak Chakrapani

24. Ni.Sam Nibandha Sangraha

Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)

INTRODUCTION

|| िन या: ूाणभतृां देहे वात प कफा य: । वकृताः ूकृितःथा वा तान बुभु सेत प डतः ॥् - च.सू.१८/४८

In an attempt to dig out the secrets of healing within the asylum of diseases;

the therapeutic pearls of wisdom in the form of aphorisms delivered by our Ancient

Ayurvedic Seers several thousand decades ago is now still on the verge of great

discoveries and achievements, under the sacred healing hands of the present day

Ayurvedic Professionals of varied specialties.

The Prime Eternal Objective Instinct of these professionals being the Quest Of

three fundamental humors in relationship with the elan vital governing both Healthy

and Non-Healthy state of the Human Body, Mind and Soul, thus guiding them to the

greatest heights of professional success by fulfilling the four essential pursuits of life1.

Thus, literally, the word Ayurveda cannot be restricted to be defined as only –

Science of Life but, it would be wise enough to be extended as the Most Scientific

Eternal Divine Coded Medical Language which teaches the value of being healthy

and the means to achieve it through our day to day activities of life.

This is achieved by the Ayurvedic professionals with the help of the four

essential limbs of therapeutics like the Bhishak, Dravya, Upastha and Rogi

respectively, termed as Bhishak Chatushpada by the ancient seers.

‐

The present 21stcentury is gradually and drastically changing the attitude of

every individuals of the society towards every aspect of life by guiding and prompting

them towards a weird quality of day to day physical and mental activities and finally

making them to lead an obsessive, erratic lifestyle which in turn has led to an health

crisis of various lifestyle disorders. One among those lifestyle disorders is

Madhumeha vis a vis Diabetes Mellitus, which is now becoming a major health threat

in both developed and developing countries. Statistically, India is now considered as

1 -


the diabetic capital and is sure to double from the 2010 - 171 million diabetics by

2030.

Acharya Charaka has quoted “as the birds are attracted towards the tree

where their nests lies, similarly Madhumeha affects people who are voracious eaters

and have aversion to physical exercise. The disease Madhumeha, its definition,

etiology, clinical features and principles of treatment appear to be similar with the

disease “Diabetes Mellitus”, which is considered as “Ice Berg” disease in the present

era1.

Our classics have termed Madhumeha1 as Asadya keeping in terms of Vataja

Prameha and also as a Kulaja Vikara - Jataja but, the term here in the present study is

taken in accordance to the opinion of Acharya Chakrapani where Meha Samuha can

also be termed as Madhumeha and by the timely intervention with appropriate

Oushadha, Pathya and Vyayama for the same both the short-term and long-term

complications can be effectively managed and prevented by breaking the vicious

cycle of pathology and thereby enhance the Quality Of Life of the patient. If it is not

done so; then, the disease pathology progresses enough to gain a strong chronicity and

becomes Asadya.

Ayurveda proposes number of Herbal and Herbo-mineral formulations for the

management of Madhumeha. Here a sincere attempt has been made to provide a

better management of this dreadly condition, Madhumeha. The present research work

undertaken is entitled as “Clinical Evaluation of Vatsakadi Qwatha in the

Management of Madhumeha With Special Reference to Diabetes Mellitus” based

on the hypothesis that the formulation Vatsakadi Qwatha11 mentioned in

Sharangadhara Samhita, Madhyama khanda, 2nd Chapter- Qwatha Kalpana Adhyaya-

Mehagna context, with its ingredients Vatsaka1, Haritaki, Amalaki, Vibhitaki,

‐ 2 -


Daruharidra, Musta and Bijaka have Tikta Kashaya Rasa Pradhanata and

Mehagna property.

The present work also includes theoretical aspects of Madhumeha, brief

historical review, Nirukti and Paribhasha, Nidana Panchaka, Bheda, Sapeksha Nidana,

Chikitsa, Upadrava, Sadhya Asadhyatha as explained by different Ayurvedic classics

and also its modern parlance.

Random selection of patients for clinical study, case study, adopted treatment

and its methods with respective subjective and objective parameters, results

discussion and conclusion are dealt at the end in detail.

Thus the entire work has been strategized chapter wise in the following

manner:

Chapter I Introduction

Chapter II Objectives

Chapter III Review of literature

Chapter IV Methodology

Chapter V Observation

Chapter VI Results

Chapter VII Discussion

Chapter VIII Conclusion

Chapter IX Summary

Bibliography

Annexure

‐ 3 -


OBJECTIVES

The study is based on the following aims and objectives.

1) To assess the efficacy of ‘Vatsakadi Qwatha’ in the management of Madhumeha.

2) To assess the merits and demerits of the drug.

3) Detailed study of the disease covering classical and modern literature.

4) To evaluate the Diabetic Quality Of Life.

HYPOTHESIS

1. Null Hypothesis:

Vatsakadi Qwatha does not have any effect in the management of patients suffering

from Madhumeha.

2. Alternative Hypothesis:

Vatsakadi Qwatha do have effective role in the management of patients suffering

from Madhumeha.

‐ 4 ‐


HISTORICAL GLIMPSES

Study of sequential evolution of an event forms the fremost step in the field of

research. Study of history is of great important to know about the systematic development and

progress of the subject to determine the future plans for further establishment and research

designing. History of Medicine starts from the very moment when the human beings came

into existence. Among the various ancient treatises, Ayurveda provides an extensive and

emeritus description of diseases and their treatment. Here an attempt to review all the

Ayurvedic and Modern Treatises providing information related to historical background of

Madhumeha has been made.

The evolution of Madhumeha can be traced right back from Vedas but, in

rudimentary form. When we go through the Atharvaveda there is a reference related to the

disease 'Asrava' along with its management. Sayana Acharya in his Sayana Bhashya reveals

that Asrava means 'Mutraatisara,' the English translator Whitney (1962) interpreted it as flux

and Griffith (1962) as morbid flow, while leeman has translated the meaning of Asrava as

Diabetes Mellitus. Sayanacharya has highlighted the vatic nature of this ailment.

(A) Samhita Period:

Elaborative description of the disease Meha viz-a-viz Prameha- Madhumeha has been

found during Samhita period.

(1) Charaka Samhita: Ref Cha. Ni. 4, Cha. Chi. 6

In this ancient treatise of medical science, Charaka has explained the Etiology,

Pathogenesis, Prodromal Symptoms, Clinical Features, expected Complications and

descriptive therapeutic procedures with discretion – Sutra Sthana 17th chapter, Nidana Sthana

4th chapter, Chikitsa Stana 6th chapter.

-5-


(2) Sushruta Samhita: Ref. Su. Ni. 6, Su. Ni. 11, 12,13.

Acharya Sushruta has contributed that the disease Prameha which when not treated at

appropriate time gets transformed into Madhumeha in Nidana Sthana – 6th chapter, the whole

disease and its therapeutic purview in Prameha – Pramehapidaka – Madhumeha in Chikitsa

Sthana – 11th, 12th, 13th chapters successively. The distinct feature is the usage of Ksaudra

Meha' instead of Madhu Meha in vatic variety in Nidana Sthana 6th chapter, Specific

decoctions for specific type Prameha and mentioned the Specific Dietary Pattern which

should be avoided and to be used accordingly in Chikitsa Sthana.

(3) Vagbhata Samhita: Ref. A.Hr. ni.10,

A.Hr.12

Vagbhata has mentioned 2-3 types of underlying cause leading to Madhumeha i.e.

Dhatukshaya and Avrutapatha or even both and added Sveda as one among the Dushya in

Nidana Sthana 10th chapter.

(4) Harita Samhita: Ref Ha.Sam. II sthana 1/9

Acharya Harita has mentioned the cause as Papajanya and enumerated 13 types of

Prameha with nomenclature different than above treatise like, Puyameha, Ghrutameha etc.

(5) Bhela Samhita:

He described Prameha is of two type i.e. Svayamkruta and Prakruta Meha.

(6) Kashyapa Samhita:

He has mentioned the symptoms of juvenile diabetes clinical findings in Vedana

Adhyaya and noted the disease as Chirakari.

-6-


(B) MEDIEVAL PERIOD:

In this period commentaries mainly written, but most of them content only the

collection of thoughts from previous authors.

(1) Madhavanidana: Ref. Ma. Ni. 33

He collectively repeated the description of Charaka, Susruta and Vagbhata.

(2) Gayadasa: Ref. Nyaya Chandrika Su. Ni.6/6

He has explained that the Samalatva of the Mutra is due to the presence of Dusya in

Mutra.

(3) Sharangadhara Samhita: Ref. Sha. Ma.11

He has mentioned the 20 types of Prameha in Prathama Khanda 7th chapter, while we

find various scattered references with respect to the disease and the respective formulations

for the latter in different forms. The Polyherbal formulation for the present study has been

selected from Qwatha Kalpana Adhyaya of the present treatise mentioned in Madhyama

Khanda. Meha Prakarana.

(4) Bhavaprakasa: Ref Bha. Ni. Ma. Kha. 38

He describes Prameha and Madhumeha along with some new Herbo-Mineral

preparations.

(5) Yogaratnakar:

He has explained Prameha and Madhumeha along with its respective treatment.

-7-


MODERN REVOLUTION AND THERAPEUTIC LANDMARKS:

Some of emeritus inventive landmark about the Diabetes Mellitus:

(1) Areatus (Christian era) : Firstly he mentioned the disease as Diabetes.

(2) William Cullen - 1709 A.D : Added suffix mellitus to the diabetes.

(3) Mathew Dobson L-1775 A.D : Found that sweetness of urine is due to sugar.

(4) Thomas Cowley -1781 AD : Pancreas as the possible cause of the disease.

(5) Paul Langerhans -1869 AD : Group of cells in Pancreas.

(6) Gusteve Edward -1893 AD : Group of cells as Islets of Langerhans.

(7) Opie -1901 AD : Hypothesis- Islets Of Langerhans dysfunction.

(8) Babting and Charles -1922 AD : Discovered Insulin.

-8-


NIRUKTHI AND PARIBHASHA

In Ayurveda, Madhumeha is a term used for all the 20 types of Prameha and

also as a sub type of Vatika Prameha which is Asadya. In this present study since

Madhumeha is taken in terms of Meha Samuha but not restricted to the terms of

Vatika Prameha hence understanding its literal Derivation is quite important for

proper understanding of the intricacies in the usage of the term Madhumeha1.

ETYMOLOGY:

Meha: The word Meha is derived from the root ‘Mih Sechane’ by adding 'lyu’

Pratyaya to it, gives the meaning watering. - Shabda Kalpadruma.

� Mehayati Sinchati Mutraretamsi iti mehaha� - Halayudha Kosha

� Mehayati mutrayati iti arthaha� - Su. Ni. 9/10

This term is suppose to be used for all types of Meha either it is Prameha or

Madhumeha- according to Acharya Chakrapani.

The first and the foremost Vedic reference for the word Meha is found in the

Yakshma Nashana Suktha – 5th Verse, 163rd Suktha of 10th Mandala of Rigveda.

Shayana Bhashya21 interpretes the word Mehana as Medr, which means Shishnya i.e.

Penis on the above mentioned reference.

1. Prameha1 - The word 'Prameha' is composed of two sub-words. i.e.

Pra + Meha

According to the the above verses, it means to excrete urine and semen profusely.

In Sanskrit literatures, the word 'Mih' is used to denote - to make water, to wet,

to ejaculate semen. When the prefix “Pra” is added to the root word 'Mih', the word

becomes Prameha. ‘Pra’ suggests excess or profuse in both Frequency and Quantity.

-9-


So, the word Prameha can be understood as increase in both frequency and quantity of

urine.

“Prakarshena Mehayati Yasmin Roge” - Su. Ni. 6/10

This derivation of word is again substantiated with the Common Clinical

Features of Prameha described as Prabhutamutrata and Avilamutrata. Su.ni.6/6,

A.Hr.ni.10/7.

2. Madhumeha: - The word Madhumeha is derived from two words Madhu and

Meha.

The word Madhu is derived from the root “Manyante Viseshena Jananti Janah

Yasmin”. In Sanskrit literature Madhu word is used with various synonyms in various

contexts like Kshaudram, Kusumasavam, Madhyama, Makarandah, Makshikam,

Madhura Rasa, Jalam, Pushparasa, Kshiram etc - Arunadutta

So, Madhumeha is a disease in which the excretion of urine possesses the quality

similar to that of Madhu (honey) in its colour, taste, smell and consistency. -

Madhavakara.

It means ‘Madhumeha’ is a disease in which a patient passes sweet urine and

exhibits sweetness all over the body i.e in sweat, mucus, breath and blood etc.

PARIBHASHA OF MADHUMEHA:

With the above literary background for the term “Madhumeha”, it can be

defined as a clinical entity in which subject passes large quantity of urine with

Kashaya, Madhura rasa and Ruksha quality similar to the characteristics of honey and

thus body attains sweetness – Acharaya Charaka and Vagbhata.

-10-


Acharya Sushruta has narrated the term “Kshaudrameha” in place of

Madhumeha .The “Kshaudra” is one of the varieties of Madhu which is Kapila

(tawny) in colour and hence considered as a synonym to the word Madhu as well. So,

it is clear that Kshaudrameha resembles Madhumeha. As per Sushruta all the varieties

of Prameha; if neglected, get transformed into the pathological streak of Madhumeha.

SYNONYMS:

Few of the synonyms of Madhumeha mentioned in the ancient classics are

follows:

OJOMEHA: This is one among the four sub-types of Vataja Prameha.

Vitiated Vata dosha causes diminution of Ojas through which, the urine along with

the change in its taste and texture finally results in Ojomeha.

KSHAUDRAMEHA: This term has been used by Sushruta because of its

close resemblance with Madhu – Acharya Sushruta.

PAUSHPAMEHA: In Anjana Nidana, the word Paushpameha has been used

in place of Madhumeha. In Sanskrit literature, Paushpameha means Madhu.

ETYMOLOGY OF DIABETES MELLITUS

The word diabetes is originated from the French word named “Jiyabatis” which

means punctured pitcher or pitcher with leak, so that water sprinkles out of it.Diabetes

– Parashuram Shastry.

The word diabtes mellitus contains two words i.e diabetes and mellitus. In Greek

Diabetes means to run through a siphon and the term Mellitus means honey.

WHO APPROVED DEFINITION OF DIABETES MELLITUS:

-11-


Diabetes Mellitus is a group of metabolic disorders characterized by chronic

hyperglycemia associated with disturbances of carbohydrates, fat and protein

metabolism due to absolute or relative deficiency in insulin secretion and /or action23.

SYNROME X or METABOLIC SYNDROME is a cluster of cardiovascular risk

factors that frequently coincides with insulin resistance and hyperglycemia. The

metabolic syndrome is a common condition, associated with genetic predisposition,

sedentary lifestyle, obesity, and aging23.

-12-


NIDANA

Nidana is the specific core pre-disposing factor of a disease. The cycle of

pathology and severity of the disease considerably revolves around the type and

severity of the predisposing factors in relation to the tridosha respectively.

Ayurvedic classics elaborately describes about the general etiological factors

of Prameha at the same time it is the highness of discretion elucidated by Acharya

Charaka in relation to this disease which even though is Tridosha in origin but it is

influenced by specific doshic etiologies which inturn decides the extent and strength

of the corresponding disease pathology leading to Madhumeha latter –Vikara Vighata

Bhava Abhava Prativishesha. Hence, classical etiologies mentioned for Prameha can

be taken for Madhumeha also. Etiological factors of Prameha can be classified into

Sahaja and Apathyanimittaja.

I. Sahaja Prameha: Sahaja Prameha is further divided in to Kulaja and

Garbhaja.

A. Kulaja Prameha:

It is due to defects in Stri & Pumbeeja (Ovum & Sperm) which is said to be Matru-

Pitrukrita Beejadosha finally resulting in Sahaja Prameha. This Beeja Dosha

highlights the relevance of Kulanupatini Prakruti and may have its origin from parents

of both father and mother i.e. it may be inherited from generation to generation and

thus it is a unique example of hereditary disease.

B. Garbhaja Prameha:

Acharya Charaka opines that indiscrete excessive indulgence of Madhura Rasa

by garbhini is the chief cause for the changes and damages in the foetus. Over

indulgence in Madhura Rasa by mother during pregnancy is likely to induce Prameha.

-13-


Regarding Sahaja Prameha, genetic predisposition occurring in diabetes has

been well established based on various genome studies in conventional science. Study

focus is mainly on β-cells of islets of langerhans and the blood vessels.

Simultaneously, the metabolic functions leading to the rapid conversion of glucose

into fatty acid forming the adipose tissue have been suspected to have genetic origin.

These variations are due to variation of structure and function of chromosomes. Even

after having genetic predisposition; the stage of overt diabetes may take time to

precipitate – highlighting the concept of Lakshya Nimita1.

Hypothetically, indiscrete excessive intake of Madhura Rasa bring about

changes at the level of gene and thus provide a genetic pre-disposing condition in the

subject and again intake of excessive Madhura Rasa by the pre-diabetic subject in his

early life also precipitates Prameha. Thus; Beeja Dosha and Apathya, both play a

combined role in the causation of Sahaja Prameha.

II. Apathyanimittaja Prameha: Various opinions regarding the discription of

Apathyanimittaja Prameha by different Acharyas are described as follows,

Charakoktha Apathyanimittaja Prameha Nidana:

Asyasukham: Sedentory Sexual Habits and Sedentary Sitting Habits.

Swapnasukham: Sedentary sleeping habits.

Excessive indulgence in Dadhini: Curd and its various preparations.

Gramya, Audaka, Anupa Mamsa: Meat of domestic, aquatic, wet land animals.

Payamsi: Excessive use of milk and its preparations

Nava Annapanam: Excessive use of new grains and drinks.

Guda Vaikrutam: Jaggery and its various preparations.

Along with the above etiological factors, all regimens which vitiate Kapha

dosha should also be considered as the cause for Prameha.

-14-


Dravya Properties Dosha Prabhava Koolachara (living at river

side) Eg. Gaja, Gavaya, etc.

Madhura Rasa & Vipaka

Sheeta Veerya, Snigdha Guna

Mutrala & Kapha

Vardhak

Plava (Birds which swim)

Eg. Hamsa, Kroucha etc.

Sheeta Veerya, Snigdha Guna,

Madhura Rasa and vipaka

Mutrala & Kapha

Vardhaka

Koshastha (Live in burrows)

Eg. Shanka, Shukti etc.

Madhura Rasa & Vipaka,

Sheeta Veerya Snigdha Guna

Kapha Vardhaka

Padina (which have limbs)

Eg. Koorma etc.

Balya Mutrala

Matsya Nadeya

(Fishes of river)

Madhura Rasa, Snigdha and

Guru Guna

Shleshma

Samudra (Fishes of sea)

Eg. Timingala, Kulisha etc.

Guru, Snigdha, Ushna, guna, Madhura Rasa, and Vipaka

Shleshma

CHART: GRAMYA, OUDAKA AND ANUPA MAMSA RASA

Sushrutoktha Apathyanimittaja Prameha Nidana:

Acharya Sushruta opines in terms of Snigdha (unctuous), Medya (fatty) and

Drava (liquid) type of food as the causative factors.

Vagbhatoktha Apathyanimittaja Prameha Nidana:

Acharya Vagbhata opines in terms of Madhura, Amla, Lavana Rasa

predominant diet and sedentary habits which increase Medas, Mutra and Kapha as the

causative factors.

DOSHANUSAARA NIDANA VISHESHA:

Kaphaja Prameha Nidana

The following are the etiological factors which help in the immediate

manifestation of Prameha due to Kapha dosha - Frequent and excessive intake of

fresh corns like Hayanaka, Yavaka, Chinaka, Uddalaka, Naishadha, Itkata,

-15-


Mukundaka, Mahavrihi, Pramodaka and Sugandhaka; Intake of Pulses like fresh

Harenu and Masha with ghee; Intake of the meat of domestic, marshy and aquatic

animals; Intake of vegetables, Tila, Palala, Pishtanna, Payasa (a type of sweet

preparation), Krishara, Vilepi and preparations of sugarcane; Intake of milk, fresh

wine, Immature curd and its preparations; Avoidance of unction and physical

exercise; Resorting to inappropriate sleeping habit and sedentary habits; Resorting to

such regimens which produce more of Kapha, fat and urine.

Pittaja Prameha Nidana

Intake of Ushna, Amla, Lavana, Kshara and Katura Dravyas; Intake of food

before the digestion of the previous meal; Exposure to excessively hot sun, heat of

the fire, physical exertion and anger; Intake of mutually contradictory food articles.

Vataja Prameha Nidana

Excessive intake of Dravyas having predominantly Kashaya, Katu, Tikta Rasa,

Ruksha, Laghu and Sheeta Veerya; Excessive indulgence in sex and physical

exercise; Excessive administration of Vamana, Virechana, Asthapana and

Shirovirechana; Resorting to suppression of the manifested urges, fasting, assault,

exposure to sun, anxiety, grief, excessive blood letting, keeping awake at night and

irregular postures of the body.

Specific Etiology of Madhumeha:

The person indulging in food substances having Guru, Snigdha qualities and

excessive indulgence of Amla and Lavana Rasa substances and Navannapana,

excessive sleep, sitting in a same place for longer duration, avoiding exercises –

physical and mental exercises and also not resorting to the Shodhana process at proper

time or even resorting to the latter at improper time.

-16-


Acharya Sushruta has narrated that untreated Prameha in its initial stage, gets

converted into Madhumeha and becomes incurable.

According to Acharya Vagbhata, the urine of Madhumehi will be simulating

with that of Madhu. Two type of Vata vitiation has been mentioned, one is due to

Dhatukshaya and second due to Margavarana.

According to Acharya bhela, this disease is of two types based on the specific

etiologies like

1) Prakruthi Prabhaavam

2) Narasya Swakrutham

Etiopathogenesis according to modern medicine:

The etiology of Diabetes mellitus has yet to be understood in spite of the

advances made in the knowledge obtained with respect to various factors associated

with the causation of Diabetes mellitus. Based on the etiological factors Diabetes

mellitus can be classified into two main types namely,

1. Primary or Idiopathic Diabetes: Which is further subclassified into

Type I Diabetes or IDDM and Type II Diabetes or NIDDM.

2. Secondary Diabetes Mellitus.

Causes for Primary Diabetes Mellitus:

A. Genetic Factors:

a) Genetic susceptibility in IDDM:

IDDM is a heterogenous disorder in wich several factors may play a role.

IDDM tends to be a familial disorder and there is a 25-fold increase in the risk

amongst the siblings than the general population. Its inheritance is strongly related to

HLA loci on chromosome-6. It is seen that HLA B8, B15, B6, B21, BW3, DR3 and

DR4 are associated with a higher risk of diabetes. In Indians and Japanese IDDM

-17-


appears to be associated more with HLABW21 and BW54. Among identical twins

only 50% shows concordance for IDDM as against 100% for NIDDM.

b) Genetic Susceptibility in NIDDM:

Role of genetic factors in etiology of NIDDM has been appreciated ever since

the recognition of the disease, but the pathogenesis is less well understood. The

disease is not linked to any HLA genes as in Type I Diabetes. Though NIDDM occurs

in families, modes of inheritance are not known except for the variant termed

Maturity Onset Diabetes of the Young (MODY), which is due to three different gene

mutations. MODY 1 gene is located on the long arm of chromosome 20 and that for

MODY 3 is on the long arm of chromosome 12 while that of MODY 2 is due to

mutation of glucokinase gene located on the short arm of chromosome 7. It is highly

likely that ordinary NIDDM is polygenic.

B.Immunological Factors (Auto immunity):

The pathogenesis of Diabetes Mellitus mainly depends on the factors insulin

and its source, the β-cells. There is no evidence that Auto-immune mechanisms are

involved in the manifestation of Type II Diabetes (NIDDM) where as IDDM is a

slowly progressive T-cell mediated Auto-Immune disease. Hyperglyceamia

accompanied by the classical symptom of Diabetes occurs only when 70-90% of β-

cells have been destroyed. Islet cell antibodies can be detected before the clinical

development of type-1 Diabetes and disappear with increasing duration of diabetes.

Presently these antibodies are neither used for screening nor for diagnostic purposes,

but glutamic acid decarboxylase(GAD) antibodies may have a role in identifying late-

onset type-1 Diabetes in middle-aged people(Latent Autoimmune Diabetes in Adults-

LADA).

-18-


Although; recent studies reveal that approximately 10% of IDDM patients also

suffer from other Organo-Specific Autoimmune Disorders like Graves’s disease,

Addisions disease, Thyroiditis or Pernicious Anemia, there appears to be a broad

spectrum derangement of immunoregulation in these patients. By the time Overt

Diabetes develops, most of the insulin producing cells of the pancreas - β-cells will be

destroyed completely or will have disappeared.completely.

C. Environmental Factors:

The environment insult or factors may be the cause for manifestation of

Diabetes Mellitus. In many cases the environmental factor is believed to be a viral

infection of the beta cell. Epidemiological studies have linked viral infection with

IDDM. A viral etiology was originally suggested by seasonal variations in the onset

of the disease and by what appeared to be more than a chance relationship between

the appearance of diabetes and preceding episodes of mumps, measles, and congenital

rubella, Coxsackie’s B virus, hepatitis, infectious mononucleosis. The isolation of a

Coxsackie’s virus B 4 from pancreas of a previously healthy boy who died after an

episode of Ketoacidosis and induction of diabetes in animals inoculated with isolated

virus, also suggests a viral etiology. Further the support for viral theory comes from

observations that about 1/5th individuals with congenital rubella develop IDDM.

Viruses may damage the beta cells by direct invasion or by triggering an auto immune

response. They may also persist with beta cells and cause long term interference with

metabolic and secretory functions. While viruses do not produce IDDM in all infected

individuals, it is tempting to speculate that in susceptible individuals these infective

agents trigger a host of immunological phenomena resulting in beta cell death. The

viral theory should be treated with considerable caution. Serologic studies seeking

-19-


evidence of recent viral infection in patients with new onset IDDM are in conclusive

at best.

D. Diet:

Circumstantial evidence supports the proposition that dietary factors may, at

least in certain circumstances, influence the development of Type I Diabetes. It has

been suggested that exposure to cow’s milk or milk products early in life predisposes

to autoimmune Diabetes. The proposed environmental trigger is Bovine Serum

Albumin, operating through the mechanism of molecular mimicry. In the initial study

diabetic subjects were found to have antibodies to bovine albumin and an antibody

subset specific for a 17 amino acid epitope showed to the strongest association with

the disease. Exposure to cow’s milk in presumed to induce an immune response to 17

amino acid fragment in some infants, and cross β cells expressing the P 69 antigen.

This hypothesis has not received wide support.

Various chemical agents like pentamidine, vacor (rodenticide) and various

Nitrosoamines found in smoke and curried meat have been proposed as potentially

diabetogenic factors.

E. Age:

It is also one of the important risk factor in manifestation of Type II Diabetes.

Type II Diabetes is principally a disease of the middle aged and elderly (>40yrs).

Recently age of onset of Type II Diabetes mellitus is decreasing and is seen in

children and adolescents (i.e. <25 years- MODY) 29

F. Obesity:

Particularly central obesity and a change to western style are inevitable

accompaniment of modernization and it is one of the leading causes for manifestation

of Diabetes Mellitus of Type II variety particularly in India. Obesity probably acts as

-20-


a Diabetogenic factor (through increasing resistance to the action of insulin) in those

genetically predisposed to develop Type II Diabetes.

G. Life Style:

The sedentary life style with diminished physical activity combined with

overeating and obesity is associated with development of Type II Diabetes Mellitus.

H. Stress:

Stress may be a possible link factor for Diabetes either through a direct effect

on the Neuro-endocrine system by stimulating the secretion of counter regulatory

hormones and possibly by modulating immune activity or indirectly through the cycle

of overeating and subsequent development of obesity that may be associated with

stress 25.

I. Malnutrition in utero:

It is proposed that malnutrition in utero may programme beta cell development

and metabolic function at a critical period, so predisposing to Type II Diabetes later in

life.

Causes for Secondary Diabetes Mellitus:

Pancreatic Disease:

Acute and Chronic pancreatitis, Post Pancreatectomy, congenital pancreatic

aplasia, pancreatic carcinoma, cystic fibrosis and Haemochromotosis are few of the

conditions which manifests Secondary Diabetes Mellitus.

Hormonal Abnormalities:

The hormones such as Growth Hormone, Glucocorticoids, Catecholamines,

Thyromine and Glucagon cause impaired Glucose Tolerance or even an overt

Diabetes, as they have insulin antagonistic effect. Conditions such as Acromegaly,

Cushing’s syndrome, and Phenochromocytoma can cause Diabetes, especially in

-21-


those persons who are prone. It may also arise due to therapeutic administration of

Steroidal Hormones. Stress hyperglycemia associated with severe burns, acute

myocardial infraction and other life threatening illness, is due to excessive release of

Glucagon and Catecholamines.

Drugs and Chemical induced Diabetes:

Drugs or Chemicals can either impair insulin action or damage the beta cells

causing decreasing in the insulin secretion. Drugs like pentamidine and vacor are beta

cytolytic, where as glucocorticoids and nicotinic acid increase the insulin resistance.

Insulin Receptor Abnormalities:

Rare conditions associated with mutation in the insulin receptor or the post

receptor pathway leads to manifestation of Diabetes mellitus. The individuals have

extreme degrees of insulin resistance and are associated with Acanthosis Nigrican’s,

polycystic ovaries and rarely virilization. Leprenchaunism could be fatal and patients

do not cross the infancy.

Genetic Disorders:

Many genetic syndromes are associated with Diabetes. Down’s syndrome,

Klinefelter’s syndrome, Turner’s syndrome and Wolfram’s syndrome are some

important ones.

Role of Endocrine Glands:

Pituitary Gland14: The pituitary hormones can influence the course of Diabetes

Mellitus. The growth Hormone of pituitary has the diabetogenic power.

Administration of hormone leads to hydropic changes in beta cells associated with an

early reversible phase of Diabetes followed later by an irreversible phase with

complete destruction of beta cells. Diabetes may be associated with Acromegaly.

-22-


Adrenal Gland14: Adrenalectomy will arrest or modify the progress of experimental

Diabetes. The onset of Addisson’s disease has an ameliorating effect on the human

variety. Adrenal Hyperplasia or tumors may be associated with Diabetes.

Gestational Diabetes: Gestational Diabetes is defined as any degree of glucose

intolerance with onset or first recognition during pregnancy. During normal

pregnancy, insulin sensitivity is reduced through the action of placental hormones and

this affects the glucose tolerance. The insulin secreting cells of the pancreatic islets

may be unable to meet this increased demand in women genetically predisposed to

develop Diabetes. Repeated pregnancy may increase the likelihood of developing

irreversible Diabetes, particularly in obese women. However the patient should be

evaluated after six weeks after delivery and reclassified as either diabetic or non

diabetic.

Nidana similarities of modern view with ayurveda:

The atiological factors mentioned by modern medicine are also in concordance

with ayurvedic scholars. Both systems agree regarding genetic elements associated

with DM. According to modern view and ayurvedic view sedentary life habits play an

important role. Both systems deal with Medo Dhatudushti Nidana as a cause for DM.

-23-


Table No: 1 Similarities of Nidana in Modern and Ayurveda

MODERN VIEW AYURVEDIC VIEW

Genetic susceptibility is identified. One variety of prameha is Sahaja due to

Sukra and Artava Dosha.

Sedentory life habits are a prime

cause.

Ayurveda also mentioning the same like

Asyasukham, Swapna Sukham etc.

Diabetis has been discribed as

complication of Obesity due to insulin

resistance caused by fat globules.

Charaka also describes Prameha as a

Complication of Sthoulya.

Dietary factors influence development

of type1 DM.Some Diabetogenic

factors like bovine serum albumin

found in cow’s milk, nitrosamines

present in smoked and cured meat has

been identified.

Indiscrete use of Cows milk, Gramya

Mamsa, Anoopa Mamsa are considered

as major Nidana for Prameha by Charaka.

Mental factors like stress have been

accepted as a principal atiology.

Acharya Charaka explains as Krodha is a

predisposing factor for Pitha Prameha and

mental strain like Udvega and Soka will

cause Vataja Prameha.

Environmental factors enhance viral

infections and leads to diabetes have

been described.

Excessive Vata Pita Prakopa

environments like Atapa Sevana, Agni

Santapa etc have been described.

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PURVARUPA

Purvarupa are the most valuable prodromal signs and symptoms that signal the

forth-coming disease. Every disease has its own characteristic Purvarupa and become

manifested at the stage of Sthanasamshraya and it is one kind of warning signal to the

subject to restrain from those activities which triggers Prameha. As Madhumeha is

classified under the Vatika type of Prameha, Purvarupa of Prameha can be taken as

Purvarupa of Madhumeha1.

Table No 3. Purvarupa of Madhumeha, according to different Acharyas.

Purvarupam Cha17 Su20 A.H27 A.S28 Ma.Ni29

Kesheshu Jatilibhava + + - + -

Asya Madhurya + - + + +

Karapadadaha + + + + +

Karapada Suptata + - - - -

Mukha Talu KanthaShosha + - + + -

Pipasa + + - + +

Alasya + - - + -

Kaye malam + - - + -

Kaya Chhidreshu Upadeha + - - + -

Paridaha Angeshu + - - - -

Suptata Angeshu + -- - + -

Shatpada Pipilika

Mutrabhisaranam

+ - + + -

Mutre Cha Mutra Dosham + - - - -

Visra Sharir Gandha + + + + -

Sarvakala Nidra + - - + -

Sarvakala Tandra + + - + -

Snigdha Gatrata - + - + -

Pichhila & Guru Gatrata - + - - -

Madhur Mutrata - + - - -

Shukla Mutrata - + - + -

25


Sada - + - + -

Shwasa - + - + -

Keshanakhativriddhi + + + - -

Sheeta Priyata + - + + -

Hridaya Netra Jihwa

Shravanopdeha

- - + - -

Sweda + - + + -

Dehe Chikkanata - - - - +

The manifestation of the above mentioned prodromonal symptoms can be

understood in co-relation to the stage of Sthanasamshraya where the already vitiated

and dislodged bodily principles starts to find its substratum vide srotas and its

appendages for the development of further pathogenesis within the latter and finally

enabling the process of Atura Samvedhya and Vaidya Samvedhya Lakshanas which

inturn helps the physician to assess the srotas and its appendages afflicted and plan for

appropriate therapeutic measures based on the Dushyadi Sameekshya Bhava9.

Unexplained fatigue and weight loss has been clinically considered as prodromal

symptoms by modern physicians29.

It is in the nature of this disease; Madhumeha, which withholds the global

systemic illness within its claws that these above mentioned prodromal symptoms

themselves extend to become the cardinal clinical features of the disease. So for the

early diagnosis of this disease – Madhumeha, these prodromal symptoms mentioned

for Prameha - Madhumeha play a pivotal role in guiding and planning the further

course of therapeutic measures with the discretion of the physician based on the

Vikara Vighata Bhava Abhava Prativishesha1.

26


RUPA

The manifesting symptom of a disease which bears its characteristic features is

called Rupa. It represents the Vyakthavastha of Shatkriyakala. Acharya Gayadasa

opines that in case of Prameha, Purvarupa will be manifested as Rupa. This type of

manifestation is termed as Vyadhi Prabhava.

According to Sushrutacharya, the person should be diagnosed as Pramehi

when complete or partial prodromal symptoms of Prameha accompanied by

Prabhoota mutrata get manifested.

Important Samanya Lakshnas of Prameha w.s.r to the Urine

Characteristics:

1) Prabhuta Mutrata (Quantity):

It is considered as the cardinal sign of Prameha by all Acharyas. Acharya

Gayadasa opines on Su.Ni.6/6 that excess urine quantity is because of liquefaction of

the Dushyas and their mutual amalgamation.

It may be suggested that the Prabhuta Mutrata is more akin to metabolic

changes. The excessive urination helps in the elimination of excessive accumulation

of carbohydrate, protein and fat metabolites. The excessive urination is due to an

improper metabolism of carbohydrates, proteins and fats resulting in water and

electrolytes imbalance.

2) Avila Mutrata (Turbidity):

Patient passes urine having hazy consistency. Gayadasa and Dalhana opine

that, the characteristic features of urine are because of the amalgamation between

Mutra, Dosha and Dushya.

Avila Mutrata is more akin to urinary pathology. This Avila mutrata i.e.

turbidity of urine occurs due to body reaction with the Doshas. This can be due to

-27-


presence of phosphates, sugar, sperm, acetone, silicates, albumin, chyle, bile pigments

and salts, blood, pus or casts etc. in the urine. Observed facts contribute to the opinion

that quantity of the urine may remain normal or may be reduced in the later stage of

this disease which in turn depends upon the habit of liquid intake. So, both the

symptoms have been considered as the Cardinal Clinical Features of this disease by

Ancient Seers.

3) Pichhila Mutrata (Consistency):

At the time of diagnosis, Charaka mentioned to consider the etiological factors

also to assess the involved Dosha after knowing the character of urine like Pichhilatha

and Madhurya.

Acharaya Sushruta has described two types of Prameha along with their

manifestations as follows

Sahaja Pramehi (Krisha-Asthenic)

Ruksha (Dry body)

Alpashi (Consumes less food)

Bhrish Pipasa (Voracious thirst)

Parisarpansheelata (Restless, always desires to wander)

Apathyanimittaja (Sthula-Obese)

Bahuashi (Voracious eater)

Snigdha (Unctuous body texture)

Shayyasanswapnasheela (Like to sit down & sleep always)

Acharya Kashyapa has described the following Rupas for Prameha.

(a) Akasmata Mutra Nirgama: Excretes urine suddenly without any intention.

(b) Makshika Akranta Mutra: Flies get attracted towards the urine.

-28-


(c) Shweta and Ghana Mutrata: Passes urine having white colour and of turbid nature.

Along with the above he has also narrated symptoms like Gaurava (Heaviness of the

body), Baddhata (tightness) and Jadata (Procrastination).

Specific Lakshanas of Madhumeha: (Visesha Rupa)

Urine Characteristics:

Madhumehi passes urine having Kashaya and Madhura taste, Pandu Varna

and Ruksha quality. Gangadhara opines on this that the Madhura Rasa of Ojas is

displaced by Kashaya Rasa. Chakrapani opines that Vata, because of its Prabhava

converts Madhura Ojas into Kashaya Ojas.

According to Sushruta, the urine of Madhumehi resembles with that of honey,

as described above. Similar description is found in Ashtanga Hridaya and Ashtanga

Samgrahakara.

CLINICAL FEATURES OF DIABETIS MELLITUS:

Type I Diabetes Mellitus:

Type I Diabetes Mellitus usually begins before age 40 years. This type of

Diabetes is characterized by a rapid onset, with symptoms such as Polydypsia,

Polyuria, Polyphagia, weight loss associated with Random Plasma Glucose level ≥

200 mg/dl. In the fulminating case, the most striking features are those of salt and

water depletion i.e. loose dry skin, furred tongue, cracked lips, tachycardia, and

hypotension and reduced intraoccular pressure. Breathing may be deep and sighing

due to acidosis, the breath is usually fetid and the sickly sweet smell of acetone may

be apparent. Once the symptoms develop, Insulin therapy is required. Occasionally an

initial episode of Ketoacidosis is followed by a symptom free interval (the

“honeymoon” period), during which no treatment is required.

-29-


Type II Diabetes Mellitus:

Type II Diabetes Mellitus usually begins in middle life or later. The typical

patient is overweight. Symptoms begin gradually. Candidal vaginitis or Pruritis

vulvae29 or balanitis is a common presenting symptom since the external genitalia are

especially prone to infection by fungi (Candida) which flourish on skin and mucous

membranes contaminated by glucose due to varied pH within the vaginal canal.

Blurred or decreased vision due to retinopathy is found due to the prothrombotic and

platelet aggregation caused by the endothelial dysfunction. Depression or loss of

tendon reflexes at the ankles and impaired perception of vibration sensation distally in

the legs indicate neuropathy caused due to the accumulation of AGEs which are

neurotoxic in nature25. Hypertension and signs of atherosclerosis are common and

may include diminished or impalpable pulses in the feet, bruits over the carotid or

femoral arteries and gangrene of the feet. Signs of dehydration with associated altered

consciousness are recently noted in cases with severe hyperglycemia. Clinical features

can be classified as follows,

TableNo.4 Clinical Features of Diabetes Mellitus29

SYMPTOMS TYPE – I TYPE – II

Polyuria and thirst ++ +

Weakness or fatigue ++ +

Polyphagia with weight loss ++ -

Ketoacidosis ++ +

Impotency ++ +

Nocturnal enuresis ++ -

Recurrent blurred vision + ++

Vulvovaginitis /Pruritis Vulvae + ++

Peripheral Neuropathy + ++

Often asymptomatic - ++

-30-


We can find more similarities between ayurvedic and modern perception over

the clinical features of Madhumeha vis a vis Diabetes Mellitus like Polyuria -

Prabhutamutrata, Polydipsia - Pipasa Adhikata, Polyphagia – Kshudha Adhikata

etc. They have been discussed as follows,

TableNo.5 Similarities of symptoms in Modern and Ayurvedic views:

MODERN VIEW AYURVEDIC VIEW

Polyuria Prabhutamutrata

Polydipsia Pipasa Adhikata

Weakness and fatigue Dourbalya

Polyphagia Kshudha Adhikata

Glycosuria Avila mutrata - Mutramadhurya

Lassitude Alasya

Increased turbidity and specific gravity

of urine.

Avilamutrata

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SAMPRAPTI

Samprapti of a disease can be literally understood as the process of obtaining

the complete purview of a disease by bridging the discipline of basic fundamental

principles with the clinical observation by studying the specific patterns of vitiation

related to the doshas and dushyas underlying a disease due to its variety of Nidana

and its successive sequential events through the mode of Prasara and

Sthanasamshraya in to various parts or visceras of the body upto the ultimate

expression of the diseased condition and its complications. This indeed due to the

technological advances has become more exciting scientifically and also gained more

importance in relation to the selection of medicine especially in our stream of

medicine – Ayurveda, since all therapeutic modalities are aimed at breaking up this

vicious cycle of pathogenesis -“Samprapti Vighatanameva Chikitsa.”

For the manifestation of any disease condition in the body, the important three

inter-connected factors are Nidana, Dosha and Dushya. Likewise; when these three

factors are not well established within the body, then the occurrence of the disease

will be questionable. The Nidana - Gurvadi, Dosha - Vatadi, and Dushya - Rasadi are

responsible for the manifestation or non-manifestation of the disease. If the Inter-

relationship or Paraspara anubandha of the above three factors are of Hina Bala and

are not connected to each other; then, the chances of manifestation of the disease will

be of considerably low. If these three factors are having less strength and connected

with each other then the manifested disease will not have all the signs and symptoms.

If they are complete and with full strength and their inter-connection is strong enough;

then, the disease occurrence and manifestation can be termed as the Status Ultimatum

with complete clinical manifestation of the disease. However, this in relation to the

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Diabetes Mellitus is termed as Overt Diabetes and possibly can be related to the

Asadya state of the disease Madhumeha.

Prameha vis a vis Madhumeha is included in the group of diseases which are

established in the body due to Santarpana. Charaka Acharya has well established the

sequential events occuring in the process of establishment of the disease by explaining

the Dosha Dushyadi Samprapthi Ghatakas in detail. For better understanding of

Madhumeha Samprapti it is worthy enough to discuss in detail regarding various

patterns of Prameha Samprapti since the other facet of this condition Madhumeha

includes as a category of Vatika Prameha.

Some important points in this concept are natural Kapha in the Prakruta

Avastha is responsible for the existence of Apara Ojas and its corresponding function.

Here in Prameha Samprapti it gets disturbed due to respective preceding etiological

factors mentioned for the vitiation of the dosha, particularly Kapha Dosha.

The Dushya Sangraha is Meda, Mamsa, Shareera Kleda, Shukra, Shonita,

Vasa, Majja, Lasika, Rasa and Ojas. The special characteristic features of these

Dushyas are elicited to be Bahvabadha form.

Due to Nidana Sevana Kapha Pradhana Tridosha Prakopa occurs and Apara

Ojas in Bahudrava Kapha form vitiates Shareera Kleda, Meda, and Mamsa etc. It

further vitiates to reach the Sthanasamsraya stage within Basti along with the Dushyas

and produce Kaphaja Meha. When Kapha Kshaya occurs it will began to vitiate Pita

Dosha and its Anubandha Dushya. As a result Pitha Kshaya occurs and lastly Vata

Pradhana Dosha Dushti occurs and results in Vataja Prameha. These above

descriptions are liable for discretion based on Vyapadeshastu Bhuyasa rule.

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ChartNo.1 SAMPRAPTI OF MADHUMEHA - VARIETY 1

Dushana of Kapha by Nidana

Sahaja Prameha Apathya Nimitaja

Bahudrava Kapha

Dushana of Meda, Kleda, Mamsa etc

Bastiprapti of Dosha and Dushya

Kapha Prameha

Pitha Prameha

Vata Prameha

The above mentioned pattern is the gradual development of the Madhumeha

either through Avarana or Dhatu Kshaya. In other words the Samprapti of Meha can

be discreted according to the Dushyas involved and the dominating Dosha involved.

The possible streak of pathology from Kaphaja Meha to Vatika Meha based on the

Gati and Pradhanata of Dosha, Dushya Samurchana can be explained as follows in the

table.

TableNo.6 Ashraya Ashrayi Bhava9

Dosha Prakopa Dushya Meha produced

Kapha Rasa, Mamsa, Meda, Ojas Kaphaja

Pitta Rakta Pitaja

Vata Remaining Pradhana Dhatus (Vasa, Majja, Lasika,)

Vataja

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Samprapti of Kaphaja Prameha:

After giving a clear picture of these common factors, Acharya Charaka begins

with the causative factors of Kaphaja Meha. With the specification of some Aharas

and Viharas which lead to Kapha Vrudhi, he concludes them by saying that all those

factors which lead to the Vrudhi of Kapha Meda and Mutra are included in the

Nidanas of Kaphaja Meha.

Due to Nidana Sevana the Kapha Dosha undergoes provocation and

Medomamsadi Dushyas are getting vitiated. When these two events occur the Kupita

Kapha – Apara ojas spreads easily and this spreading of Dosha is supported by Ojo

Visramsa and Ojo Vyapath Lakshanas. The affinity of Kapha Dosha towards the

factors of same quality plays an important role here. The liable Medo Vikruthi having

Samanya Bhava with Kapha Dosha combines together. Kapha Dosha due to its

vitiated nature vitiates Medo Dushya also.

The further course of these combo factors in the body is to vitiate the Shareera

Kleda, Mamsa and Vasa due to few Samanya Bhava, this further lead to Vrudhi of

Sharira Kleda and Mamsa dushti. Within this stage of Mamsa Dushti, Rakta Dhatu

and its appendages gets afflicted due to the varied involvement of vitiated pita dosha

which in combination with the above combo factors are responsible for vitiation of

Sveda and Medas in the body successively to create a sufficient amount of Mala

Sanchaya within the disturbed Koshta. All these together inclines towards the

acquisition of Samalatva form of Mutra which is guided towards the corresponding

Mutravaha Srotas to establish the Samanya Lakshana of this condition.

Samprapti of Pitaja Prameha:

Basically the Samprapti of Pitaja Meha is same as that of Kaphaja but the

Nidana which directly provocate Pita Dosha, the latter dosha pita and the affinity

-35-


towards the respective Dushya Dushti with the predominance of pita dosha and

associated with the kapha and vata dosha in establishing varied degrees of clinical

manifestation.

Samprapti of Vatika Prameha:

When an individual who’s Mamsa, Meda, Kleda are already vitiated is

exposed to the Nidanas of Vata Dosha Prakopa, it directly lead to Vatika Prameha.

The Nidana are those which affect Sharira Bala very much like Ativyayama, improper

Shodhana Chikitsa, Atiyoga, Shoka, Bhaya etc. This is the condition when Vata

Dosha undergoes provocation. Then the Kupita Vata Dosha attracted towards the

remaining important Dushyas like Vasa, Majja, Lasika and Ojas. These vitiated

factors reach basti and are eliminated in Mutra form.

Samprapti of Madhumeha1:

Acharya Sushruta opines that if Prameha vis a vis Madhumeha is not treated in

time, they gradually pass to Asadya stage of Madhumeha. Acharya Charaka has

described Madhumeha vividly based on the Vikara Vighata Bhava Abhava

Prativishesha principle. Vagbhata divides Madhumeha into two types, according to

Samprapti. The Asadya variety of Madhumeha is included in Vataja type. If Vata

Prakopa occurs due to Sarvadhatukshaya, it is called Dhatukshayajanya Madhumeha.

And if Vata prakopa manifests as result of Avarana, it is termed as Avaranajanya

Madhumeha.

Different mode of Samprapti of Madhumeha:

The pathogenesis of Madhumeha is explained in Charaka Samhita,

Nidanasthana 4th chapter. Due to causative factors in the person susceptible for

Prameha, Vatakopa occurs. This Kupita Vata Dosha attracts the vital and deep seated

Dhatus like Vasa, Majja, Lasika and Oja to Basti. The Vata Dosha is having

-36-


Rukshatva and it again changes the Madhura Rasa of Oja into Kashaya Rasa. This

Kashaya Oja is excreted through urinary tract later.

Chart No.2 – SAMPRAPTI OF MADHUMEHA - VARIETY 2

a) Madhumeha Due to Kevala Vata:

Due to the Kapha and Pita Kshaya, and with the Kshaya of Vasa, Majja,

Lasika and Ojas, Vata Dosha gets aggravated and draws Ojas towards basti leading to

Madhumeha.

b) Dhatukshayajanya Madhumeha:

The Kshaya of vital dhatus Vasa, Majja, Lasika and Ojas leads to

Vataprakopa. This vitiated vata further makes Ksharana of these dhatus through

Mutravaha srotas resulting in Vasameha, Majjameha, Hastimeha and Madhumeha

respectively. When Kapha and Pita gets depleted Vata gets provocated and it leads to

depletion of Dhatus.

-37-


c) Avaranajanya Madhumeha:

Aharas with the predominance of Guru, Snigdha, Amla and other

Kaphapitakara Nidana leads to the provocation of Kapha and Pita doshas. This in turn

vitiates Medas and Mamsa. These increased dosha-dushya cause avarana dosha by

which normal gati of Vata Dosha is disturbed. Finally vitiated vata carry the

circulating Ojas towards basti resulting in the Madhumeha condition.

d) Apratikarita Madhumeha8:

Acharya Sushruta has described that all types of Prameha - Madhumeha, if not

treated in time, gets converted into Madhumeha. This is the later stage of disease.

SAMPRAPTI GHATAKAS:

a) Dosha:

All the three doshas are responsible in producing Prameha- Madhumeha,

based on Vyapadeshastu Bhuyasa rule - Kapha, Pita and Vata respectively.

(i) Kapha:

A. Bahu and Abadha in Avaranjanya Madhumeha

B. Kshina in Dhatukshayajanya Madhumeha

Kapha Dosha- Apara Ojas has the status as dominant dosha in either type of

Samprapti. The first vitiated dosha is kapha - . Acharya Charaka while describing the

Nidana has used the term ‘Kaphakrut cha sarvam’. It indicates the importance of

Kapha Dosha Dushti and the subsequent Ojas disturbance in Meha. Ojo Vyapat

Lakshanas are well appreciated clinically.

(ii) Pita:

A. Vrudha-in Avaranjanya Madhumeha

B. Kshina- in Dhatukshayajanya Madhumeha

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Status of Pita Dosha is Vrudha in Avaranjanya Madhumeha. In this state due

to respective Nidana, Vrudhi Lakshanas will be manifested. In Dhatukshayajanya

Madhumeha, Vata dosha is in the Kupitha state, So lakshanas related to Pita Dosha

Vikruthi and Vata Dosha are quite evident clinically.

Kshudha Adhikata, Atisweda etc. like Pita Vrudhi lakshanas are evident in

Avaranajanya Madhumeha and Mandagni, Prabhahani etc. like Pita Kshaya lakshanas

are found in Dhatukshayajanya Madhumeha.

(iii) Vata:

A. Avruta- in Avaranjanya Madhumeha

B. Vrudha-in Dhatukshayajanya Madhumeha

It possesses Gati and Yogavahi Svabhava. In Madhumeha the provocation of

this dosha occurs in two ways i.e. Margavarodha and Dhatukshaya .This vitiated

dosha then carries the vital dhatus like Vasa, Majja, Lasika and Oja to basti and

results Madhumeha.

Role of Vyana and Apana:

In Su.Ni.1/20, it is described that Vyana and Apana are the main culprits in

Prameha- Madhumeha. Vyana being pervaded all over the body and Apana in

Vankshana, Vyana acts as the collector of Kleda and Apana as Excretor. The

provoked vata carries the dushyas like Vasa, Majja and Ojas towards Basti and

excretes through urine. Again the excretion of dushyas exaggerates vata provocation

and hence the vicious cycle goes on.

b) Dushyas:

Nidana, Dosha and Dushyas are the three factors responsible for the

manifestation of every disease. But when they are having Anukulatva disease

establishes in its way. So Anukulatva of these factors is important in Madhumeha.

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The ten Dushyas described in Madhumeha are Rasa, Rakta, Mamsa, Meda, Majja,

Vasa, Lasika, Oja, Shukra and Ambu38. Vagbhata Acharya includes Sveda as

additional.39

Citation - Charakasamhita Chikitsasthana, Kleda has been referred to as

Ambu. Acharya Sushruta also have considered the above factors.

Meda is common dushya in all Prameha Samprapti. While considering the

Purvarupa at the Sthanasamshraya level, Keshanakhati Vrudhi mentioned refers to the

mala as a result of Asthi Dhatu. Thus almost all the dhatus are involved in this disease

which leads to either Asadhyatva or Krichrasadhyatva.

Rasa: Rasa is the seat of Kapha Dosha. At the same time, the Prakupita Avasta is

considered as mala of Rasadhatu. So vitiation of Kapha is the result of vitiation of

Rasadhatu. The symptoms like Alasya, Gaurava and Karshya are produced as a result.

Rakta: Mainly connected dushya in Pitaja Meha Samprapti. The symptoms and signs

due to its involvement are Daha, Pidaka, and Vidradhi etc.

Mamsa: It is a seat of Kapha Dosha. The vitiated Meda combines with it and results

in Putimamsa pidakas.

Meda: It is the dominant dushya in all types of Pramehas. Both quantitatively and

qualitatively it is vitiated. Abadhatva is qualitative and Bahutwa is quantitative

vitiation. Shareera Shaithilya is produced by Abadha Meda and Bahutwa of Meda

leads to Dhatwagnimandya. Dhatwagnimandya leads to Medo Vrudhi in turn.

Majja: In the Samprapti of Madhumeha, Majja gets depleted as a result of

Vataprakopa. The provoked vata draws Majja towards Basti and excretes through

Mutravaha srotas leading to Majjameha which signifies the highest degree of

vitiation.

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Shukra: Shukra is having an important role in Sahaja Prameha. Prameha is a Kulaja

Vikara and occurs as result of Beeja dosha. Vyana and Apana are the causative factors

for Shukra dosha and Prameha. Vata causes depletion of Shukra Dhatu and causes

Shukra Meha.

Ojas: Apara Oja is the one disturbed initially which later in Vataja type of Prameha

vis a vis Madhumeha alters its quality and carries towards basti and excretes through

urine. The manifestations like Gurugatrata, Nidra, and Tandra are the result of Oja

Visramsa and Vyapat which finally at the highest degree of vitiation draws the Para

Ojas to cause death.

Kleda: Kleda itself is an important dushya in Prameha. It makes other dushyas

susceptible for the progression of the Samprapti. Kleda promotes analogy between

Dosha and Dushya. The increased Kleda with Bahudrava Sleshma and Bahvabadha

Meda amalgamates with vitiated Doshas and Dushyas resulting in increased amount

and frequency of the urine along with adding Samalatva to it thus altering its

turbidity, specific gravity and transparency.

Vasa: Vasa, the Upadhatu of Mamsa has been described as the predominant dushya

affected in Vataja Prameha. Vasameha is one type of Vataja Prameha which signifies

the highest degree of vitiation.

Lasika: Lasika is one type of body fluid described as - its dushti will be predominant

in Hastimeha.

Sweda: Sweda has been described as dushya by Acharya Vagbhata. Atisweda and

Visra shareergandha occurs as a result of Sveda dushti along with other dushyas.

(c) Srotas: (Medovaha, Mutravaha, Udakavaha)

Mutravaha srotas is mainly involved in this disease. Medovaha, Mamsavaha

Srotodushti also occurs in Madhumeha. Prabhuta Avila mutrata is a result of

-41-


Mutravaha Srotodushti. Purvarupa of Prameha mentioned like, Kaye Malam, Snigdha

Gatrata, and Pichila Gatrata is the manifestations of Medovaha Srotodushti.

Udakavaha Srotodushti produces symptoms like Pipasa Adhikata, Mukha-Talu-Kanta

Shosha. Sharavika, Kachapika etc. like pidakas gets manifested when Mamsavaha

Srotodushti occurs.

d) Role of Agni and Ama:

Madhumeha is a metabolic disorder which is the result of Dhatwagnimandya.

In Ayurvedic concept Pachana tatvas are Jataragni, Bhutagni and Dhatvagni. When

taken food materials are properly digested it can be absorbed for further building up

of the body. Otherwise a non absorbable form is produced after semi digested stage.

This concept is applicable not only to the food ingested by the individual but also can

be applied to the cellular level. The food which is in the semidigested form is not

capable of entering to the Srotomukhas due to pichila, Guru Guna and can be termed

as Ama. In the case of Dhatvagni it helps in the Parinama of dhatus from rasa to

shukra. When it loses its potency or when it is less, it leads to Dhatuvrudhi and vice

versa. Due to specific nidanas, Agnimandya occurs and it further leads to Bahudrava

Kapha and Bahvabadha Meda. Kleda and mamsa also increases within the same stage.

The concept of Agnimandya is the same in case of Avaranjanya Madhumeha

also. Agnimandya occurs in a same way and it leads to the improper digestion of

excessive dhatus and is not assimilated properly leading to the vitiation of the specific

Dhatu. This vitiated dhatu obstructs gati of vata. Due to Kupita vata, Jataragni

increases and it requires more and more food. This further leads to the tendency to

take more food which in turn leads to Medovrudhi- impaired lipid and protein

metabolism.

Samprapti Ghatakas had been summarized as follows.

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Dosha : Kapha Arambhaka Tridoshaja

Dushya: Meda, Mamsa, Shareera Kleda, Shukra, Lasika, Vasa, Majja, Rasa, Rakta

and Ojas1.

Mala: Sveda, Mutra, Kesha, Nakha.

Agni: Jataragni, Dhatvagni

Ama: As the Mandagni leads to formation of Aparipakva Ahara rasa.

Srotas: Medovaha, Svedovaha, Rasavaha, Raktavaha, Annavaha, Mutravaha and

Udakavaha.

Srothodushti: Sanga and Atipravruti.

Udbhavasthana: Amasaya.

Adhishtana: Vapavahana and Vrukkas.

Sanchara Sthana: Mutravaha Samsthana

Vyaktha Sthana: Basti.

Vyadhi Svabhava: Chirakari, Anushangi.

Rogamarga: Bahya Rogamarga as Rasa, Rakta and Mamsa dhatus are involved.

Abhyantara Rogamarga is also involved in the disease as Koshtangas like Amasaya, ,

Pakvashaya, Vrukka etc. are affected – signifying the Global Systemic Affliction.

SAMKHYA SAMPRAPTI OF PRAMEHA (CLASSIFICATION)

Classification of a disease is mainly done for the purpose of proper

understanding of the disease and to formulate an effective treatment protocol. In this

point of view various types of classification of Prameha including Madhumeha has

been described by the ancient Ayurvedic scholars. This has been elaborated as

follows.

-43-


1. Classification based on Nidana (Etiology) 17, 18, 19.

The root cause of disease has enough importance for the prognosis and treatment of

the disease. The occurrence of Madhumeha according to this point of view is of two

types.

A) Sahaja [Heriditary]

B) Apathyanimittaja [Acquired]

A) Sahaja

Sahaja Prameha occurs as a result of Beejadosha i.e. genetic origin16.

While describing prognosis, Acharya Charaka has narrated that Prameha or

Madhumeha occurring due to Beeja dosha is incurable.

B) Apathyanimittaja

Apathyanimittaja type itself suggests its etiology. It occurs due to Ahitahara17.

On analyzing the Samprapti, Apathyanimittaja Madhumeha is of two types.

a) Santarpanjanya: Santarpanjanya Madhumeha which is directly due to intake

of nutritious diet, which are having Kaphavardhaka properties. The excess

intake of such substances will primarily lead to the vitiation of Kapha, Pita,

Meda and Mamsa, which in turn cause Madhumeha by doing avarana of

vata.43

b) Apatarpanjanya: If the substances which deplete the dhatu and aggravate

vata are consumed then it leads to Apatarpanjanya Prameha. They act through

vitiation of vata which in turn leads to the manifestation of Madhumeha.

2. Dosha [Clinicopathological classification]:

Twenty types of Prameha have been described by the different authors of

Ayurvedic Classics. Among these, 10 are of Kaphaja type, 6 are of Pitaja type and 4

belong to Vataja type. They are enlisted below,

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TableNo.7 – Dosha classification of Prameha- Different views

Types Charaka44 Sushruta45 Vagbhatta46 Madhava47

Kaphaja Meha

Udakameha + + + +

Ikshuvalikameha + + Ikshumeha Ikshumeha

Sandrameha + + + +

Sandraprasadameha + Surameha Surameha Surameha

Shuklameha + Pishtameha Pishtameha Pishtameha

Shitameha + Lavanameha + +

Sikatameha + + + +

Shanairmeha + + + +

Alalmeha + Phenameha Lalameha Lalameha

Shukrameha + + + +

Pitaja Meha

Ksharameha + + + +

Kalameha + Amlameha + +

Nilmeha + + + +

Lohitameha + Shonitameha Raktameha Raktameha

Manjishtameha + + + +

Haridrameha + + + +

Vataja Meha

Vasameha + + + +

Majjameha + Sarpimeha + +

Hastimeha + + + +

Madhumeha + Kshoudrameha + +

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3. Classification based on Samprapti: According to mode of Samprapti Prameha

especially Madhumeha can be classified in to two.

a) AvaranjanyaMadhumeha48

In Avaranjanya Madhumeha, Kaphavardhaka Nidanasevana leads to vata avarana,

which in turn leads to Ojas Karshana which comes to the basti and patient passes

Madhura, Kashaya, and Ruksha Mutra, which is said to be Madhumeha.

b) DhatukshayajanyaMadhumeha49

Whereas in Dhatukshayajanya Madhumeha, due to Vatavardhaka nidana,

Vataprakopa occurs and the Madhuratva of Oja is displaced by Kashaya rasa and it is

brought to the basti leading to Madhuvat Mutratyaga, leading to Madhumeha.

4. Prognostic Classification: 50

Prognosis is an inevitable part of Chikitsa so far as a wise physician is

concerned. Success of treatment depends on an unbiased prognosis. On the basis of

the prognosis we can classify Prameha as follows.

TableNo.8 Sadhya Asadhyata

Sadhya Yapya Asadhya

Kaphaja Pitaja Vataja

Sthula (Obese) Usually not much obese Krusha (Asthenic)

Apathyanimittaja (Acquired) Acquired Sahaja (Heriditary)

Early Stage Acute Stage Advanced Stage

Without complication With Complication with Complication

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5. Classification of Prameha- based on physique51

Clinicopathological status of a disease has an invariable relation with physical

constitution of the body in Madhumeha. This has to be taken into consideration when

treatment is formulated. According to this, in Ayurveda, Madhumeha is of two types.

a) Sthula

b) Krusha

PATHOGENESIS OF DIABETESMELLITUS 52

Pathogenesis of type 1 Diabetes Mellitus

This type of Diabetes results from autoimmune destruction of β cell. Three

interlocking mechanisms are responsible for the islet cell destruction. Genetic

susceptibility, autoimmunity and an environment insult. Genetic susceptibility is

linked to specific alleles of the class II major histocompatability complex and other

genetic loci that predispose certain persons to the development of autoimmunity

against β-cell cells of islets. The autoimmune reaction may develop spontaneously or

is enhanced by an environment event like viral infections that alters β-cell cells,

rendering them immunogenic. Overt diabetes developed appears after most of the β-

cell cells have been destroyed.

Pathogenesis of type 2 Diabetes Mellitus

There are two main metabolic defects responsible for this type of diabetes.

One is the derangement in the β cell secretion of insulin and the other one is the

inability of peripheral tissues to respond to insulin (insulin resistance).

Epidemiological studies indicate that type-2 diabetes results from a collection of

multiple genetic defects.

-47-


Derangement in β-cell secretion of insulin

This condition is primarily due to degeneration of β-cells by numerous

mechanisms. One major reason is excess formation of uncoupling protein2 (UCP2)

inside the β-cell cell from a defective mitochondrial pathology which may be fatal to

the β-cells. Another mechanism is the deposition of Amyloid protein inside the

pancreatic islets. Amyloid is toxic to β-cells and may thus contribute to the β-cell

destruction.

a) Insulin resistance

There are three main targets of insulin action-adipose tissue, muscles,

and liver. In both pregnancy and obesity insulin sensitivity of target tissues will

decreases. These failures of utilization of insulin by peripheral tissues are called

insulin resistance. As a result the blood glucose level will be elevated. The relation

between obesity and insulin resistance has been ruled out. Recent studies indicate that

adipose tissue is not merely storage site for triglycerides, but is a versatile endocrine

tissue that can carry out a dialogue with muscle and liver both important targets of

insulin. The adipose tissue secretes 4 important secretions which are having profound

effect on insulin. They are Leptin, Resistin, tumour necrosing factor (TNF), and free

fatty acids. Increased Leptin will decrease obesity and insulin resistance where as all

the other three will promote obesity and insulin resistance. Adequate amount of

Adiponectin – a potent insulin sensitizer is the counter protein within the liver

responsible for reducing insulin resistance and increasing insulin sensitivity.

Modern classification According to etiological factors: 53

A) Type 1 Diabetes mellitus

B) Type 2 Diabetes mellitus

-48-


C) Other Specific types

1. Genetic defects of β-cell function

2. Genetic defects in Insulin action

D) Diseases of the exocrine pancreas

1. Pancreatitis

2. Trauma

3. Neoplasia

4. Cystic fibrosis

5. Others

E) Endocrinopathies:

F) Drug or chemical induced

1. Glucocorticoids

2. Thyroid hormone

3. Thiazides

G) Infection

1. Congenital rubella

2. Cytomegalovirus

3. Others

H) Uncommon forms of immune mediated Diabetes

I) Other genetic syndromes

1. Down syndrome

2. Klinfelter’s syndrome

3. Turner’s syndrome

4. Wolfram syndrome

5. Myotonic dystrophy

-49-


6. Prader – Willi syndrome

7. Friedereich’s ataxia

8. Huntington’s chorea

9. Others

J) Gestational Diabetes Mellitus

K) Others

1. Acromegaly.

2. Cushing’s syndrome.

3. Pheochromocytoma

4. Hyperthyroidism

5. Others.

-50-


SAPEKSHA NIDANA

Acharya Charaka describes that when Madhumeha is present, sometimes it is

difficult to distinguish it from Kaphaja meha because Mutra in Madhumeha is with

Madhura taste and having Pichila Svabhava and appearance like honey. So Acharya

Charaka instructs to consider the presence of Rupa and Nidanas. If there are

symptoms of Dosha Kshaya (Kapha-Pitadi Kshaya in comparison to Vata), then it is

Vatika Prameha and if there is history of Santarpanjanya nidana, then it is

Kaphasambhava Prameha. This is important because if Madhumeha Rogi is having

less strength due to Dhatukshaya and Vatakopa is treated with Kaphamehopakramas

which will be responsible for producing adverse results.70 at the same time this can be

understood well with discretion based on the Vikara Vighata Bhava Abhava

Prativishesha principle. A protocol for differential diagnosis is given below.

TableNo.9 Differential Diagnosis

Sl

No.

Madhumeha Ikshuvalikameham21 Shitameham21

1 Vataja Kaphaja Kaphaja

2 Patients may be Krusha

or Sthula

Patients are Sthula Patients are often

Sthula

3 Symptoms of Oja kshaya No Oja kshaya No Oja kshaya

4 Incurable or Yapya Curable Curable

5 Avilamootrata Avilamootrata Avilamootrata is

absent

6 Chronic Acute Acute

7 Shareera and Mutra

Madhurya

Mutra Madhurya only Mutra Madhurya

only

From the conventional medicine point of view it is considered that all the secondary

causes for Diabetes Mellitus and also secondary causes for temporory hyperglycemic

-51-


state should be considered along with few recent diagnostically productive laboratory

work ups like Serum Fructosamine test and Glycosalated hemoglobin test for a better

Evidenced Based Prognostic Approach. The most important factor to be evaluated

along with these above mentioned factors is the quality of life which is highly

responsible for providing a better picture of the disease state and its prognosis with

the administered medications and lifestyle modifications32.

-52-


UPADRAVA

The term upadrava is applied to a disease which has taken place on, produced

by the sampraptighatakas of original disease and be cured if original disease is treated

successfully.

Acharaya Charaka enumerated the general complications whereas Achraya

Sushruta and Acharya Vagbhatta described according to the Dosha predominance.

(1) General Complications54

Trishna, Atisara, Daha, Daurbalya, Arochaka, Avipaka, Putimamsa, Pidaka,

Alaji, Vidradhi etc.

(2) Specific Complications:

(a) Kaphaja meha55

Makshikopasarpanam, Alasya, Mamsopachaya, Pratishyaya, Shaithilya,

Arochaka, avipaka, Kaphapraseka, Chhardi, Nidra, Kasa and Shwasa are said to be

complications of Kaphaja meha.

(b) Pittaja meha56

Vrushanayoravadaranam, Bastibheda, Medhra toda, Hridshula, Amlika, Jwara,

Atisara, Arochaka, Vamathu, Paridhumayanam, Daha, Murchha, Pipasa, Nidranasha,

Panduroga, Pitavinmutranetratva and Vidbheda (A.H.) are said to be the complication

of pittaja meha.

(c) Vataja meha57

Hridgraha, Laulya, Anidra, Stambha, Kampa, Shula, Baddha purishatva and

shosha, kasa, shwasa are said to be the complication of vataja meha.

‐ 53-


Complications of Madhumeha: Acharaya Charaka has mentioned 7 types of pidaka

as complication of madhumeha, while Sushruta and Vagbhatta have mentioned 10

pidakas. Sushruta has mentioned that madhumeha along with pidaka is asadhya. He

narrated that these pidaka occurs due to Tridosha and vitiated meda and mamsa.

Table No.9 Prameha Pidaka

Pidaka Charaka58 Sushruta59 Vagbhatta60

Sharavika + + +

Kacchhapika + + +

Jalini + + +

Sarshapi + + +

Alaji + + +

Vinata + + +

Vidradhi + + +

Putrini - + +

Masurika - + +

Vidarika - + +

COMPLICATIONS OF DIABETES MELLITUS61

Complications of Diabetes mellitus fall into two major divisions i.e. Acute

Complications and Chronic Complications. The complications resulting from the

disease are associated with the damage or failure of various organs such as the eyes,

kidneys and nerves.

Acute Complications

Diabetic Ketoacidosis and Non Ketoic hyperosmolar state are the acute

complication.

Chronic Complications:

(1) Macrovascular Complications:

Coronary artery disease.

‐ 54-

Peripheral Vascular disease.


Cerebro vascular disease.

(2) Microvascualar Complications:

• Diabetic Eye disease

Retinopathy (non-proliferative/proliferative)

Macular edema

Glaucoma

Cataracts

• Diabetic Neuropathy

Poly neuropathy /mono neuropathy

Autonomic neuropathy.

(3) Other

Gastro intestinal [gastroparesis, diarrhoea]

Genito urinary [uropathy /sexual dysfunction]

Dermatologic infections.

Diabetic foot.

(A) Acute Complications:

Diabetic Ketoacidosis [DKA]:

Ketoacidosis is one of the most serious metabolic complications of diabetes,

even if managed properly. It can be developed for individuals with type1 DM.The

prognosis substantially worsened at the extremes of age and in the presence of coma

and hypotension.

Clinical Features:

Nausea, vomiting, thirst, polyuria, abdominal pain, altered mental function are

the clinical features of DKA.

Physical Findings:

‐ 55-

Tachycardia, Dry mucous membranes, reduced skin turgor, Dehydration,

hypotension, Tachypnea, Kussmaul respirations, respiratory distress, abdominal


tenderness, Fever, Lethargy, Obtundation, Cerebral edema and possibly coma are the

physical findings of DKA.

Precipitating Factors:

Infection, Cerebrovascular Accident, Myocardial infarction, Alcohol abuse

and discontinuation of or inadequate insulin is the main precipitating factors for DKA.

Treatment:

Correction of dehydration, hyperglycemia and electrolyte imbalances is the

treatment modalities for DKA. Identification of precipitating factor and frequent

patient monitoring are also important.

Non Ketoic Hyperosmolar State [NKHS]:

Clincial Features:

Polyuria, Orthostatic hypotension, Lethargy, Altered mental status,

Obtundation, Seizure and Coma is the clinical features of NKHS.

Physical Findings:

Dehydration, Hyperosmolality, Hypotension, Tachycardia and Altered mental

status are the main physical findings of NKHS.

Precipitating Factors:

Concurrent illness such as myocardial infarciton, stroke, sepsis, pneumonia,

debilitating conditions like dementia are found to be the main precipitating factors for

NKHS.

‐ 56-


Treatment:

Correction of dehydration, Insulin administration and Frequent Patient

Monitoring are the treatment modalities.

(B) Chronic Complications:

Chart No. 3 - Mechanism of developing chronic complications62

Hyperglycaemia

Activation of protein kinase C

Formation of advanced glycation end products (AGE)

Activation of polyol pathway

Endothelial nitric oxide synthase uncoupling

Activation of protein kinase C

Activation of reactive oxygenease

Induction of DNA damage

Reduction of nitric oxide bioavailability

Altered gene expression

Increased AGE formation

Induction of oxidative stress

The possible mechanism of complication is yet to be elucidated.

Three theories have been proposed for the mechanism of complications.

‐ 57-

One hypothesis proposes that increased intracellular glucose leads to inceased

sorbitol wich aris a polyol. Some glucose converts into sorbitol by aldose reductase.

Increased sorbitol concentrations leading to cellular dysfunction will exhibits the

complication of Diabetes Mellitus.


Second hypothesis suggests that increased intra cellular glucose levels leads to

the formation of Advanced Glycosylation End products (AGEs). AGEs modulate

atherosclerosis, accelerate glomerular dysfunction, decrease nitric oxide synthesis,

and promote endothelial dysfunction which leads to complication by altered cell

function.

Third hypothesis has been explained in following manner. Increased

hyperglycemia increases the formation of diacylglycerol which activates certain

isoforms of protein kinase C, which leads to complications through altered gene

expression or growth factors.Increased level of growth factors such as, Platelet

derived growth factor, epidermal growth factor & vascular endothelial growth factor

leads to complication of Diabetes mellitus.

Glycemic control and Complications:

The DCCT (Diabetes Control and complications Trial) results postulated that

improvement of glycemic control reduced nonproliferative and proliferative

retinopathy, micro albuminuria, clinical nephropathy and neuropathy. The United

Kingdom Prospective Diabetes study results establish that retinopathy, nephropathy

and neuropathy are benefited by lowering blood glucose levels in type 2 diabetes with

intensive therapy. The overall complication rate was decreased by 60% with intence

therapy and strict glyceamic control.in patients with type1 diabetes strict glyceamic

control achieved a substancially lower HbA1c (7.2%) than individuals in the

conventional diabetes management group (HbA1c of 9%).

(1) Diabetic Retinopathy:

Diabetic Retinopathy is a most frequent cause of blindness among adults aged

20-74 yrs. Diabetic retinopathy is classified in to two stages proliferative and non

proliferative.

‐ 58-


Nonproliferative diabetic retinopathy usually appears late in the first decade or

early in the second decade of the disease and is marked by retinal vascular

microaneurisms, blot heamorrhages and cottonwool spots.

The appearance of neovascularisation in response to retinal hypoxia is the

hallmark of proliferative Diabetic retinopathy.they rupture easily and leading to vitrial

hemorrhage, fibrosis and ultimately retinal detachment.

(2) Diabetic Neuropathy63:

Diabetic neuropathy occurs in approximately 50% of individuals with

continuum of hyperglycemia in type 1 and type 2 diabetes mellitus. It may manifest as

polyneuropathy, mononeuropathy and autonomic neuropathy.

Polyneuropathy

Manifestations:

Distal sensory loss, Hyperesthesia, Paresthesia, Pain [usually in lower extremities]

Physical findings:

Sensory loss, Loss of ankle reflexes, Abnormal position sense, Parethesia

[sensation of numbness, tingling, sharpness or burning]

Diabetic polyradiculopathy is a syndrome characterized by severe disabling

pain in the distribution of one or more nerve roots.

Mono neuropathy:

It presents with pain and motor weakness in the distribution of a single nerve.

Involvement of the third cranial nerve is most common.

Physical findings:

Ptosis, Opthalmoplegia with normal papillary constriction to light can be

noted.

Peripheral mononeuropathies or simultaneous involvement of more than one

nerve (Mononeuropathy multiplex) may also occur.

‐ 59-


Autonomic neuropathy:

Individuals with long standing type- 1 or type- 2 Diabetes may develop

autonomic neuropathy involving multiple systems, like the cardiovascular system,

genitourinary system, gastro intestmal tract, psudo motor system and metabolic

systems.

As a result of sympathetic nervous system dysfunction hyperhidrosis of the

upper extremities and anhidrosois of lower extremities occurs which promote dry skin

with cracking. Autonomic neuropathy may reduce counter regulatory hormone

release, leading to an inability to sense hypoglycemia.

3. Diabetic nephropathy:

Diabetic nephropathy is an important cause for morbidity and mortality,and is

now among the most common causes of end-stage renal failure(ESRF)in developing

countries. As it is found with other microvascular and macrovascular complications,

management is frequently difficult and the benefits of prevention is substantial.About

30% of patients with type1 diabetes have developed diabetic neuropathy after 20

years and epidemiological data suggested that the over all incidents is declining as

standards of glyceamic control increased.microalbuminuria is an important indicator

of risk developing nephropathy and more reliable for type1 diabetes than type2

variety.risk factors for developing diabetic nephropathy includes poor control of

blood glucose,long duration of diabetes,presense of other microvascular

complications,familyhistory etc.

(4) Cardio vascular disease64

Cardiovascular disease is the leading cause of mortality for with diabetes.

Type 2 diabetes is an Independent risk factor for macrovascular disease and its

common coexisting conditions i.e. hypertension & dyslipidemia.

‐ 60-

Hypertension (blood pressure > 140/90 mmHg) is a common comorbidity of

diabetes, affecting 20-60% of people with diabetes, depending on age, obesity and


ethnicity. Lowering of blood pressure with regimens based on antihypertensive drugs,

including ACE inhibitors, angiotensin receptor blockers (ARBs), B-blockers, diuretics

& calcium channel blockers has been shown to be effective in lowering cardio

vascular events.

Patients with type 2 diabetes have an increased prevalence of lipid

abnormalities. Which account for higher rates of CVD. The most common pattern of

dyslipidemia in type 2 diabetic patients is elevated triglyceride levels. Type 2 diabetic

patients typically have a preponderance of smaller, denser LDL particles, which

possibly increases atherogenicity even if the absolute concentration of LDL is not

significantly increased.

Table No. 10. Abnormal Lipoprotein levels in adults with Diabetes Mellitus.

LDL Cholesterol HDL Cholesterol Triglyceude

> 130 <40 > 400

(5) Gastrointestinal Dysfunctions:65

Symptoms:

Delayed Gastric Emptying [gastropresis], Altered small & large bowel

Motility [Constipation or diarrhoea], Anorexia, Nausea, Vomiting, Early satiety,

Abdominal bloating.

(6) Genito urinary Dysfunction:

• Cystopathy

• Erectile dysfunction

• Female sexual dysfunction

• Dyspareunia

• Vaginal Lubrication

‐ 61-


(7) Diabetic Foot: 66

Foot ulcers and amputations are a major cause for individuals with diabetes.

The risks of ulcers or amputation increased in people who have had diabetes > 10

years have poor glucose control have renal, retinal or cardio vascular complications.

Clinical features include neuropathy and ischemia which presents with

parasthesiae, pain, numbness, claudication, ulcer, gangrene, Osteoomyelitis etc.

Table No.11 Complications of Diabetes according to modern and ayurvedic.

MODERNVIEW AYURVEDIC VIEW

Carbuncles Pidakas

Diabetic gangrene Poothimamsatha

Gastrointestinal disfunction Pipasa,arochaka,avipakaAtisara

Lethargy Dourbalya

Genital dysfunction Vrushanayoravadaranam

Nephropathy,Retinopathy

Neuropathy

Saithilyam (Netra, Muthravahasrothas,

Nadisamsthanam).

‐ 62-


ARISHTA LAKSHANA

The following two features are mentioned by Acharya Charaka as arishta

lakshana i.e.the signs of incurability or indication of ensured death which are highly

liable for physician’s cognitive discretion.

1. According to Acharya Charaka, the person in whose body, the flies are attracted

after bath also is sure to die due to Prameha. 68

The sweetness of body is in large proportion in prameha and after bath also the

skin remains sweet. Extensive hyperglycemia may produce diabetic coma and patient

may die.

2. Acharya Charaka also says that the person who drinks various kinds of oils and

ghees or other unctuous preparations with Chandala in his dreams may die of prameha

in future.69

This shows the relationship between altered bodily functions in Madhumeha

and its impact in the mental status. Unctuous preparations like oils and ghees are the

representatives of soumya dathus. Here chandala represents the altered status of

soumya dhathu’s like Vasa, Majja, Ojas, Meda, Kleda etc.

‐ 63-


DIAGNOSIS OF DIABETES MELLITUS71

It is the early diagnosis of Diabetes Mellitus which is finding more importance

in the Healthcare domain than mere diagnosis, which is also of great important

because it helps in two perspectives regarding the management of the disease.

1. Firstly, it helps in defining the threshold for various interventional strategies

aiming to control symptoms and ameliorate development of short term and long

term complications.

2. Secondly, it helps in epidemiological studies to estimates its prevalence and

incidence along with the risk factors which inturn helps to strategise the

preventive and therapeutic measures.

Amidst the various technological advances in medicative therapy it is the early

diagnosis which has still remained as an enigmatic topic of discussion in any stream

of medicine. Good news for the Ayurvedic physicians is that they have the emeritus

tool for discreting the condition for early diagnosis of this dreadly creeping disease.

Diagnostic Criteria

Currently accepted diagnostic criteria across the world are those proposed by

the expert committee of American Diabetic Association in 1997 and accepted by

WHO in 2009. The same criterion used by DCCT for its clinical studies on diabetes

mellitus has been used for the present study.

‐ 64-


TableNo.12. WHO approved Diagnosis Criteria for Diabetes Mellitus

WHO approved Diagnostic Criteria of Diabetis Mellitus

Venous plasma Capillary blood

Fasting ≥126mg/dl >110mg/dl

2 hrs post glucose ≥200mg/dl >200mg/dl

Random blood glucose ≥200mg/dl

In a patient who is having cardinal symptomatology of diabetes mellitus

(Polyphagia, Polyuria, Polydypsia Unexplained Weight Loss, Drowsiness or Coma),

Fasting Plasma Glucose Level ≥126mg/dl or 2hrs post 75 gm glucose level ≥

200mg/dl is considered as the Diagnostic Criteria for Diabetes Mellitus. Fasting

plasma glucose level (FPG) less than 100mg/dl is considered as normal. However

FPG level of 101-125mg/dl is considered as IFG (Impaired Fasting Glucose) and is

refered to pre-diabetic condition.

TableNo.13 Impaired Fasting Glucose Level

Impaired Fasting Glucose

Venous plasma Capillary whole

blood

Fasting 100-125 mg/dl NA

2 hrs post glucose ≤140 mg/dl ≤140 mg/dl

If performed ≤200mg/dl ≤200 mg/dl

Oral Glucose Tolerance Test (OGTT)

In asymptomatic individuals, individuals with IFG and those with Random

Plasma Glucose level between 100-200mg/dl an OGTT is strongly recommended for

diagnosis.

‐ 65-


Precautions

1. It should be done in the morning after unrestricted carbohydrate diet and

usual physical activity for previous 72 hrs.

2. The subject should be fasting for atleast 10 -16 hours before the test (may

drink water).

3. The subject should not be smoking during the test.

4. Any concomitant medication, infection or inactivity must be recorded and

be taken into consideration while interpritting the results.

Procedure:

The test should be performed with 75g of anhydrous glucose in 150 – 300 ml

of water over the course of 5 mins. Children should be given 1.75gm/kg of body

weight, upto a total of 75g glucose. Blood should be collected in a tube containing

sodium fluoride (6mg/ml of whole blood) and centrifuged properly to separate out the

plasma. Two hours post glucose value of more than 200mg/ dl is considered

diagnostic for diabetes, while values ranging between 140-200 mg/dl are considered

Impaired Glucose Tolerance (IGT).

TableNo.14. Impaired Glucose Tolerance Test

Impaired Glucose Tolerance

Time Venous Plasma Capillary whole blood

Fasting(if measured) < 126 Mg/dl or < 7

mmol/L

< 110 Mg/dl or< 6.1 mmol/L

2 hours post glucose 140- 199Mg/dl or 7.8- 11.0

mmol/L

140- 199Mg/dl or 7.8- 11.0

mmol/L

‐ 66-


Glycosylated or Glycated Heamoglobin – HbA1C123

In normal individuals a small proportion of heamoglobin combines with the

circulating blood glucose and this fraction is called glycosylated or glycated Hb. This

can be separated in to 3 types HbA1a, HbA1b, and HbA1c. More binding is to HbA1c.

The binding of glucose to Hb is a non-enzymatic process that occurs

continuously through out the lifespan of the RBC. Once glycated the elevated levels

persists till the red cell dies.

The amount of glycated Hb reflects the efficacy of glycemic control in a

diabetic patient during the 8-12 week period before the blood was collected. Normal

level of HbA1C is below 7%. Elevation of HbA1C above this value is evidence of a

condition which is in need of glycemic control during the preceding 8-12 weeks. It

reflects the radical changes in diet or modes of therapy approximately 3-4 weeks after

the initiation of the change. HbA1C is now considered as the most important

diagnostic criteria which help in detecting an unknown hyperglycemic episode within

a span of 2 yrs and the goal of the any treatment in type-2 diabetes being achieving

the HbA1C level <7% along with Fasting and Post Prandial Blood Sugar Level

between 90-130 mg/dl and below 180 mg/dl respectively.

Commonly used techniques for its measurement are chromatographic and

thiobarbitone calorimetric method. It is wise enough to keep in mind that the inter

laboratory variations are high due to lack of standardization. There are few factors

which influence falsely elevated levels of HbA1C and they are,

1. Fructose rich diet.

2. Hyperlipedemia.

3. Uremia.

‐ 67-


4. Elevated temperature and elevated pH of the blood.

There are few factors which influence false low values like,

1. Pregnancy.

2. Anemia.

3. Post blood transfusion period.

4. Low temperature and low pH of the blood.

Advantages:

1. It is useful for assessing long term blood sugar control.

2. The levels of the blood glucose can be easily manipulated by the patients by

taking extra dose of the OHA or insulin or even missing meals on the day of

test so that patient can get good results but HbA1C is unaffected by time, type

of blood sample either venous or capillary, even fed or fasting state.

Disadvantages:

1. It cannot help in diagnosing hypoglycemic episodes or even diabetic

ketoacidosis.

2. It is sometimes possible to obtain normal values in patients suffering from

frequent and dangerous episodes of hypoglycemia, if these are balanced by

other episodes of excessive hyperglycemia.

3. It is highly dependent on the life span of the RBC.

4. If it is measured by electrophoretic method and patient who drink 30 or more

units of ethanol per week then the values may be higher due to the

acetaldehyde derived from the ethanol binds non enzymatically to side chain

of Hb which moves in same direction. This is ovecomed through

electroendosmosis method.

‐ 68-


5. It is not useful for day-to-day management and in adjusting the dose of insulin

or oral anti diabetic drugs.

RELATION TO THE DIABETIC COMPLICATIONS:

The process of glycation is highly indicative of susuceptibility for short term

and long term Microvascular and Macrovascular complications as well as various

neural dysfunctions. Thus it is also indicative of the extent and rate of progression of

retinopathy and neuropathy although the genetic determinants of tissue susceptibility

and independent triggering factors like HTN can also influence the clinical course in a

varied degree of manifestation.

PROPHYLACTIC MEASURES FOR GLYCATION:

Based on recent studies it is now known to the conventional stream about the merit

and demerits of thiamine pyrophosphate and aminoguanide with its analogues as the

prophylactic measures in inhibiting the rate of formation of AGEs but, since it has its

root in the rate and extent of immunoresponsive tissue response and its respective end

products with its timely elimination from the system which is still an enigmatic topic

for its clinical execution from the conventional stream due to its limited extent of anti-

oxidant therapy.

DETECTION OF URINE SUGAR72

The time honoured test for qualitative detection is by boiling urine with copper

containing fehling’s reagent or benedict’s reagentwhich is reduced by glucose and the

blue colour is changed to yellow through red depending upon the amount of

glucose.Eight drops of urine(0.5ml) are added to5mL of benedict’s reagent and boiled

for 2 minutes,cooled and colour is noticed.Sugars reduce the copper and produce

colours ranging from green to brick red,depending upon their concentration.this

‐ 69-


colour is compared to the colour of the reagent before heating.this test is nonspecific

since several sugars like fructose, lactose, galactose, aspirin, VitC and many drugs

may give a positive result.

Specific test for glucose is the glucoseoxidate test,test papers beingavailable

commercially,based on specific enzyme mediated reactions which can also be

quantitated.Test strips are unaffected by the other sugars or drugs.

CLINICAL SIGNIFICANCE:

The high blood glucose causes more glucose to filter into the renal tubules

than can be reabsorbed, and the excess glucose spills into the urine.This normally

occurs when the blood glucose concentration rises above 180 mg/100 ml, a level that

is called the blood “threshold” for the appearance of glucose in the urine.When the

blood glucose level rises to 300 to 500 mg/100 ml—common values in people with

severe untreated diabetes—100 or more grams of glucose can be lost into the urine

each day.

‐ 70-


SADHYASADHYATA

Prognosis forms the Culminative part of Chikitsa so far as a wise physician

and his discrete plans of treatment are concerned. Success of the treatment depends on

an unbiased prognosis; but in this condition in the present era, it is liable for discretion

based on Vikara Vighata Bhava Abhava Prativishesha. Generally the concept of

prognosis in the case of Madhumeha is given by all acharyas as Kaphaja Madhumeha-

Sadhya, Pittaja Madhumeha-Yapya and Vataja Madhumeha-Asadhya, when occurred

due to Dhatukshaya and Krichrasadhya when the whole pathology underlying is well

established due to avarana.

Prognosis of Kaphaja Madhumeha

Charakacharya illustrated the prognosis of this disease by considering the

presence or absence of poorvarupas. Kaphaja meha with poorvarupas are considered

Krichrasadhya while the one associated with pittaja meha is described as

Pratyakhyeya. Acharya Chakrapani opines that, appearance of poorvarupa in the latter

is a cardinal sign of incurability; which, as a general rule can be applied to any disease

but with discretion. Here in the context of Madhumeha, the presence of all or few

poorvarupas like Visrasharirgandham can be considered as asadhyatva.

The second concept of prognosis is connected with medodushti .If the

medodushti is to a lesser extent, then the disease can be easily cured.So it is important

to consider the gradation of poorvarupas as well as the extent of medodushti for

having a concept of prognosis in meha. Keeping the above concepts in mind, the

sadhyasadhyata can be derived as Kaphaja meha is Sadhya, Kaphaja meha associated

with few poorvarupas is Krichrasadhya, Kaphaja meha having all the poorvarupas is

Asadhya, Kaphaja meha with severe medodushti is Asadhya, Kaphaja meha with both

profound medodushti & poorvarupas is Asadhya, Kaphaja meha & associated

‐ 71-


congenital factors is Asadhya and Kaphaja meha with few poorvarupas but with

severe medodushti is Asadhya.

Prognosis of Pithaja and Vathaja Madhumeha

Pitaja Madhumeha is considered as yapya, while Vataja madhumeha are

having the status of Asadhyatva. This is the result of the nature of disease and

associated dhatus.Kaphaja meha can be treated with katu, tikta& kashaya rasas, then

both the kapha dosha and the associated Samadhatus can also be treated with the same

treatment at the same time. In case of Pittaja Madhumeha and Vataja Madhumeha, the

disease and associated vitiated dhatus are having opposite qualities. So yapyatva &

asadhyatva arises respectively.

Pitaja Madhumeha is explained to be with this status.The disease requires

continuous treatment. Once the treatment is stopped the disease is again provoked.

Also Vishamakriyatvat i.e. the doshas are conquered by Langhana Therapy but the

associated vitiated dhatus suffer simultaneously. This also leads to yapyatva.

Prognosis of Madhumeha

Madhumeha in terms of specific type and asadhyata is one among the Vataja

Prameha explained. Here vata provocation might be due to sarvadhatukshaya as it

occurs after kaphaja & pittaja Madhumehas. Another important cause is Avarana.

When vata provocation is due to dhatukshaya the type is included in asadhya

Madhumeha, while the other produced by avaranjanaya vata is considered as

Krichrasadhya. Charakacharya mentioned that Madhumeha produced due to

beejadosha is incurable.

Considering all possibilities the prognosis of the disease Madhumeha can be

summarized as follows.

‐ 72-


MODERN PERSPECTIVE ON PROGNOSIS:

Diabetes is not a curable disease; the treatment Strategy is to enable patients to

lead lives Similar to those of healthy persons, while preventing complications

through appropriate timely Treatment and Personal Management. To achieve this

objective, it is important to reduce Psychological, Physical, and Lifestyle Burdens and

restrictions due to diabetes as much as possible. So, evaluation of health-related

quality of life (HRQL) is of more important for evaluating the burden on patients and

in selecting appropriate therapeutic method. Health Related Quality of Life

measurement provides a Comprehensive evaluation of the patient’s health status

which would provide additional Information to laboratory data and also with the

subjective symptoms which in turn Indicates the Importance of Dinacharya and

Rutucharya for both healthy and unhealthy Individuals.

‐ 73-


CHIKITSA

The principles of the therapeutic measure form the core part of the strategies

for the proper management of the disease especially if Madhumeha is taken into

consideration because of peculiar vyadhi swabhava and Atura. The samprapti should

be considered deeply before stepping into the management.

CHIKITSA SUTRA:

The eminent ancient ayurvedists, Charaka, Sushruta and Vagbhata are

considering the body constitution and strength of the body of the patient when dealing

with the management aspect.Charakacharya considers two types of patients, one is

that with stout body structure and with strength and the other without strength and

krisha. Sushrutacharya also says that sahaja meha rogi will be krisha and

apathyanimittaja rogi will be sthula.73

In the context of medoroga, the managements described are parallel to that of

meha since the dosha and dushyas are same to major extent. After considering all the

factors the two types of management emphasised are:

(1) Samshodhana Chikitsa: [Elimination Therapy]

(2) Samshaman Chikitsa: [Normalizing Therapy]

Like every disease, those factors which are responsible for the production of

the diseases are if eliminated and if further, causative factors are prevented meha can

also be treated. Madhumeha can be treated in this way although it is described as

incurable. In Pratyakhyeya vyadhis, symptomatic relief can be given by proper

management.

-75-


KAPHAJA PRAMEHA:

(i) Samshodana Chikitsa:

It is better to treat the patient with vaman therapy. Charakacharya describes

that shodhana, vamana and langhana done at the proper time looking at the condition

of the patient is able to cure kaphaja meha. 74

For Bastichikitsa Vagbhata describes the utilization of Surasadi gana kwatha.

Acharyas after explaining the shodhana treatment give samshaman Chikitsa in every

type.

(ii) Samshamana Chikitsa:

Charakacharya gives 10 combinations of drugs to all the mehas with kapha

predominance. 75

According to Sushruta, after proper samshodhana the patient should use

swarasa of amalaki with Haridra powder with madhu.76

Acharya Sushruta in this context explains single drug decoctions with separate

indications in 5 types of kaphaja meha and combinations in other 5 types.77

Vagbhatacharya describe three yogas in this aspect. They are as follows

Lodhradi- Lodhra, Abhaya, Musta, Katphala

Pathadi - Patha, Vidanga, Arjuna, Dhanyaka

Gayatrayadi - Khadirsara, Darvi, Vidanga, Vacha 78

Importance of Apatarpana:

Charakacharya explains the cause of prameha as due to increasing attitude of

kleda, meda and kapha. So he emphasise the role of Apatarpana in kaphaja and

Pittajaprameha79.

Different types of vyayama, kshut, udvartana, dhara and snana with churnas

made of Chandana, Aguru, and Ela etc. are advised to use in kaphaja meha.80

-76-


PITAJA PRAMEHA:

(i) Samshodhan Chikitsa:

Virechan is best in pittaja pramehas. The drugs which are sufficient to

eliminate morbid pitta can be used with sheeta and other tikta, kashaya rasa in this.

Nyagrodhadi gana kwatha is advised for Asthapanbasti by Acharya

Vagbhata.Acharya Sushruta has described that due to spreading of medo dhatu all

over the body, Madhumehi subjects are durvirechya.81

(ii) Samshaman Chikitsa:

Acharya Charaka explains 10 pada yogas in this aspect to treat pittaja pramehas.

Sushrutacharya has described 6 specific kwatha yogas for the specific type of pittaja

prameha. 82

The three kwatha yogas explained by Acharya Vagbhatta are,

Ushiradi: Ushira, Lodhra, Arjuna, Chandana.

Patoladi: Patola, Nimba, Amalaki, Amrita

Lodhradi: Lodhra, Ambu, Kaleyaka, Dhataki83

VATAJA PRAMEHA:

Although vatika mehas are incurable still Acharya Charaka explains to induce

certain treatment in kaphapittanubandhi Vatika meha84.

Achrya Sushruta has described that all types of prameha if not treated properly

in time, gets converted into Madhumeha.85 So the treatment described for vatika meha

can be considered as treatment of Madhumeha.

MADHUMEHA:

(i) Samshodhana Chikitsa: 86

Considering Sthula and krisha pramehi, Samshodhana Chikitsa should be

administered only to the Sthula and Balvan Pramehi86. Sarshapa, Nimba, Danti,

-77-


Vibitaki and Karanja siddha Taila or Trikantakadya Sneha (Ghrita or Taila) according

to dosha predominance should be used for Abhyantara Snehana. Here while

explaining the Samshodhana, Charaka describes to use the Malashodhan yogas from

Kalpasthana. Both Pitta and kapha are eliminated through shodhana. It may be

vamana or virechana, because of; Pittantam Vamanam, Kaphantam Virechanam. In

Virechana pitta is eliminated first, then Samyak lakshana of virechana is

kaphadarshan, so both pitta and kapha doshas which are vitiated are eliminated. Then

the described Anuvasana and Asthapana Basti chikitsas are able enough to control the

provocation of vata. Like this all the doshas are normalized to keep the dosha

samyata. Anuvasana with medicated oils and ghritas are prescribed in Madhumeha.

After proper Shodhan Chikitsa, Charakacharya details to give santarpan chikitsa to the

patients, to prevent the complications like Gulma, Bastishula etc.

(ii) Samshamana Chikitsa:

Samshamana Chikitsa includes mainly deepana (appetizers) , Pachana,

(enhancing digestion), Kshut (Hunger maintenance), Trit (Maintenance of thirst),

Vyayama (Exercise), Atapa (Having exposed to sunlight ) and Maruta ( Exposing

oneself to wind).According to the conditions of vitiated doshas & dushyas , vaidya

has to suggest proper Shaman Chikitsa to the patient.

Acharyas introduces different tarpana upakramas in vatika mehas. It is due to

the less strength of the patient. Acharya Charaka and Vagbhatta says that the kashaya

yogas should be enriched with sneha and given to vatika mehas.

Typical Madhumeha Chikitsa: 87

Acharya Sushruta explains that Shilajit should be taken after triturating with

Salsaradi gana kwatha. After its digestion patient should take Jangalamamsarasayukta

Anna. He prescribes to take 1 Tula of shilajatu.

-78-


Swarasa: Amalaki, Haridra, Nimbapatra, Bilwapatra, Guduchi

Kwatha: Vidangadi, Phalatrikadi, Mustadi, Manjishthadi, Pathadi

Churna: Triphaladi, Mustadi, Gokshuradi, Arkadi

Gutika: Chandraprabha, Indravati, Pramehantak Vati

Gugglu: Gokshuradi Guggul

Modaka: Kastur Modaka

Avleha: Kushavleha, Bangavleha

Paka: Pugapaka, Ashwagandhadi paka, Draksha Paka.

Asava Arishta: Lodhrasava, Dantyasava, Madhukasava, Devdarvyadiarishta,

Lodhrarishta.

Ghrita: Dhanvantar ghrita, Trikantakadi ghrita, Sinhamrita ghrita, Dadimadi ghrita,

Shalmali ghrita.

Rasaushadhi:Vasant kusumakar Rasa, Mehamudgar Rasa, Brihat Bangeshwar Rasa,

Prameha gajkesri Rasa, Tribanga Bhasma, Vasant tilaka Rasa.

TREATMENT OF DIABETES MELLITUS88

Goals of treatment of diabetes:

Diabetes mellitus requires ongoing medical care as well as patient and family

education both to prevent acute illness and to reduce the risk of long term

complications. The management of diabetes patient is not aimed solely at glycemic

control to restore known metabolic derangements towards normal in order to prevent

and delay progression of diabetic complications. The aims of treatment have been

varied according to an arbitrary division of patients into three categories ranging from

those in whom symptomatic relief done seems the most appropriate or any attainable

goal to those in whom an attempt at maximal prophylaxis against future tissue

damage seems desirable and possible.

-79-


Oral Drugs for Treating Hyperglycemia: 89 Oral drugs are used to lower Blood

glucose level by achieving following goals.

1. Drugs that primarily stimulate insulin secretion

2. Drugs that alter insulin action.

3. Drugs that principally affect absorption of glucose.

Mainly used drugs are Sulphonylureas and Biguanides.

Sulphonylureas: These drugs stimulate production of Insulin initially but later on

they act by their extra pancreatic actions. These include reduced hepatic release of

glucose and improved sensitivity to Insulin, possibly due to an increase in number of

peripheral Insulin receptors. Sulphonylureas are mainly indicated for Maturity onset

Diabetics of average weight not controlled by diet alone. The contraindication

includes juvenile Diabetes, Ketosis, patients taking Insulin and presence of renal,

hepatic, cardiovascular disease or alcoholic abuse. Hypoglycemia, dyspepsia, skin

rashes, facial flushing after ingestion of alcohol are the most frequently encountered

side effects with sulphonylureas. E.g. Tulbutamide, Chlorpropamide etc.

Biguanides: There major effect is to increase the peripheral uptake of glucose and in

large doses to delay or decrease intestinal absorption. These are the drug of choice for

the treatment of maturity onset obese diabetic patients who have failed to lose weight

on diet. Biguanides are also used in combination with sulphonylureas to enhance the

inadequate or failing effects of the latter. But these affect the gastrointestinal tract

adversely and the incidences of death from lactic acidosis are substantially high. The

adverse effects include metallic taste in mouth, anorexia, nausea, dyspepsia, diarrhea,

malaise, weakness, drowsiness, lactic acidosis and lastly the vitamin B12

malabsorption after prolonged treatment. E.g. Phenformin, Metformin, etc

-80-


ORAL HYPOGLYCEMIC AGENTS:

TableNo.16 Oral Hypoglycemic Agents Drug Action

Agent Mechanism of

Action

Example Anticipated

Reduction

in HbA1C%

Agent Specific

Advantages

Insulin

Secretagogues

Sulfonylureas

Insulin

Glipizide

1-2

Lower fasting

blood glucose

Meglitinide

Repaglinide Short onset of

action,lower PPBG

Biguanides Hepatic glucose

production, ,

glucose utilization

Metformin

1-2

Weight loss,

Improve lipid

profile, No

hypoglycemca

Alpha-

Glucosidase

inhibitors

Delay Glucose

absorption in the Gut

Acarbose

miglitol

0.5-1 No risk of

hypoglycemia

Thizolidinedio

nes

Insulin resistance Rosiglitazone

Proglitazone

1-2 Insulin &

Sulfonylurea

requirements,

triglycerides.

Insulin:

Insulin is indicated for type - I diabetic as well as for type - II diabetic patients with

insulinopenia whose hyperglycemia does not respond to diet therapy either alone or

combined with oral hypoglycemic drugs. Insulin injections are very much necessary

in severs conditions of hyperglycemia. There are various preparation are present

depending upon their purity, solubility and species (like Human/Bovine).

Type of Insulin: Apart from the species difference, seven types of Insulin are

commercially available. They may be divided into Insulin of fast, intermediate and

-81-


long action (Harrison, 1981). They may also be called Soluble Insulin, Protamine

Insulin and Insulin zinc suspension. Highly purified, semi-synthetic human Insulin

offers a safe and effective means to explore the possible advantages of homologous

human Insulin in the management of Diabetes mellitus.

Choice of Insulin: Crystalline Insulin is best for emergencies such as for the

treatment of Diabetic Ketoacidosis. It is also employed for daily use in combination

with intermediate Insulin to bring on earlier action.

Treatment of Chronic Complications:

Multidisciplinary approach is recommended for persons with complications of

diabetes.

To reduce the risk and slow down the progression of nephropathy, glucose control and

blood pressure control should be optimized along with Specific treatment of the

complications such as laser photocoagulation in diabetic retinopathy etc..

Steps in the management of Diabetic Patients:

Diagnostic Examination: All necessary investigations should be done for the

diagnosis including all systemic examinations along with proper history.

Patient Education (Self Management Training): Since diabetes is a life long

disorder, education of the patient and family members is probably the most important

obligation of the physician.

ADVICE:

Check Regular Blood Glucose Level: Self monitoring of blood glucose may be

advice to the patients as it has provided greater flexibility in management while

achieving improved glycemic control.

Diet Control Therapy: Treatment must be individualized on the basis of type of

Diabetes and specific needs of each patient.

-82-


Both modern medicine and ayurveda emphasize the importance of regulation of high

calorie diet and observation of probable mode of exercises.

PATHYA-APATHYA90

Those Aaharas and viharas which are suitable to the disease condition are

called Pathya and those which promote severity of disease are called Apathya. Pathya

is having a key role in the management of Madhumeha. Even in modern science also

Diet & Exercise are included in diabetes management. So before stepping to

management we have to consider for the Pathya-Apathya. Pathya and Apathya Aharas

and Viharas according to different Ayurvedic classics are as follows:

Pathya: 91

(a) Aahara:

Shook Dhanya: Jeerna Shali, Shashtika, Kodrava, Yava, Godhuma, Uddalaka,

Shyamaka

Shimbi Dhanya: Chanaka, Adhaki, Kulattha, Mudga

Shaka Varga: The leafy vegetables with a predominance of tikta-kashaya rasa,

Patola, Karvellaka, Shigru

Phala Varga: Jambu, Dadima, Shringataka, Amalaki, Kapittha, Tinduka, Kharjura,

Kalinga, Navina Mocha.

Mamsa Varga: Vishkira mamsa, Pratuda, Jangala mamsa

Taila Varga: Danti, Ingudi, Sarshapa, Atasi

Udaka Varga: Sarodaka, Kushodaka, Madhudaka

Kritanna Varga: Apupa, Saktu, Yavodana, Vatya, Yusha

Others: Madhu, Hingu, Saindhava, Maricha, Lasuna

-83-


(b) Vihara:

To have walks, travelling on elephants, horses and different plays, different

form of marshal arts, roaming in different places without chappal and umbrella.

Apathya: 92

(a) Ahara: Jala, Milk, Ghee, Oils, Curd, Sugar, Different types of rice preparations,

anupa, gramya and audaka mamsa, Ikshurasa, Pishtanna, Navannan, sauveraka,

suramadya, suktha, Amlarasaahara, sugarcandy juice,.

(b) Vihara: Eksthana asana, Divaswapa, Dhoompana, Sweda, Raktamoksha,

Mutravega dharana.

TREATMENT REGIMENS: MODERN VIEWS.

Diet:

A well-balanced nutritious diet remains a fundamental element of therapy. In

obese patient with mild hyperglycemia the major goal of diet therapy is weight

reduction by caloric restriction. Dietary treatment of Diabetes still constitutes the

basis for management, so that it is believed even today that 50% of diabetics could be

put to control only by judicious dietary regimen. The chief aims of diabetic diet are: 93

a) Achieve good glyceamic control

b) Reduce hyperglyceamia and avoid hypoglyceamiaPrevent hypoglycemia

c) Obtain ideal body weight.

d) Reduce the risk of micro and macrovascular complications.

e) Ensure adequate dietary intake.

Type of Diet: Basically there are two types of diet:

Unmeasured Diets: If Insulin or oral hypoglycemic agents are not required and

marked obesity is not present it may not be necessary for the patient to follow such an

accurate diet.

-84-


Forbidden Foods: Sugar, Jam, Honey, Tinned fruits, Sweets, Chocolates, Glucose

Drinks, Food made with Sugar, Cakes, Sweet Biscuits, Puddings, Rice and alcoholic

drinks.

Foods allowed in moderation: Chapatis made from wheat or millets, peas and backed

beans, breakfast cereals and all fresh and dried fruits, custard.

Free Foods: Eggs (not fried), vegetables such as cabbage, cauliflower, brinjal, lady’s

finger, French beans, cucumber, lettuce, tomato, spring onion, radish, asparagus,

lastly the saccharine for sweetening.

Measured Diet: These are required for patients who are being treated with Insulin or

oral hypoglycemic agents and also for those who are overweight and are on a anti

obese regimen.

NUTRITON: 94

Medical Nutrition Therapy (MNT) is an integral component of Diabetes Management.

Nutritional Recommendations for Diabetics:

Carbohydrate: Whole grains, fruits, vegetables and low fat milk should be included

in the healthy diet. The total amount of carbohydrate in diet is more important than

source or type. As sucrose does not increase glycemia to a greater extent than

isocaloric amounts of starch, sucrose and sucrose containing foods do not need to be

restricted.

Protein: Protein intakes > 20% of total daily energy should be avoided.

Fat: Less than 10% of energy intake should be derived from saturated fats.

Cholesterol: <300 mg/day. Individuals with LDL>100 mg/dl should take cholesterol

<200 mg/day.

-85-


Vitamins and Minerals: As there is no evidence of benefit from it, vitamins and

minerals are not advisable if person do not have underlying deficiencies.

Antioxidant: Routine supplementation of antioxidants is not advised because of

uncertainties related to long term efficacy and safety.

Calorific Requirements: The approximate ratio in normal person’s diet is protein

12%, fat 42% and carbohydrate 46%, but in diabetics it is usually needed to be

modified as protein 15%, fat 35% and Carbohydrate 50%.

In Insulin requiring Diabetics the distribution of calories is very important to

avoid the hypoglycemia. A typical patient of IDDM usually require 20% of total

calories for breakfast, 35% for lunch, 30% for the dinner and 15% for the late evening

feedings. (Harrison 1997)

EXERCISE

Exercise and Type 1 diabetes: The ability to adjust the therapeutic regimen (Insulin

and MNT) to allow safe participation has been recognized as an important

management strategy in these individuals.

The individual with type 1 DM should follow these guidelines:

a. Metabolic control before physical activity.

b. Avoid physical activity if Fasting glucose > 250 mg/dl and ketosis is present.

c. Ingest added carbohydrate if glucose level < 100 mg/dl

d. Blood glucose monitoring before and after physical activity.

e. Food intake – Carbohydrate based foods should be readily available to avoid

hypoglycemia.

Exercise and Type 2 diabetes: The possible benefits of physical activity for the

patient with type 2 diabetes are substantial, and recent studies strengthen the

-86-


importance of long term discrete physical activity programs for the treatment and

prevention of Diabetes mellitus. It reduces the risk of cardiovascular disease,

Hyperlipidemia, Hypertension and Obesity. Recent studies reveal that exercise

increases Adiponectin levels and thus increase Insulin Sensitivity in humans.

DIABETIC QUALITY OF LIFE:

The World Health Organization (WHO) has established two main objectives

in caring for diabetic patients: first, maintain the health and quality of life of

individuals with diabetes through effective patient care and education and second,

treat and prevent complications of the disease which should decrease morbidity and

mortality as well as increase the therapeutic compliance of the patients.

The above elucidated Ayurvedic and Conventional modalities of treatment are

all aimed at bringing about good metabolic control at different levels of normal

physiological process of digestion, but achieving good metabolic control has been

found difficult in children, and particularly in adolescents. Having diabetes requires a

complex, intrusive and highly demanding daily programme for families with one or

more diabetic members in the family, which may have a negative effect on Quality of

Life (QOL). Good Quality of Life is associated with better metabolic control and it is

the subjects general and health related Quality Of Life which is gaining maximum

focus and has become an important outcome in any clinical studies and healthcare

interventions.

The World Health Organization (WHO) defines QOL as an “individual’s perception

of their position in life in the context of the culture and value systems in which they

live and in relation to their goals, expectatctions, standards and concerns. It is a broad

ranging concept, affected in a complex way by the person’s physical health,

-87-


psychological State, personal belief and social relationships to salient features of their

environment”.Other experts suggest that QOL is a multidimensional, subjective and

dynamic concept.

In medical sciences, QOL is used in 2 ways: general QOL or the general feeling of

well-being and health-related QOL, involving health-related problems for different

diseases. A number of questionnaires are available covering both aspects. The one

accepted and validated from the Diabetes control and complications trial – DCCT and

also world health organization approved field test instruments with questionaires can

be used for various clinical study.

The Future of Diabetes:

Scientists are now testing whether giving insulin injections or a pill might keep

people from getting diabetes, at least for a little while. Scientists are convinced that

some day in the future a treatment can be used to vaccinate all children against

Diabetes. Since 1971, scientists have been trying to create an artificial pancreas to try

to cure diabetes in people who clearly have it. With an artificial pancreas, a person

with diabetes could have controlled blood sugars without having to inject insulin. The

artificial pancreas is still years away, but scientists are confident that it is possible.

-88-


DRUG REVIEW

Proper understanding of the characteristic features of the drug is very

important prior to the treatment procedure. This aspect has been well highlighted by

Acharya Charaka,

That drug, its pharmacodynamics and pharmacokinetics mentioned in the

Authentic Vedic Dictionaries – Nighantu, if not well assimilated by the administrating

physician then, it is not too far in bringing about deadly, harmful, severe adverse

events in the subject, just like a dreadful poison, dreadly weapons and a dangerous

lightning flash in bringing about the untowards effect. So, it is mandatory to be well

aware of pharmacological properties and actions of the individual drugs within the

investigational product.

Madhumeha, as already mentioned occur either due to Avaraka doshas like

Kapha and Pita within the Srotas’s thus interfering with the normal pathway of vayu.

So, Samprapti Vighatana forms the basic core for treating this diseased condition. The

Shamana Yoga selected for the present study comprises of seven drugs which are very

easily available and hypothesized to have the ability of breaking the above vicious

cycle of pathology along with Mehagna action synergistically.

VATSAKADI QWATHA110:

The reference for Vatsakadi Qwatha is available in Qwatha Kalpana

Adhyaya of the Sharangadhara Samhita containing Vatsaka, Haritaki, Vibhithaki,

Amalaki, Daruharidra, Musta and Bijaka as the ingredients taken in equal quantities.

The descriptions of these ingredients with regards to their nomenclature,

Chemical Composition, Classical Pharmacological Properties and Actions along with

their Humoral Effects and updated studies related to pre-clinical and clinical

evaluation are enlisted hereafter.

‐ 90‐


TableNo.16 Pharmacodynamic properties of the drugs used in the formulation125

Drug Rasa Guna Virya Vipaka Doshagnata C.C124

1 Vatsaka Tikta

Kashaya

Laghu,

Ruksha

Sheeta Katu Kapha Pitha

Upashoshana

Anthraquinone

glycosides,

Alkaloids,

Flavanoids.

2 Haritaki Lavana

Varjitha

Pancha

Rasa

Laghu,

Ruksha

Ushna Madhura Tridoshagna,

Chakshushya,

Medohara,

Jvara↓

Tannins,

A. glycosides,

Polyphenolic

compounds

3 Vibhitaki Kashaya Laghu,

Ruksha

Ushna Madhura Kaphapithagna

Jvara↓

Tannic acid,

Gallic acid,

Glycosides.

4 Amalaki Lavana

Varjitha

Pancha

Rasa

Laghu,

Ruksha

Sheeta

Madhura

Tridoshagna

Jvara↓

Ascorbic acid

5 Darvi Tikta Laghu,

Ruksha

Ushna Katu? Kaphapithagna

Dosha Pachaka

Alkaloids

6 Musta Kashaya,

Katu,

Tikta

Laghu,

Ruksha

Sheeta Katu Kaphapithagna

Medohara

Trushna↓

Volatile oils

7 Bijaka Kashaya,

Katu,

Tikta

Laghu,

Ruksha

Ushna Katu Kaphapithagna

Medohara

Udarda↓

Tannins.

Bio Flavanoids

‐ 91‐


VATSAKA125

Gana : Arsoghna, Kandughna etc

Family : Apocynaceae.

Latin Name : Holarrhena antidysenterica (Roth) A.DC

Chemical Constituents : Conessine and related alkaloids.

Therapeutic Action : Deepana, Samagrahi, Upashoshaka.

Therapeutic Uses : Pravahika, Atisara, Arsha, Trushna.

Therapeutic Form and Dose: Stem Bark Decoction 20-30ml.

RECENT STUDIES124:

1. Anti-Bacterial activity of Holarrhena antidysenterica against enteric

pathogens118.

2. Anti-Bacterial steroid alkaloids from the stem bark of Holarrhena

antidysenterica119.

3. Anti-Diarrhoeal and Anti-Microbial activity of Holarrhena

antidysenterica119.

4. The in vitro Antioxidant activity and total phenolic content of four Indian

medicinal plants119.

5. Hepatoprotective activity of Holarrhena antidysenterica.

6. Cardioprotective activity of Holarrhena antidysenterica.

7. Anti Inflammatory activity of Holarrhena antidysenterica.

‐ 92‐


HARITAKI125

Gana : Amalakyadi, Haritakyadi, Parushakadi, Trivruthadi,

Prajasthapana, Jvaraghna, Kustaghna.

Family : Combretaceae

Latin Name : Terminalia Chebula. Retz

Chemical Constituents : Tannins – 30% Chebulinic acid, 45% Tannic acid,

Gallic Acid, resins etc, Anthraquinones and

Polyphenolic Compounds.

Therapeutic Action : Sarvadoshaprashamana, Rasayana, Deepana,

Anulomana.

Therapeutic Uses : Vibandha, Aruci, Udavarta, Gulma, Udararoga, Arsha,

Pandu, Shotha, Jeernajvara, Vishamajvara, Prameha,

Shiroroga, Kasa, Tamaka Shwasa, Hrdroga.

Therapeutic Form and Dose: 3-6 g of the drug in Powder form.

RECENT STUDIES124:

1. Anti Mutagenic activity of Terminalia chebula.

2. Cardioprotective activity of Terminalia chebula.

3. Anti hemorrhagic activity of Terminalia chebula.

4. Anti Hyperlipidemic activity of Terminalia chebula.

5. Anti viral activity of Terminalia chebula119.

6. Anti parasitic activity of Terminalia chebula119.

7. Retinoprotective activity of Terminalia chebula.

8. Anti Inflammatory activity of Terminalia chebula.

‐ 93‐


AMALAKI125

Gana : Triphala, Parusakadigana (Susruta),

Vayahsthapana, Virechanopaga (Charaka)

Family : Euphorbiaceae

Latin Name : Emblica officinalis Gaertn.

Syn. Phyllanthus emblica Linn

Chemical Constituents : Vitamin C, Tannin, Gallic acid, Tannic acid.

Therapeutic Action : Tridoshahara, Vrshya, Rasayana, Cakshushya.

Therapeutic Uses : Raktapita, Amlapita, Prameha, Daha

Therapeutic Form and Dose: 3-6 g of the drug in powder form.

RECENT STUDIES124:

1. Nephroprotective activity of Emblica officinalis.

2. Neurotonic effect activity of Emblica officinalis.

3. Anti carcinogenic activity of Emblica officinalis.

4. Anti Hyperlipidemic activity of Emblica officinalis.

5. Anti Ulcerogenic activity of Emblica officinalis119.

6. Anti Oxidant activity of Emblica officinalis119.

7. Anti Inflammatory activity of Emblica officinalis.

8. Anti Hyperglycemic activity of Emblica officinalis.

‐ 94‐


VIBHITAKI125

Gana : Jvarahara, Virechanopaga.

Family : Combretaceae

Latin Name : Terminalia belerica Roxb.

Chemical constituents : Gallic acid, Tannic acid and Glycosides, Fructose,

Galactose, Glucose, Mannitol.

Therapeutic Action : Kaphapitagna, Bhedaka, Krimigna, Cakshushya,

Keshya.

Therapeutic Uses : Svarabheda, Netraroga, Kasa, Chardi, Krimiroga,

Vibandha

Therapeutic Form and Dose: 3-6 g of the drug in Powder form.

RECENT STUDIES124:

1. Retinoprotective activity of Terminalia belerica119.

2. Anti Hyperlipidemic activity of Terminalia belerica.

3. Anti platelet aggregation activity of Terminalia belerica.

4. Anti hyperglycemic activity of Terminalia belerica.

5. Anti inflammatory activity of Terminalia belerica.

‐ 95‐


DARUHARIDRA125

Gana : Arsoghna, Kandugna, Lekhaneeya (Ch);

Haridradi, Musthadi, Lakshadi (Su)

Family : Berberidaceae

Latin Name : Coscinium fenestratum

Chemical constituent : Berberine.

Natural Habitat : SriLanka, Southern belt of Karnataka.

Therapeutic Action : Stanya Shodhana, Stanya Doshahara,

Dosha Pacana

Therapeutic Uses : Amatisara, Medoroga, Urustambha,

Karnaroga, Mukharoga, Netraroga,

Vrana, Meha.

Therapeutic Form and Dose : 5-10 ml of the drug in Qwatha form.

RECENT STUDIES124:

1. Retinoprotective activity of Coscinium fenestratum119.

2. Anti cancer activity of Coscinium fenestratum119.

3. Anti septic activity of Coscinium fenestratum119.

4. Hepatoprotective activity of Coscinium fenestratum119.

5. Nephroprotective activity of Coscinium fenestratum119.

6. Cardiotonic activity of Coscinium fenestratum119.

7. Anti ulcer activity of Coscinium fenestratum119.

8. Anti inflammatory activity of Coscinium fenestratum119.

‐ 96‐


MUSTA125

Gana : Kandugna, Stanya Shodhaka - Charaka

Family : Cyperaceae

Latin Name : Cyperus rotundus.

Chemical constituents : Volatile oils

Therapeutic Action : Pitakaphahara, Sthoulyahara, Shotahara, Deepana,

Pacana, Grahi, Trushnanigrahana, Krimigna, Tvak

doshahara, Jvaragna, Vishaghna

Therapeutic Uses : Agnimandya, Ajirna, Trushna¸ Jvara, Samgrahi¸

Mutrakruchra, Stanyavikara, Sutikaroga, Atisara,

Amavata, Krimiroga.

Therapeutic Form and Dose: 3-6 g (Powder), 20-30 ml (Kwatha)

RECENT STUDIES124:

1. Anti diarrheal activity of Cyperus rotundus119.

2. Anti Hyperlipidemic activity of Cyperus rotundus119.

3. Hepatoprotective activity of Cyperus rotundus119.

4. Anti Bacterial activity of Cyperus rotundus119.

5. Anti Inflammatory activity of Cyperus rotundus119.

6. Anti Oxidant activity of Cyperus rotundus.

‐ 97‐


BIJAKA125

Gana : Udarda Prashamana – Charaka.

Family : Fabaceae

Latin Name : Pterocarpus marsupium Roxb.

Chemical Constituents : Epicatechin, Marsupin, Pterostilbene.

Therapeutic Action : Saraka, Vatartidoshanut, Galadoshaghna, Keshya,

Tvacya, Raktamandalanalanashini, Kaphapitagna

Therapeutic Uses : Pandu, Prameha, Medodosha, Kushta, Krimiroga,

Shvitra, Madhumeha, Sthoulya

Therapeutic Form and Dose: 32-50 g of the drug for decoction

RECENT STUDIES124:

1. Anti Diabetic activity of Pterocarpus marsupium119.

2. Anti Hyperlipidemic activity of Pterocarpus marsupium119.

3. Hepatoprotective activity of Pterocarpus marsupium119.

4. Cardiotonic activity of Pterocarpus marsupium119.

5. Anti inflammatory activity of Pterocarpus marsupium.

6. Anti oxidant activity of Pterocarpus marsupium119.

7. Insulin like activity of Pterocarpus marsupium119.

‐ 98‐

Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)

METHODOLOGY

The process of explaining the unexplained facts on the scientific grounds in a

systemic and orderly manner can be termed as Research and the scientific methods

adopted to explain the unexplained facts can be termed as the Research Methodology.

In the present clinical study, an attempt has been made to explain the Mehagna effect

- Anti hyperglycemic effect of a Polyherbal formulation cited in Ayurvedic classics.

MATERIALS:

For the present clinical study, the Polyherbal formulation selected is

Vatsakadi Qwatha110 mentioned in Sharangadhara Samhita, Madhyama khanda, 2nd

Chapter- Qwatha Kalpana Adhyaya- Mehagna context. The ingredients of the

Polyherbal formulation includes Vatsaka, Haritaki, Amalaki, Vibhitaki, Daruharidra,

Musta and Bijaka.

Method of Preparation of Qwatha110:

The ingredients of Vatsakadi Qwatha were individually taken in the quantity

of 6.5kgs each and made into coarse powder of the seven drugs. To this mixture of

total 45.5kgs drugs 4 times of water, i.e. 182 ltrs were added and is made to boil on

mild fire. It is subjected to fire until it is reduced to 1/4th.The Qwatha thus obtained is

filtered through a Clean Cloth and is collected in a Clean Sterile Container and is

measured to be 45 litres in quantity. It is then preserved by adding required amount of

Methyl Paraben- to the total quantity of the qwatha obtained. The Qwatha thus

prepared is stirred well for uniform dissolution of the preservative and is filled in the

bottles of 500ml capacity and is labeled and sealed appropriately.

‐ 99 ‐


METHODS

SOURCE OF STUDY

a) Literary Source:

All available classical references bearing the description of Madhumeha is

referred to obtain the relevant literary data for the study and also all the available

electronic databases – Pubmed, Webmd and Biomed.

b) Pharmaceutical Source:

The Polyherbal formulation selected for the present work Vatsakadi

Qwatha is prepared in the pharmacy of A.L.N. Rao Memorial Ayurvedic Medical

College as per textual references. It is prepared according to the classical method of

Qwatha Kalpana told by Acharya Sharangadhara110.

c) Clinical Source:

Subjects of either sex diagnosed for Madhumeha on the basis of Classical

Clinical Features are selected from OPD and IPD of A.L.N Rao Ayurveda Medical

College and Hospital, Koppa.

Sampling Method:

Random sampling has been done from the adult population irrespective of sex,

religion and economic status satisfying the inclusion criteria.

Method of Collection of Data:

‐ 100

Based on the classical signs and symptoms of Madhumeha the patients of

either sex between age group of 25-60 yrs are selected from the OPD and IPD of ALN

Rao Memorial Ayurveda College Hospital. Totally 30 members of patients is selected

for study purpose by random sampling method following inclusion and exclusion

criteria. The trial group has been given Vatsakadi Qwatha 50ml twice daily before

food in divided doses. The duration of the treatment is 45 days. For the purpose of

‐


assessment, scoring has been given to all signs and symptoms from grade 0-3

according to severity and is documented appropriately before the treatment, after 15

days, 30 days and 45 days of the treatment and 90 days of follow up without

medication with an interval of 15 days. Statistical analysis is done by using paired

Student‘t’ test.

A) Inclusion Criteria123:

1. The patients with Prabhutamutrata, Avilamutrata, along with other signs and

symptoms like Pipasa Adhikata, Kshudha Adhikata, Karapada Daha, Karapada

Suptata, Swedapravruthi and Dourbalya is included for the present study.

2. Age group between 25123-60yrs of either sex is included for the present study.

3. The diabetic patients with Fasting Blood Sugar Level ranging from 126mg/dL-180

mg/dL and Post Prandial Blood Sugar level ranging from 160mg/dl - 250mg/dl is

included for the present study.

B) Exclusion Criteria123:

1. Age group > 60 yrs and < 25 yrs are excluded.

2. Fasting Blood Sugar Level < 126 mg/dl, Post Prandial Blood Sugar Level <140

mg/dl.

3. Patients suffering with systemic disorders like Renal Disorder, Cardiac disorder

etc.

4. Sahaja and Jathaja Madhumeha w.s.r to MODY and Gestational diabetes123.

5. Patient with diabetic gangrene, carbuncles and other diabetic complications.

DIAGNOSTIC CRITERIA123:

Patients were diagnosed on the basis of signs and symptoms related to

Madhumeha laid down in Ayurvedic Classics and Essential Laboratory Findings

explained for Diabetes Mellitus. They are given as follows.

‐ 101 ‐


1. Prabhutamutrata 7. Karapada Suptata.

2. Avilamutrata 8. Dourbalya.

3. Pipasa Adhikata. 9. FBS ≥126mg/dl- 180mg/dl.

4. Kshudha Adhikata. 10. PPBS ≥200mg/dl-250mg/dl.

5. Swedapravruthi. 11. HBA1C

6. Karapada Daha 12. FUS and PPUS.

STUDY DESIGN:

Standardized Single Blind Clinical Study, done for a group of 20 subjects.

TableNo.17 Treatment Schedule

Sample size 20 patients

Medicine Vatsakadi Qwatha

Dose 50ml twice daily before

food in divided doses

Duration 45 days.

FOLLOW UP: The follow up of the study had been done for 90 days without

medication.

LABORATORY INVESTIGATIONS

FBS- Fasting Blood Sugar

PPBS- Post Prandial Blood Sugar.

FUS – Fasting Urine Sugar.

PPUS - Post Prandial Urine Sugar.

‐ 102

HBA1c –Glycated/ Glycosalated Hemoglobin

‐


Diabetic Quality Of Life – Questionaire**

Quality of life has gained maximum focus in the recent days especially in the disease

Diabetes Mellitus and has become an important outcome in any clinical trial and

healthcare interventions. So here an attempt will be made for assessing the Diabetic

Quality Of Life (DQOL) by selecting few relevant Questions from DCCT and

WHOQOL approved and validated Diabetic Quality Of Life – DQOL Questionaire

and Scoring. These Questions related will be assessed before and after the treatment

accordingly.

‐ 103

Sl no. QUESTIONS SCORING I. PHYSICAL 1. How often do you feel physically ill? 1 2 3 4 5

2. How often do you have bad night sleeps? 1 2 3 4 5

3. To what extent do you have difficulty in performing your routine activities?

1 2 3 4 5

4. How much are you bothered by any limitations in performing everyday living activities?

1 2 3 4 5

5. How often do you feel fatigue? 1 2 3 4 5

II. PSYCHOSOCIAL 1. How satisfied are you with your social relationship? 1 2 3 4 5

2. How often do you feel good about yourself? 1 2 3 4 5

3. Do you get the kind of support from others that you need?

1 2 3 4 5

4. How much do you experience positive feelings in your life?

1 2 3 4 5

5. How well are you able to concentrate? 1 2 3 4 5

III. SEXUAL 1. How often does your diabetes interfere with your sex

life? 1 2 3 4 5

2. How satisfied are you with your sex life? 1 2 3 4 5

‐


3. How often are you worried about your sexual life? 1 2 3 4 5

4. Are you bothered by any difficulties in your sex life? 1 2 3 4 5

5. How well are your sexual needs fulfilled? 1 2 3 4 5

IV. SATISFACTION IN LIFE 1. How satisfied are you with the quality of your life? 1 2 3 4 5

2. How much do difficulties with transport restrict your life?

1 2 3 4 5

3. To what extent are you hopeful about your life? 1 2 3 4 5

4. To what extent do you feel peaceful within yourself? 1 2 3 4 5

5. To what extent does faith contribute to your well-being? 1 2 3 4 5

V. TREATMENT SATISFACTION 1. How willing are you to take medications? 1 2 3 4 5

2. How much do you need any medication to function in your daily life?

1 2 3 4 5

3. How dependent are you on medications? 1 2 3 4 5

4. How satisfied are you about the present treatment? 1 2 3 4 5

5. How confident are you with the outcome of the treatment?

1 2 3 4 5

HEALTH PERCEPTION*

1. Compared to others of your age would you say your health is

E G F P VP

**SOURCE - WHOQOL - SRPB field test instrument and DCCT approved and

validated Questionaire.

*Health Perception – E- excellent, G- good, F – fair, P- poor, VP-Very poor.

‐ 104 ‐


CRITERIA FOR ASSESSMENT OF RESULTS WITH GRADING OF PARAMETERS

Table No.18 ASSESSMENT CRITERIA AND GRADING OF THE RESULTS

SUBJECTIVE PARAMETERS SL

NO: PARAMETER ASSESMENT RANGE SCORE

Prabhuta Mutrata(Polyuria) Amount of Urine: a) Normal 500ml-2500ml 0 b) Slightly increased 2500ml-3000ml 1 c) Increased 3000ml- 3500ml 2 d)Markedly Increased

>3500ml 3

Frequency of Urination: a) Normal 3-5 times /day & 0-1 times/ night 0 b) Slightly increased 6-8 times/ day & 1-2 times/ night 1 c) Increased 6-8 times/ day & 3-4 times/ night 2

1.

d)Markedly Increased

>8 times/ day & > 5 times/ night 3

2. Avilamutrata a) Normal a)Clearly readable letters 0 b) slightly increased b)Readable letters 1 c) Increased c)Can read with difficulty 2 d)Markedly

Increased d)Cannot read the letters 3

3. Pipasa Adhikata a) Normal 1.5-2 ltrs/day intake of water 0 b) Slightly increased 2-3 ltrs/day intake of water 1 c) Increased 3-4 ltrs/day intake of water 2 d)Markedly

Increased >4 litters intake of water 3

4. Kshudha Adhikata a) Normal Taking food 2-3 times a day 0 b) Slightly increased Taking food 4-5 times a day 1 c) Increased Taking food 6-7 times a day 2 d)Markedly

Increased Taking food >8 times a day 3

5. Swedapravruthi a) Normal Normal sweating by doing normal physical

exercise(daily work) 0

b) Slightly increased excessive sweating by doing normal physical exercise(daily work)

1

‐ 105 ‐


‐ 106

c) Increased excessive sweating even by walking some distance or stepping a ladder (even by mild daily work)

2


Excessive sweating even at rest also. 3

6. Karapada Daha a) Normal Absent 0 b) Slightly increased occasionally mildly present 1 c) Increased constantly mildly present 2 d)Markedly

Increased severely present 3

7. Karapada Suptata a) Normal Absent 0 b) Slightly increased occasionally mildly present 1 c) Increased constantly mildly present 2 d)Markedly

Increased severely present 3

8. Dourbalya a) Normal can do normal physical exercise(daily work )

without any difficulty 0

b) Slightly increased can do normal physical exercise(daily work )with some difficulty

1

c) Increased can do normal physical exercise(daily work )with much difficulty

2


Cannot do daily activities 3

OBJECTIVE PARAMETERS 9 Blood Sugar FASTING BLOOD SUGAR a) Normal 80-126mg/dl 0 b) Slightly increased 126-150mg/dl 1 c) Increased 150-180mg/dl 2 d)Markedly

Increased >180mg/dl 3

10 POST PRANDIAL BLOOD SUGAR

a) Normal 126-160mg/dl 0 b) Slightly increased 161-190mg/dl 1 c) Increased 190-220mg/dl 2 d)Markedly

Increased 221-250mg/dl 3

11 FASTING URINE SUGAR Normal Absence of glucose in urine (No ppt) 0

‐


Slightly increased Presence of 0.5% of glucose in urine (Green ppt)

1

Increased Presence of 1 % of glucose in urine (Yellow ppt)

2

Markedly Increased Presence of 1.5% of glucose in urine (Orange ppt)

3

12 POST PRANDIAL URINE SUGAR

Normal Absence of glucose in urine (No ppt) 0 Slightly increased Presence of 0.5% of glucose in urine (Green

ppt) 1

Increased Presence of 1 % of glucose in urine (Yellow ppt)

2

Markedly Increased Presence of 1.5% of glucose in urine (Orange ppt)

3

13 GLYCATED / GLYCOSALATED HEMOGLOBIN – HBA1C Normal <8% 0 Good control 8-9% 1 Fair control 9-10% 2 Poor control >10% 3 12 DIABETIC QUALITY OF LIFE

Not at all 1 A little 2 Moderate amount 3 Very much 4 Extreme amount 5

OVERALL ASSESSMENT CRITERIA

The overall effect of the therapy was assessed as stated below.

1. A patient in whom there was reduction in the assessment criteria to grade 0 against

the initial severity scoring is considered as 90%-100% response. It is considered as

good response.

2. Patient in whom there was reduction in 2 levels of the assessment criteria against the

initial severity scoring is taken as 60%-90% response. It is taken as marked response.

3. Patient in whom there was reduction in one level of the assessment criteria against the

initial severity scoring is taken as 30%-60% response. It is taken as mild response.

‐ 107 ‐


4. Patients in whom assessment criteria remained same against the initial severity

scoring is taken as 0-30% response and is considered as poor response.

OVERALL ASSESSMENT CRITERIA

Table No. 19 Overall Assessment Criteria

Percentage of cure Interpretation

76-100% Good Response

50-75% Moderate Response

26-49% Mild Response

0- 25% Poor Response

STATISTICAL ANALYSIS:

Here the effect of drug administration has been critically analyzed by the

statistical data. Descriptive Statistical Data which includes Mean, Standard Deviation

(S.D), Standard Error (S.E), t- value and P- value were calculated for all the variables.

Post-therapeutic effect of the administered drug is assessed by paired student‘t’ test.

For all the tests, a ‘P’ value of < 0.05 is considered as the statistical significance level

for obtaining accurate result.

‐ 108 ‐


‐ 110‐

OBSERVATION

In this present clinical study, 30 subjects were enrolled. Among the 30

subjects enrolled, 5 subjects were excluded from the study based on the exclusion

criteria. Among rest of 25 subjects who fulfilled the inclusion criteria were taken for

the study, out of which 5 subjects were discontinued during various stages of the

treatment. Finally only 20 subjects who completed the full course of treatment with

follow up observation were taken for observation and statistical analysis. Following

pages contain the descriptive observational analysis of the subjects. These

observations are compiled under the following heading.

A. Demographic Data of the Study.

B. Clinical Data of the Study.

C. Data related to the Diabetic Quality Of Life.

D. Data Related to Results of the Study.

A. DEMOGRAPHIC DATA

1. Data showing Agewise Distribution of the 20 subjects.

Table No: 20 Agewise Distribution of the 20 subjects.

AGE RANGE No. OF SUBJECTS PERCENTAGE

25-30 00 0%

31-35 01 05%

36-40 04 20%

41-45 07 35%

46-50 00 00%

51-55 04 20%

56-60 04 20%


Majority of the subjects were between the age range 41-45 i.e about 07

subjects among the 20 subjects accounting for 35% of the total observation. Between

the age ranges 36-40, 51-55 and 56-60; about 04 subjects in each ranges accounting

for 20% in each of the total observation were observed. Only one subject was found

between the age group of 31-35, which accounts for about 5% of the total observation.

Chart No: 4 Agewise Distribution Chart No: 5 Sexwise Distribution

2. Data Showing Sexwise Distribution of the 20 Subjects.

Table No: 21 Sexwise Distribution of the 20 subjects.

Sex Number Percentage

Males 05 25%

Females 15 75%

Majority of the subjects were female’s i.e about 15 subjects among the 20

subjects taken for the study accounting for about 75% of the total observation.

Remaining 05 subjects were male, accounting for about 25% of the total observation.

‐ 111‐


3. Data of Religoinwise Distribution of 20 subjects.

Table No: 22 Religoinwise Distribution of 20 subjects.

RELIGION NUMBER PERCENTAGE

Hindu 14 70%

Muslim 06 30%

In the present study, 70% i.e about 14 of the 20 subjects were Hindus and

remaining 15% i.e about 06 subjects were Muslims.

Chart No: 6 Religoinwise Chart No: 7 Educationwise

Distribution Distribution

4. Distribution of Educational Qualifications of the 20 subjects.

Table No: 23 Educationwise Distributions of the 20 Subjects.

EDUCATION NO OF SUBJECTS PERCENTAGE

Primary level 03 15%

Secondary level 04 20%

High school level 04 20%

Graduate level 07 35%

Illiterate 02 10%

It is observed that 35% of the total observation i.e 8 subjects of the 20 subjects

had the education at Graduate Level, 20% each i.e 4 subjects each from the 20

subjects were educated to the level of Secondary and High School Level, 15% i.e 03

‐ 112‐


subjects of the 20 subjects were educated to the Primary Level and remaining 10% i.e

02 subjects of the 20 subjects were Illiterates.

Chart No: 8 Marital Statuswise Chart No: 9 Occupationwise

5. Data of Marital Statuswise Distributions of the 20 Subjects.

Table No: 24 Marital Statuswise Distributions of the 20 Subjects.

MARITAL STATUS NO OF SUBJECTS PERCENTAGE

Married 17 85%

Single 03 15%

In the present study, 85% i.e 17 of the 20 subjects were Married and

remaining 15% i.e 03 subjects were unmarried or single.

6. Data related to Occupationwise Distribution of the 20 Subjects.

In the present study, 55% i.e 11 subjects were homemakers, 20% i.e 04

subjects were teachers, 10% i.e 02 subjects were officials and remaining were equally

distributed with 5% i.e 01 subjects each were Watchman, Attender, and Engineer

respectively.

‐ 113‐


Table No: 25 Occupationwise Distributions.

OCCUPATION NO OF SUBJECTS PERCENTAGE

Homemaker 11 55%

Teacher 04 20%

Officer 02 10%

Watchman 01 5%

Attender 01 5%

Engineer 01 5%

7. Data related to habitat distributions of the 20 subjects.

Table No: 26 Percentage of distribution of Habitat.

HABITAT NO OF SUBJECTS PERCENTAGE

Urban 08 40

Rural 12 60

In the present study, 60% i.e 12 subjects of the 20 subjects were among Rural

population and remaining 40% i.e 08 subjects were among Urban population.

Chart No: 10 Habitatwise. Chart No: 11 Socioeconomic Statuses.

‐ 114‐


8. Data Related to the Socio Economic Status of the 20 Subjects.

Table No: 27 Distribution of Socio economic Status of the 20 Subjects.

SOCIOECONOMIC STATUS NO OF SUBJECTS PERCENTAGE

Higher income group 01 5%

Middle income group 14 70%

Low income group 05 25%

In the present study, 70% i.e 14 subjects of the 20 subjects were from Middle

Income Group, 25% i.e 05 subjects were from Low Income Group and remaining 5%

i.e one subject was from High Income Group.

9. Distribution of Desapradhanatha

Table No: 28 Distribution of Desapradhanatha

DESA NUMBER PERCENTAGE

Sadharana 4 20

Anupa 16 80%

In the present study, 80% i.e 16 subjects of the 20 subjects were residing in

Jangaladesa and remaining 20% i.e 04 subjects were residing in Sadharanadesha.

Chart No: 12 Percentage of Desapradhanatha

‐ 115‐


B.SUBJECT’S CLINICAL DATA

1. Data Related to Chief Complaints.

Table No: 29 Data Related to Chief Complaints.

CHIEF COMPLAINTS NO. OF SUBJECTS PERCENTAGE

Frequency 16 80% Prabhutmutrata

Amount 16 80%

Avila Mutrata 20 100%

Pipasa Adhikata 14 70%

Kshudha Adhikata 10 50%

Sweda Pravruthi Adhikata 17 85%

Karapadathaladaha 19 95%

Karapadathalasupti 17 85%

Dourbalya 20 100%

In the present study, 100% i.e 20 out of 20 subjects had Avila Mutrata (AM)

and Dourbalya (D), 95% i.e 19 out of 20 subjects had Karapadadaha (KD), 85% i.e 17

out of 20 subjects had Sweda Pravruthi Adhikata (SP) and Karapadasupti (KS), 80%

i.e 16 out of 20 subjects had Prabhutamutrata (PM), 70% i.e 14 out of 20 subjects had

Pipasa Adhikata (PA) and 50 % i.e 10 out of 20 subjects had Kshudha Adhikata (KA)

as their Chief Complaints.

‐ 116‐


2. Data Related to the History of Present Illness: In the present study, it was found that 45% i.e 9 out of 20 subjects were

accidentally diagnosed with the complaint of Pruritis vulvae while remaining 55%

were diagnosed with the classical symptoms of Madhumeha.

3. Data Related to the History of Past Illness:

In the present study, it was found that 40% i.e 8 out of 20 subjects were having

the previous history of cold, cough and fever in common

4. Data related to Family History.

Table No: 30 Data related to Family History.

FAMILY HISTORY NO OF SUBJECTS PERCENTAGE

Present 00 0%

Absent 20 100%

In the present study, 100% i.e 20 out of 20 subjects showed no family history.

Chart No: 14 Data on Family History Chart No: 15 Data on Diet

‐ 117‐


‐ 118‐

5. Data related to Personal History:

a) Data related to Dietary regimen.

Table No: 31 Data related to Dietary regimen.

Dietary Regimen No of subjects Percentage

Untimely Vegetarian 11 55%

Untimely Mixed 9 45%

In the present study, 55% i.e 11 out of 20 subjects were having Untimely

Vegetarian Dietary Regimen and remaining 45% i.e 9 out of 20 subjects were

observed to have Untimely Mixed Dietary Regimen.

b) Data related to Supplementary Diet

Table No: 32 Data related to Supplementary Diet

Supplementary diet No of subjects Percentage

Tea 8 40%

Coffee 10 50%

Milk 2 10%

Cool drinks 3 15%

Junks/Chats 10 50%

In the present study, 8 subjects i.e 40% had the habit of taking tea, 10

subjects i.e 50% had the habit of taking coffee, 2 subjects i.e 10% had the habit of

taking milk, 3 subjects i.e 15% had the habit of taking cool drinks and 10 subjects i.e

50% had the habit of taking junks / chats.


Chart no.16 Data on Supplementary Diet Chart no.17 Data on Nidra

c) Data related to Nidra

Table No: 32 Data related to Nidra

Nidra No of subjects Percentage

Disturbed 10 50%

Undisturbed 10 50%

In the present study, 10 of 20 subjects i.e 50% had disturbed sleep and

another 10 of 20 subjects i.e 50% had undisturbed sleep.

4. Data related to General Examination:

a) Data related to Body Mass Index

Table No: 32 Data related to Body Mass Index

BMI No of subjects Percentage

19-23 ( Normal) 17 85%

23-27(Over Weight) 02 10%

27-31(Obese) 01 05%

31-35(Very Obese) 00 0%

In the present study, 85% i.e 17 out of 20 subjects were observed to have

normal body mass index while 10% i.e 2 subjects were observed to fall under over

weight and only 05% i.e one out of 20 subjects was observed to fall under the obese.

‐ 119‐


Chart no.18 Data related to BMI Chart no.19 Data on Blood Pressure

b) Data Related To Blood Pressure:

Table no.33 Data Related To Blood Pressure

BLOOD PRESSURE NO. of

SUBJECTS PERCENTAGE

110/70 mm of Hg 07 35%

120/80 mm of Hg 07 35%

130/90 mm of Hg 06 30%

In the present study, 35% i.e 07 out of 20 subjects were observed to

have shared equally with 110/70 mm of Hg and 120/80 mm of Hg, while 30% i.e 06

subjects out of 20 subjects were observed to 130/90 mm of Hg.

c) Data Related To the Mean Biochemical Values

Table No: 38 Data related Mean Biochemical Values

Biochemical tests Mean values

FBS 176mg/dl

PPBS 226mg/dl

HBA1C 8.2%

‐ 120‐


‐ 121‐

5. Data related to Ashtasthana Pareeksha:

a) Data related to Nadi

Table No: 38 Data related to Nadi

Nadi No of subjects Percentage

Vatapitaja 10 50%

Drutha 07 35%

Manda 4 20%

In the present study, Sadharana nadi was observed for 50% i.e in 10 subjects.

Drutha was observed for 35% i.e 07 subjects out of 20 and finally Manda nadi was

observed for 20% i.e. 04 subjects out of 20 subjects.

b) Data related to Mutra:

In the present study, 80% i.e 16 subjects of the 20 subjects were observed

to have Prabhootamootrata and 100% i.e 20 subjects out of 20 subjects were observed

to have Avilamutrata and there was no burning Micturition and other systemic related

Clinical features but it was also observed that 05 subjects out of 20 subjects who had

Avilamutrata had sticky and foul odour and remaining 16 subjects were observed to

have aggravated Pruritis vulvae especially after micturition.

c) Data related to Mala:


to have irregular bowel habit with easy evacuation but, remaining 20% i.e 04 out of

20 subjects were observed to have irregular bowel habit with difficulty in evacuation

and hard stools.


‐ 122‐

d) Data related to Jihwa:


to have dryness of the tongue along with 45% i.e 09 subjects out of 20 subjects were

observed to have whitish coating over the tongue.

e) Data related to Sabda:

No abnormalities in the Sabda have been observed in any subject.

f) Data related to Sparsa:

Table No: 39 Data related to Sparsa:

Sparsa No of subjects Percentage

Ushna 16 80%

Sheeta 04 20%

g) Data related to Druk:

In the present study, none of the subjects were observed to have pallor and

other visual defects.

h) Data related to Akruthi:

Table No: 40 Data related to Akruthi:

AKRUTHI No of SUBJECTS PERCENTAGE

Pravaram 02 10%

Madhyamam 18 90%

Avaram 00 00%

In the present study, 18 subjects i.e 90% showed Madhyama Akruthi and only 2

subjects i.e 10% showed Pravara Akruthi.


‐ 123‐

6) Data related to Dasavidha Pareeksha:

a) Data related to Prakruthi

Table No: 41 Data related to Prakruthi

Prakruthi No of subjects Percentage

Pithakapha 01 05%

Kaphavata 02 10%

Vatapita 05 25%

Kaphapita 05 25%

Vatakapha 07 35%

Pitavata 00 00%

In the present study, Pitakapha was observed in 05% i.e 01 out of 20 subjects,

Kaphavata was observed in 10% i.e 02 out of 20 subjects, Vatapita was observed in

25% i.e 05 out of 20 subjects, Kaphapita was observed in 25% i.e 05 out of 20

subjects, Vatakapha was observed in 35% i.e 07 out of 20 subjects, Pitavata were

observed nil among the 20 subjects.

b) Data related to Vikruthi:

Table No: 42 Data related to Vikruthi:

Vikruthi involved No of subjects Percentage

Rasa 20 100%

Medas 20 100%

Raktha 17 85%

Mamsa 18 90%

Majja 10 50%

Sukra 09 45%

Kleda 20 100%

Lasika 20 100%

Oja 10 50%


‐ 124‐

In the present study, Rasa, Medas, Kleda and Lasika dushti was observed in

100% of the subjects. Majja and Ojo dushti was observed in 50% of the subjects.

Raktha Dushti was observed in 85% of subjects. Mamsa Dushti was observed in 90%

of the subjects and Shukra Dushti was observed in 45% of the subjects.

c) Data related to Satvataha:

In the present study, 85% i.e 17 subjects out of 20 were observed to have

Madhyama Satva and 15% i.e 03 subjects out of 20 were observed to have Avara

Satva.

d) Data related to Satmyatha:

In the present study, 80% i.e 16 subjects out of 20 were observed to have

Madhyama Satmyata and 20% i.e 04 subjects out of 20 were observed to have Avara

Satmyata.

e) Data related to Ahara Shakthitaha:

In the present study, 50% of the subjects were observed to have Madhyama

Ahara shakti while remaining 50% were observed for Pravara Ahara shakti.

f) Data related to Vyayama Shakthitaha:

Table No: 43 Data related to Vyayama Shakthitaha:

Vyayamasakthi Number of subjects. Percentage

Pravaram 02 10%

Madhyamam 16 80%

Avaram 02 10%

In the present study only 2 subjects each showed Pravara and Avara vyayama

shakti while remaining dominated with Madhyama vyayama shakti i.e 16 subjects


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g) Data related to Vaya

Table No: 44 Data related to Vaya:

Age No of subjects Percentage

Balyavastha 00 00

Madhyamavastha 16 80%

Vrudhavastha 04 20%

In the present study 80% i.e 16 subjects out of 20 were observed to be in

Madhyamavastha and 20% i.e 04 subjects out of 20 were observed to be in

Vrudhavastha.

7). Data related to Nidana:

Table No: 45 Data related to Nidana:

Nidana No of subjects Percentage

Asyasukham 20 100%

Swapnasukham 20 100%

Carbohydrate rich diet 20 100%

Fat rich diet 20 100%

Manasika Nidana 20 100%

Lack of exercise 20 100%

In the present study, Asyasukham- in terms of taking excessive sweet and its

by products, Swapnasukham – in terms of sedentary lifestyles, intake of carbohydrate

- Rice, Jaggery and Grains, while fat rich dietary items like curd, butter and non

vegetarian food items was observed in all the subjects.

It was also observed for vihara like sedentary sitting and sexual habits along

with lack of exercise in 100% i.e 20 subjects out of 20 subjects. Chinta

shokadodvegadi Manasika Nidana was also observed in 100% i.e 20 subjects out of

20 subjects.


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9) Data related to Purvarupa:

Table No: 47 Data related to Purvarupa:

Purvarupa No of subjects Percentage

Karapadathaladaha 19 95%

Pipasa 17 85%

Dantamalam 18 90%

Nayanamalam 08 40%

Karnamalam 02 10%

Alasyam 19 95%

Shareera Dourgandhyam 12 60%

Athitandra 15 75%

Athinidra 15 75%

Karapadathalasupti 15 75%

Kesheshu Jatilibhava 02 10%

Asyamadhuryam 02 10%

In the present study, Karapadadaha and Alasya was observed as a purvarupa

for 19 subjects (95%), Dantamalam for 18 subjects (90%), Pipasa for 17% (85%),

Athinidra, Athitandra and Karapadatala Supti for 15 subjects (75%), Nayanamalam

for 08 subjects (40%), Shareera Dourgandhyam for 12 subjects (60%), Kesheshu

Jatilibhava and Asyamadhuryam was observed in 02 subjects (10%).

10) Data Related To Upashaya:

Table no. Data Related To Upashaya

Upashaya No of subjects Percentage

Nimba Patra 20 100%

Guduchi Patra 20 100%

Menthe Powder 20 100%

Walking 19 100%

Exercise 19 100%

Yoga 02 10%


11) Data Related To Sroto Dushti:

Table no. Data Related To Sroto Dushti

Sroto dushti No of subjects Percentage

Rasavaha 20 100%

Raktavaha 19 95%

Medovaha 18 90%

Udakavaha 14 70%

Annavaha 10 50%

Mutravaha 16 80%

C. Data Related To Diabetic Quality Of Life:

Table no. Data Related To Diabetic Quality Of Life

Questions Affected No of subjects Percentage

Physical 20 100%

Psychosocial 10 50%

Sexual 18 90%

Life satisfaction 14 70%

Treatment satisfaction 10 50%

Health perception 16 80%

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RESULTS

EFFECT OF VATSAKADI QWATHAON MADHUMEHA

The Statistical analysis over the effect of Vatsakadi Qwatha after 15,30,and 45

days of treatment period and 90 days of follow-up period are hereby calculated using

paired Student‘t’ test. The statistical analytical reports are as follows,

Effect of Vatsakadi Qwatha on Subjective Parameters

1. Effect of Vatsakadi Qwatha on Prabhutamutrata (Increased amount of

urination)

Table No: 48 Effect of Vatsakadi Qwatha on Prabhutamutrata (Increased

amount of urination)

Mean No Data

BT AT % S.D S.E T P

1. AT 15 days 1.60 1.30 18.75 0.22 0.10 2.78 <0.02

2. AT 30 days 1.60 0.90 41.92 0.22 0.10 6.48 <0.001

3. AT 45 days 1.60 0.60 61.29 0.57 0.17 5.45 <0.001

4. AFU-90 days 1.60 0.90 38.70 0.46 0.15 3.84 <0.01

Vatsakadi Qwatha provided mild significant (P<0.02) relief by 18.75% in the

symptom Prabhuta mutrata (amount of urine) after 15 days of treatment. Vatsakadi

Qwatha provided highly significant (P<0.001) relief by 41.92% in the symptom

Prabhuta mutrata (amount of urine) after 30 days of treatment. Vatsakadi Qwatha

provided highly significant (P<0.001) relief by 61.29% in the symptom Prabhuta

mutrata (amount of urine) after 45 days of treatment. Vatsakadi Qwatha provided

moderately significant (P<0.01) relief by 38.70% in the symptom Prabhuta mutrata

(amount of urine) after 90 days follow-up period.

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2. Effect of Vatsakadi Qwatha on Prabhutamutrata (Increased frequency of

urination)

Table No: 49 Effect of Vatsakadi Qwatha on Prabhutamutrata (Increased

frequency of urination)

Mean No. Data

BT AT % S.D S.E T P

1. AT 15 days 1.70 1.35 20.58 0.23 0.11 3.13 <0.02

2. AT 30 days 1.70 0.95 44.11 0.19 0.10 7.35 <0.001

3. AT 45 days 1.70 0.40 76.47 0.64 0.18 7.07 <0.001

4. AFU-90 days 1.70 1.05 38.82 0.55 0.17 3.80 <0.01


symptom Prabhuta mutrata (frequency) after 15 days of treatment. Vatsakadi Qwatha

provided highly significant (P<0.001) relief by 44.11% in the symptom Prabhuta

mutrata (frequency) after 30 days of treatment. Vatsakadi Qwatha provided highly

significant (P<0.001) relief by 76.47% in the symptom Prabhuta mutrata (frequency)

after 45 days of treatment. Vatsakadi Qwatha provided moderately significant

(P<0.01) relief by 38.82% in the symptom Prabhuta mutrata (frequency) after 90 days

follow-up period.

3. Effect of Vatsakadi Qwatha on Avila Mutrata

Table No: 50 Effect Of Vatsakadi Qwatha on Avila Mutrata

Mean No. Data

BT AT % S.D S.E T P

1. AT 15 days 1.80 1.50 16.66 0.22 0.10 2.78 <0.02

2. AT 30 days 1.80 0.95 47.22 0.55 0.17 4.97 <0.001

3. AT 45 days 1.80 0.50 72.22 0.43 0.15 8.62 <0.001

4. AFU-90 days 1.80 1.30 27.77 0.26 0.11 4.24 <0.001

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symptom Avila mutrata after 15 days of treatment. Vatsakadi Qwatha provided

highly significant (P<0.001) relief by 47.22% in the symptom Avila mutrata after 30

days of treatment. Vatsakadi Qwatha provided highly significant (P<0.001) relief by

72.22% in the symptom Avila mutrata after 45 days of treatment. Vatsakadi Qwatha

provided highly significant (P<0.001) relief by 27.77% in the symptom Avila mutrata

after 90 days follow-up period.

4. Effect of Vatsakadi Qwatha on Pipasa Adhikata

Table No: 51 Effect Of Vatsakadi Qwatha on Pipasa Adhikata

Mean No. Data

BT AT % S.D S.E T P

1. AT 15 days 1.05 0.80 23.08 0.40 0.14 1.70 <0.05

2. AT 30 days 1.05 0.35 66.06 0.85 0.21 3.30 <0.01

3. AT 45 days 1.05 0.30 71.42 0.72 0.19 3.84 <0.01

4. AFU-90 days 1.05 0.45 57.14 0.67 0.18 3.18 <0.01

Vatsakadi Qwatha provided significant (P<0.05) relief by 23.08% in the

symptom Pipasa Adhikata after 15 days of treatment. Vatsakadi Qwatha provided

moderately significant (P<0.01) relief by 66.06% in the symptom Pipasa Adhikata

after 30 days of treatment. Vatsakadi Qwatha provided moderately significant

(P<0.01) relief by 71.42% in the symptom Pipasa Adhikata after 45 days of treatment.

Vatsakadi Qwatha provided moderately significant (P<0.01) relief by 27.77% in the

symptom Pipasa Adhikata after 90 days follow-up period.

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5. Effect of Vatsakadi Qwatha on Kshudha Adhikata

Table No: 52 Effect of Vatsakadi Qwatha on Kshudha Adhikata

Mean No. Data

BT AT % S.D S.E T P

1. AT 15 days 0.70 0.50 28.57 0.16 0.09 2.12 <0.05

2. AT 30 days 0.70 0.25 64.28 0.47 0.15 2.85 <0.02

3. AT 45 days 0.70 0.25 85.71 0.46 0.15 3.84 <0.01

4. AFU-90 days 0.70 0.30 57.14 0.35 0.13 2.91 <0.01


symptom Kshudha Adhikata after 15 days of treatment. Vatsakadi Qwatha provided

mild significant (P<0.02) relief by 64.28% in the symptom Kshudha Adhikata after 30

days of treatment. Vatsakadi Qwatha provided moderately significant (P<0.01) relief

by 85.71% in the symptom Kshudha Adhikata after 45 days of treatment. Vatsakadi

Qwatha provided moderately significant (P<0.01) relief by 57.14% in the symptom

Kshudha Adhikata after 90 days follow-up period.

6. Effect of Vatsakadi Qwatha on Sweda-Pravruthi

Table No: 53 Effect of Vatsakadi Qwatha on Sweda Pravruthi

Mean No. Data

BT AT % S.D S.E T P

1. AT 15 days 1.30 1.20 7.69 0.094 0.07 1.41 <0.05

2. AT 30 days 1.30 0.70 46.15 0.35 0.13 4.37 <0.001

3. AT 45 days 1.30 0.45 66.38 0.66 0.18 4.55 <0.001

4. AFU-90 days 1.30 0.60 53.84 0.32 0.13 5.34 <0.001

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symptom Sweda Pravruthi after 15 days of treatment. Vatsakadi Qwatha provided

highly significant (P<0.001) relief by 46.15% in the symptom Sweda Pravruthi after

30 days of treatment. Vatsakadi Qwatha provided highly significant (P<0.001) relief

by 85.71% in the symptom Sweda Pravruthi after 45 days of treatment. Vatsakadi


Sweda Pravruthi after 90 days follow-up period.

7. Effect of Vatsakadi Qwatha on Karapada Daha

Table No: 54 Effect of Vatsakadi Qwatha on Karapada Daha

Mean No. Data

BT AT % S.D S.E T P

1. AT 15 days 1.40 1.10 21.40 0.22 0.10 2.78 >0.05

2. AT 30 days 1.40 0.45 67.85 0.15 0.09 10.50 <0.001

3. AT 45 days 1.40 0.25 82.14 0.34 0.13 8.53 <0.001

4. AFU-90 days 1.40 0.65 53.57 0.30 0.12 5.94 <0.001


symptom Karapada Daha after 15 days of treatment. Vatsakadi Qwatha provided

highly significant (P<0.001) relief by 67.85% in the symptom Karapada Daha after 30


82.14% in the symptom Karapada Daha after 45 days of treatment. Vatsakadi


Karapada Daha after 90 days follow-up period.

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8. Effect of Vatsakadi Qwatha on Karapada Suptata

Table No: 55 Effect of Vatsakadi Qwatha on Karapada Suptata

Mean No. Data

BT AT % S.D S.E T P

1. AT 15 days 0.90 0.80 11.11 0.09 0.070 1.41 <0.05

2. AT 30 days 0.90 0.45 32.14 0.36 0.13 3.24 <0.02

3. AT 45 days 0.90 0.25 46.42 0.45 0.15 4.22 <0.001

4. AFU-90 days 0.90 0.35 39.28 0.26 0.11 4.69 <0.001


symptom Karapada Suptata after 15 days of treatment. Vatsakadi Qwatha provided

mild significant (P<0.02) relief by 32.14% in the symptom Karapada Suptata after 30


46.42% in the symptom Karapada Suptata after 45 days of treatment. Vatsakadi


Karapada Suptata after 90 days follow-up period.

9. Effect of Vatsakadi Qwatha on Dourbalya

Table No: 56 Effect of Vatsakadi Qwatha on Dourbalya

Mean No. Data

BT AT % S.D S.E T P

1. AT 15 days 1.55 1.30 16.12 0.19 0.10 2.45 <0.05

2. AT 30 days 1.55 0.20 87.09 0.23 0.11 12.02 <0.001

3. AT 45 days 1.55 0.15 90.32 0.56 0.17 8.09 <0.001

4. AFU-90 days 1.55 0.70 54.85 0.55 0.17 4.97 <0.001

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symptom Dourbalya after 15 days of treatment. Vatsakadi Qwatha provided highly

significant (P<0.001) relief by 87.09% in the symptom Dourbalya after 30 days of

treatment. Vatsakadi Qwatha provided highly significant (P<0.001) relief by 90.32%

in the symptom Dourbalya after 45 days of treatment. Vatsakadi Qwatha provided

highly significant (P<0.001) relief by 54.85% in the symptom Dourbalya after 90 days

follow-up period.

Effect of Vatsakadi Qwatha on Objective Parameters

1. Effect of Vatsakadi Qwatha on Fasting Blood Sugar:

Table No: 57 Effect of Vatsakadi Qwatha on Fasting Blood Sugar

Mean No. Data

BT AT % S.D S.E T P

1. AT 15 days 1.80 1.50 17.64 0.22 0.10 2.78 <0.05

2. AT 30 days 1.80 0.55 67.64 0.30 0.12 9.90 <0.001

3. AT 45 days 1.80 0.15 83.33 0.26 0.11 12.74 <0.001

4. AFU-90 days 1.80 0.65 63.88 0.34 0.13 8.5 <0.001

Vatsakadi Qwatha provided significant (P<0.05) change by 17.64% in Fasting

Blood Sugar Level after 15 days of treatment. Vatsakadi Qwatha provided highly

significant (P<0.001) change by 67.64% in Fasting Blood Sugar Level after 30 days

of treatment. Vatsakadi Qwatha provided highly significant (P<0.001) change by

83.33% in Fasting Blood Sugar Level after 45 days of treatment. Vatsakadi Qwatha

provided highly significant (P<0.001) change by 63.88% in Fasting Blood Sugar

Level after 90 days follow-up period.

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2. Effect of Vatsakadi Qwatha on Post Prandial Blood Sugar

Table No: 58 Effect of Vatsakadi Qwatha on Post Prandial Blood Sugar

Mean No. Data

BT AT % S.D S.E T P

1. AT 15 days 1.90 1.60 15.78 0.22 0.10 2.78 >0.02

2. AT 30 days 1.90 0.80 57.89 0.09 0.07 15.57 <0.001

3. AT 45 days 1.90 0.15 89.47 0.43 0.15 11.27 <0.001

4. AFU-90 days 1.90 0.65 65.78 0.40 0.14 8.52 <0.001

Vatsakadi Qwatha provided mild significant (P<0.05) change by 15.78% in

Post Prandial Blood Sugar Level after 15 days of treatment. Vatsakadi Qwatha

provided highly significant (P<0.001) change by 57.89% in Post Prandial Blood

Sugar Level after 30 days of treatment. Vatsakadi Qwatha provided highly significant

(P<0.001) change by 89.47% in Post Prandial Blood Sugar Level after 45 days of

treatment. Vatsakadi Qwatha provided highly significant (P<0.001) change by

65.78% in Post Prandial Blood Sugar Level after 90 days follow-up period.

3. Effect of Vatsakadi Qwatha on Fasting Urine Sugar:

Table No: 59 Effect of Vatsakadi Qwatha on Fasting Urine Sugar

Mean No. Data

BT AT % S.D S.E T P

1. AT 15 days 0.65 0.50 23.07 0.13 0.08 1.78 <0.05

2. AT 30 days 0.65 0.15 76.90 0.47 0.15 3.16 <0.01

3. AT 45 days 0.65 0.15 84.67 0.36 0.13 3.96 <0.001

4. AFU-90 days 0.65 0.40 38.46 0.30 0.12 1.98 <0.05

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Vatsakadi Qwatha provided significant (P<0.05) change by 23.07% in Fasting

Urine Sugar Level after 15 days of treatment. Vatsakadi Qwatha provided moderately

significant (P<0.01) change by 76.90% in Fasting Urine Sugar Level after 30 days of

treatment. Vatsakadi Qwatha provided highly significant (P<0.001) change by

84.67% in Fasting Urine Sugar Level after 45 days of treatment. Vatsakadi Qwatha

provided significant (P<0.001) change by 38.46% in Fasting Urine Sugar Level after

90 days follow-up period.

4. Effect of Vatsakadi Qwatha on Post Prandial Urine Sugar

Table No: 60 Effect of Vatsakadi Qwatha on Post Prandial Urine Sugar

Mean No. Data

BT AT % S.D S.E T P

1. AT 15 days 0.70 0.60 14.28 0.09 0.07 1.41 <0.05

2. AT 30 days 0.70 0.25 64.28 0.47 0.15 2.85 <0.01

3. AT 45 days 0.70 0.15 85.71 0.25 0.11 5.20 <0.001

4. AFU-90 days 0.70 0.30 57.14 0.35 0.13 2.91 <0.01

Vatsakadi Qwatha provided significant (P<0.05) change by 14.28% in Post

Prandial Urine Sugar Level after 15 days of treatment. Vatsakadi Qwatha provided

mild significant (P<0.02) change by 64.28% in Post Prandial Urine Sugar Level after

30 days of treatment. Vatsakadi Qwatha provided highly significant (P<0.001) change

by 85.71% in Post Prandial Urine Sugar Level after 45 days of treatment. Vatsakadi

Qwatha provided moderately significant (P<0.01) change by 57.14% in Post Prandial

Urine Sugar Level after 90 days follow-up period.

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4. Effect of Vatsakadi Qwatha on HBA1C

Table No: 61 Effect of Vatsakadi Qwatha on HBA1C

Mean No. Data

BT AT % S.D S.E T P

1. HBA1C 0.70 0.65 7.14 0.15 0.09 0.55 <0.05

Vatsakadi Qwatha provided significant change (P<0.05) by 7.14% in the

objective parameter HBA1C.

5. Effect of Vatsakadi Qwatha on DQOL: Vatsakadi Qwatha provided remarkable compliance with higher Quality Of

Life in Physical (100%), Sexual (90%), Treatment Satisfaction (50%) and in Health

Perception which was remarkably changed in 50% of the subjects from fair to

excellent score even after the follow up period.

Although; good compliance was observed after the duration of treatment in

Psychosocial (50%) and Life Satisfaction (40%) along with the above aspects of

QOL, it showed moderately poor compliance after the Follow Up period.

6. Overall Effect of Vatsakadi Qwatha After 45 days of Treatment.

Table no.62 Overall Effect at 90 days Follow Up period CRITERIA No. of patients Percentage

GOOD RESPONSE 10 50%

MODERATE RESPONSE 04 20%

MILD RESPONSE 04 20%

POOR RESPONSE 02 10%

The overall effect of the investigational product Vatsakadi Qwatha showed good

response in 10 subjects i.e 50%, moderate response in 04 subjects i.e 20%, mild

‐ 137-


response in 04 subjects i.e 20% and poor response in 02 subjects i.e 10% after 45 days

of treatment period.

7. Overall Effect of Vatsakadi Qwatha After 90 days Follow Up Period

Table no. 63. Overall Effect at 90 days Follow Up period

CRITERIA No. of patients Percentage

GOOD RESPONSE 02 10%

MODERATE RESPONSE 04 20%

MILD RESPONSE 08 40%

POOR RESPONSE 06 30%

The overall effect of the investigational product Vatsakadi Qwatha showed

Good Response in only 02 subject’s i.e 10%, Moderate Response in 04 subjects i.e

20%, Mild Response in 08 subjects i.e 40% and Poor Response in 06 subjects i.e 30%

after 90 days of Follow Up Period.

Chart no.21. Overall Effect of Vatsakadi Qwatha after 45 days of Treatment and

90 days Follow Up period.

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‐ 139‐

DISCUSSION

The present 21st century has gradually and drastically changed the attitude of

every individuals of the` society towards every aspects of life by guiding and

prompting them towards a weird quality of day to day physical and mental activities

and finally making them to lead an obsessive and erratic lifestyle, which in turn has

led to an health crisis of various lifestyle disorders. One among those topmost lifestyle

disorders is Madhumeha, which has becoming a major health threat in both developed

and developing countries. Although a number of studies had been conducted on

Madhumeha with many formulations, still early diagnosis of this iceberg disease has

found maximum focus in the recent days due to its high incidence as an etiology in

cardiac deaths123, 121.

It also has now become an important outcome of various clinical trials and

health care interventions as the study expectancy has been aimed at reducing the

prevalence and incidence rate of the same with early diagnosis121. At the same time;

timely intervention helps in preventing both short- term and long term complications

which especially has been the long term aim in the treatment of type-2 diabetes126.

The role of psychological factors in triggering the hyperglycemic condition has been

well established based on the HPA axis dysfunction through various stressors- the

disease identity of the present era121. The present study has been selected not only on

the basis of understanding the need of an effective formulation for effective

management of the condition Madhumeha, but also to understand the importance of

Purvarupa especially in this latter condition based on the Vikara Vighata

Bhavaabhava Prativishesha, which is the guiding tool for the early diagnosis of the

same19. So, discussion on the entire study on various observational and statistical

analytical data is summarized here after. The strategy for the discussion is as follows,


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1. Discussion on Review of Literature.

2. Discussion on Materials and Method.

3. Discussion on Demographic Data.

4. Discussion on Clinical Data.

5. Discussion on Diabetic Quality Of Life.

6. Discussion on Probable Mode of Action of Vatsakadi Qwatha.

DISCUSSION ON REVIEW OF LITERATURE

Discussion on Nirukthi: Literally, the meaning of the words Madhumeha and

Diabetes mellitus have many similarities, where both are used with the sense of

perfuse (watering). Regarding the usage of the term Madhumeha, Acharya

Chakrapani opines that just like a heap of grass, Truna Samuha and a single grass of

particular type Truna Vishesha ; both altogether, can be used with a single term

‘Grass’ similarly the term Madhumeha can be used for all types of Prameha- Sarva

Pramehe and for Madhumeha Visheshe - Vatika Prameha. Here for the present study

it is taken in terms of all types of Prameha not within the paradigm of its counterpart.

Hence, Asadhyata of Madhumeha is justified42, 110.

Discussion on Nidana: Literally and even clinically the extent of importance given

to the role of Nidana in the causation of this condition is well established from both

Ayurvedic and Modern parlance of etiopathogenesis and also the Nidana visheshata

and its role in causing particular extent of Doshic vitiation along with its

corresponding path of vitiating particular Dhatu, mirrors the extent of underlying

Pathophysiology and its clinical manifestation altogether. They highlight the

sedentary lifestyle along with indiscrete usage of food stuffs as the main reason for

the disease. When it comes to the discrete usage of food items especially for this

condition, lot of explanatory theories from Dravyaguna specialty will be supportive

for an Evidence Based Therapeutic and Disease Specific Dietary Approach42, 121.


‐ 141‐

Discussion on Purvarupa and Rupa: The Rupa and Purvarupa of Madhumeha are

considered to be similar by Acharya Gangadhara. This is quite similar to the clinical

features of Diabetes Mellitus. But while dealing with symptoms like Karapada Daha

and Karapada Suptata, which are considered as Purvarupa of Prameha in ayurveda21

while Peripheral Vasculopathies and Peripheral Neuropathies which in

concordance with the above are considered as the late complications of Diabetes

Mellitus by the Conventional Medicine121.

The explanatory theory for the above are as follows, Acharya Susrutha has

proposed his theory that all Prameha will attain the state of Madhumeha- Vataja, if

not treated at proper time81. So at the last stage of Prameha, the Purvarupa of

Madhumeha will appear itself as symptoms like Karapada Daha, Karapada

Suptata which is quite in accordance with the late complications of Diabetes Mellitus

but based on Vikara Vighata Bhava Abhava Prativishesha it do not hold good when

the Purvarupa of Sarva Prameha is taken into consideration and is highly liable for

Physicians Cognitive Discretion42. The explanations for the manifestation of the

above along with the other Purvarupa are as follows,

Karapadathala Daha is considered due to Ashayapakarsha Gati of Pita. It

may be also due to loss of Ambu tatva which has Sheeta property and required for

Preenanam, failing of which results in Daha. Another theory from Charakacharya

includes its relationship with the Vata Dosha as explained in the context of Avarana.

Involvement of Rakthavaha Srothodushti is established by this clinical feature

Karapada Daha, based on Asrayaasrayi Bhava between Raktha and Pita90.

The theory of persistent hyperglycemia as the primary mediator for

Endothelial Dysfunction as a result of increased rate of formation of ROS in and

around the tissues is well established as the underlying cause for Peripheral

Vasculopathies121 but, the extent of this pathology depends on the discretion of the


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predisposing etiological factors inducing or triggering the inflammatory process

within the tissues, which is in accordance with the importance of Vikara Vighata

Bhava Abhava Vishesha principle of Ayurvedic Pathology54.

Karapada Suptata: The Possible Explanatory Theory is; due to

Ashayapakarshaka Gati of Kapha and its relationship with the Vata dosha as

explained in the context of Avarana by Charakacharya90. The theory of accumulation

of AGEs and its effect on the temporory dysfunction of the Peripheral Sensory Nerves

and also its long term effect is suggestive of neurotoxicity from the sustained

hyperglycemic condition is well established121. Eventhough; with all the above

mentioned theories, it is in accordance with the extent and localization of the vitiated

doshas like Kapha and Pita in relationship with the Vata Dosha as explained in the

context of Avarana by Charakacharya and its discretion based on the Vikara Vighata

Bhava Abhava Vishesha decides the prognosis of this clinical feature which in turn

needs lot of explanatory theories in the near future for facing the present Evidence

Based Medicine Era54.

Pipasa Adhikata establishes the Udakavaha Srothodushti and is one among

the cardinal features of Madhumeha which is termed as Polydypsia in Diabetes

Mellitus. The Srotomula of the Udakavaha Srothas is stated as Kloma.

Sharngadhara111 refers Kloma as “thila”. This probably can be referred to Adrenal

Glands which are responsible for the fluid balance of the body. Any disturbance in

the homeostasis of these glands will results in multi systemic dysfunction and one

among which is severe Cellular Dehydration, which may be the reason for Pipasa

Adhikata in Madhumeha. The theory of a very high glucose level causing severe intra

and extra cellular dehydration is well established for the causation of excessive thirst

in Diabetes Mellitus121.


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Mutravaha Srotodushti in Madhumeha is marked by Prabhutamutrata. The

established pathophysiological theory behind this clinical feature is excessive fluid

loss through urination along with glucose causing severe extracellular and to some

extent in the intracellular dehydration resulting in both Polyuria and also Polydypsia

in Diabetes Mellitus120. Prabhutamutrata is due to decreased renal threshold by the

Kidneys brought about by higher glucose concentration of the blood. This leads to

increased Glomerular Filtration Rate (GFR) by the kidneys, which is stated as

Polyuria in Diabetes Mellitus. Another established theory on increased urination is

due to the consequence of osmotic diuresis secondary to the sustained hyperglycemia

during which along with the loss of glucose free water and various electrolytes are

also lost125.

It is “Bahvabadha Medas” and “Bahudrava Sleshma” 112 which are stated to

be important dushya and dosha of Madhumeha. The Srotomula for Medas is given as

Vapavahana113 which may be pointing towards pancreas? but another relative

explanation is towards the Peritoneum / Omentum for Acharya Chakrapani

explanation towards Vapavahana as “Udarasthasnigdhavartika”. The pancreatic

pathology leads to impaired glucose conversion in to triglycerides which is resulting

in the so called Bahvabadha Meda that is in concordance with the harmful LDL

cholesterol.

As far as the Ojus in Madhumeha is concerned it is always the Apara ojus

which is Ardhanjali Pramana which gets disturbed along with the elan vital and the

same circulates all over the body according to the explanatory theory of Acharya

Chakrapani in Arhte Dashamahamuliya Adhyaya48. This disturbance can be inferred

to be initiated right from the time of Nidana Sevena beyond the threshold and then

takes its initiative in bringing about the Dhatusamya Kriya during which it has to

move along with the dosha, and come across Dhatus concerned in bringing about the


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Purvarupa depending upon Vighata Bhava Abhava Vishesha which in later stage

decides the acquisition of Rupa phase of pathology. From the modern parlance, the

role of T-cell mediated tissue damage in type-2 diabetes mellitus is well established

and it is the T-cell mediated immunity which takes the pivotal role during the

progression of the disease pathology through various stages of inflammation and its

corresponding tissue injury which leads to osmotic changes within the tissues when

glucose concentration in the blood increases. Here possible explanation can be; along

with the body fluid tissue, it is the inflammatory mediators especially Cytokines, the

β-cell agonist which starts circulating all over the body through various systemic

barriers- predominantly Cardiac and Renal125; which hypothetically can be considered

as Kleda, Lasika, Dhatugata mala and vitiated dosha circulating in the blood and

getting excreted out by imparting the Samalatva to the urine along with the Ojus

finally responsible for Avilata of Mutra.

Excessive Kshudha Adhikata is another important symptom which signifies

the Medovaha Srotodushti and thus the pathogenesis established for Sthoulya by

Charakacharya should be considered. This in turn establishes the Avaranata of Kapha

dosha and Medas in relation to the Samana Vata. From the modern parlance, Failure

to use glucose for energy leads to increased utilization and decreased storage of

proteins as well as fat. Therefore, a person with severe untreated Diabetes Mellitus

suffers rapid weight loss and asthenia (lack of energy) despite eating large amounts of

food Polyphagia. Without treatment, these metabolic abnormalities can cause severe

wasting of the body tissues and death within a few weeks125.

Another important characteristic feature of the disease is Swedapravruthi.

The Abadhamedas along with the vitiated Kapha Dosha, its Vishyandatva, Gurutat,

Bahutvat and Vyayama Asahatvat is responsible for excessive Swedapravruthi.


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Dourbalya is another signicant clinical feature of Madhumeha which has

gained more focus especially from all streams of medicine in recent days and the

explanation is Asamatvat Dhatunam according to Charakacharya and established

theory from the modern parlance is; due to the increased insulin resistance in type-2

Diabetes Mellitus, the tissues fail to even utilize the available glucose and the

peripheral tissues especially muscle tissue etc suffer then, as a result, it draws energy

from the available fat tissue and also the proteins and finally causes asthenia or lack

of energy or Dourbalya125.

Atinidra and Atithandra- these are the significant clinical features which are

suggestive of vitiated state of Dhatu which decides the Pranashrita ojo dushti. ANS

dysfunction is a well established theory in uncontrolled hyperglycemic condition.

Another theory established clinically is the subjects's level of consciousness varies

depending upon the degree of Hyperosmolality125.

Discussions on Samprapti: The most important concept in the vicious cycle of

pathology of Madhumeha is the significance of the Prakruta Kapha as Ojas which gets

disturbed and altered from Badhata to Abadhata48, 90.

The Dushyas included are Meda, Mamsa, Sharira Kleda, Shukra, Shonita,

Vasa, Majja, Lasika, Rasa and Oja. The special characteristic features of these

Dushyas are in Bahvabadha form which is highly liable for physician’s cognitive

discretion90. From the modern parlance the following pathophysiological theories in

relationship with the type -2 Diabetes Mellitus are well established121, 125.

1. Impaired Lipoprotein Metabolism.

2. Endothelial Dysfunction.

3. Pro thrombotic state.

4. Atherogenic factor.

5. Inflammation.


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These pathological theories are invariably supportive for the condition termed as

Metabolic Syndrome or Syndrome X which is now considered as the changing trend

of Diabetes Mellitus into a cardiovascular disorder125.

The above explanatory theories highlights the importance Rasa Dhatu and Rakta

Dhatu and the srotas concerned which are the core substratum for the progression of

the disease pathology and its complications in its later stages.

Discussion on Upadrava: The esteemed emeritus foresight of the Ayurvedic seers

over the Upadrava of this condition Madhumeha enlisted approximately thousand

years ago36, identified and named as Diabetic Carbuncles are now well justified with

various explanatory theories based on the Altered Platelet Function along with the

Coagulating and Fibrinolytic factors, Endothelial Dysfunction and increased

Oxidative Stress121, 125. Recent DCCT studies reveal that these altered functions with

varied degree can manifest both in the early as well as in the advanced stage of this

condition but commonly noticed diabetic complications are CAD, diabetic

nephropathy and diabetic retinopathy. The above mentioned DCCT study also

highlights the importance of importance of Vikara Vighata Bhava Abhava

Prativishesha even at the stage and site of causation and clinical manifestation of

these complications termed as Pidakas which later leads to a clinical condition termed

as Putipuyamamsa - Diabetic Gangrene. Pipasa, Arochaka, Avipaka, Atisara and

Vrushanayoravadaranam are few systemic complications mentioned in Ayurveda36.

Discussion on Sadhyasadhyatha: Diabetes is not a curable disease; the treatment

Strategy is to enable subjects to lead lives Similar to those of healthy persons, while

preventing complications through appropriate Treatment and Personal Management.

To achieve this objective, it is important to reduce Psychological, Physical, and

Lifestyle Burdens and Restrictions due to diabetes as much as possible. So,

evaluation of Health-Related Quality Of Life (HRQL) is of more important for


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evaluating the burden on subjects and in selecting treatment methods. Health Related

Quality of Life measurement provides a comprehensive evaluation of the subjects’s

health status which would provide additional information to laboratory data and also

with the subjective symptoms which in turn highlights the importance and global

implementation of Dinacharya, Rtucharya and discrete utilization of classical

formulations with drug specifications and supportive evidence based explanatory

theories for the same thus meeting the required standards of care globally. Based on

Vikara Vighata Bhava Abhava Prativishesha48, 54, it is still under the sacred healing art

of Avastha Vishesha Chikitsa Jnana of Vedic Medicine which can provide effective

standards of Diabetic Care and Prognosis which in turn is highly liable for Physician’s

Cognitive Discretion90.

Discussion on Arishtalakshana: Severe persistent hyperglycemic condition leads to

cell destruction with restricted elimination of the toxins causing fruity odour125; which

attracts flies even after the bath of the subjects which in turn is a sure prognostic sign

of death mentioned for Prameha68, 69. The fruity breath odor of acetone further

suggests the diagnosis of Diabetic Ketoacidosis125. This extensive hyperglycemic

condition may produce diabetic coma and lead to death125.

1. Discussion on Materials and Methods

Discussion on Selection of Polyherbal formulation: The selection of Polyherbal

formulation was based on the following considerations,

a) The formulation should contain more potent ingredients.

b) The ingredients should have more disease specific action on Madhumeha and

dosha specific action with Mehagna property.

c) The ingredients of the formulation should be cost effective and it should be

easily available with minimum controversies.


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The formulation Vatsakadi Qwatha mentioned in Sharangadhara Samhita fulfilled

the above considerations and hence selected for present clinical study.

Discussion on Posology: The dose of the Polyherbal formulation is fixed as 50ml in

divided dose twice daily 15 min before food with equal quantity of Luke Warm Water

keeping in view that dose specification of Qwatha Kalpana is fixed to be as 2 Pala

per day by Acharya Sharangadhara110.

Discussion on Inclusive Criteria:

1. The subjects with Prabhutamutrata, Avilamutrata, along with other classical

symptoms and signs with Pipasa Adhikata, Kshudha Adhikata, Karapada Daha,

Karapada Suptata, Swedapravruthi and Dourbalya is included since these are the

cardinal features of the disease48.

2. Age group between 25-60yrs of either sex is included for the study. MODY affects

individuals <25 yrs and recent DCCT study reveals the occurrence of diabetes is now

considered more in middle aged persons due to growing erratic change in lifestyles.

This is the reason for fixing the age range as described above123.

3. The Fasting Blood Glucose Level ranging from 126mg/dL-180dL, Post Prandial

Blood Sugar level ranging from 160mg/dl-250mg/dl is selected considering the

limitations of the present study. This is based on the W.H.O approved diagnostic

criteria for Diabetes Mellitus123.

Discussion on Exclusion Criteria:

1. Age groups above 60 yrs and below 25yrs are avoided. In subjects above 60 years

the response of the medicine will be considerably below the expected due to

increased percentage of catabolic activity along with the possible disease

chronicity125. Subjects below 25 yrs avoided on the basis of the recent DCCT study

revealing MODY onset is <25 yrs. PPBS level more than 250mg/dl is avoided

considering the chronicity of the disease and limitations of the present study123.


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2. Subjects suffering with systemic ailments like Renal Disorder, Cardiac disorder etc.

is excluded since they need critical care and continuous monitoring. Sahaja and

Jathaja Madhumeha w.s.r to MODY and other genetically predisposed diabetic

conditions are excluded considering the limitations of the present study123.

3. Subjects with diabetic gangrene, carbuncles and other diabetic complications are

excluded considering the limitation of available clinical data and supportive

explanatory theories on the Polyherbal formulation for its condition specific

implementation.

Discussion on Diagnostic Criteria: The diagnosis depends on the classical

symptoms like Prabhutamutrata, Avilamutrata, Pipasa Adhikata, Kshudha Adhikata

along with other classical symptoms etc. and laboratory work up on Fasting Blood

Sugar level ≥126 mg/dl and Post Prandial Blood Sugar level ≥200 mg/dl based on

the W.H.O proposed diagnostic criteria for Diabetes Mellitus 2009123, 125.

WHO approved diagnostic criteria strictly recommends that

Glycated/Glycosalated hemoglobin, HBA1C should not be used for diagnostic

purpose. Here in the present study HBA1C was carried out before the treatment and

after 90 follow up period for assessing the pre and post – therapeutic effect of the

Polyherbal formulation -Vatsakadi Qwatha over the long term glycemic control of the

subjects. HBA1C as an objective parameter has gained maximum focus due to

peaking incidence of undiagnosed and untreated diabetic subjects; but should be

reconsidered based on its availability and cost, for the future studies125.

Discussion on Assessment criteria: Assessment on symptoms of Prabhutamutrata

(increased amount and frequency of micturition), Avilamutrata, Pipasa Adhikata,

Kshudha Adhikata, Swedapravruthi, Karapada Daha, Karapada Suptata, Dourbalya

and laboratory investigations like Fasting Blood Sugar, Post Prandial Blood Sugar,

fasting urine sugar and Post Prandial urine sugar has been done according to the self


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assessment criteria based on their normal values with grading ranges from 0-3.This

has been done for statistical analytical purpose.

Discussion on drop outs: In the present study, 30 subjects were screened and

diagnosed for Madhumeha in the conducted medical camp, out of which 5 subjects

were excluded from the study based on exclusion criteria. Among the remaining 25

subjects, 20 subjects satisfying the inclusion criteria was been taken for statistical

analysis, 5 subjects among whom 3 subjects had discontinued the treatment due to

transportation inconvenience and 2 subjects failed to attend the subsequent first

follow up without any reason and were considered as drop outs of the study. The

issue on Palatability of the Polyherbal formulation was absolutely nil among 20

subjects who were included for the present study.

3. Discussion on observations related to demographic data

1. Age: Among the 20 subjects; majority of the subjects were distributed primarily

between the age ranges of 41 - 45yrs and secondarily between the age range of 36 –

40, 51 - 55 and 56 – 60 years which clearly highlights the WHO data of age

occurrence of type -2 Diabetes Mellitus. The possible explanatory theory is due to in

discreet day-to-day physical and mental activity sufficient enough not to burn away

the hypercaloric diet along with the accelerated rate of catabolic activity due to the

disease identity of the present era – Stress which significantly affects the process of

ageing121.

2. Sex: Majority of the subjects were Females (75%) in the present study.

Hypothetically; due to their inevitable, indiscrete and unorganized day-to-day

physical and mental activities along with erratic dietary habits including untimely and

junk food stuffs121 which is evident within the age criteria.

3. Religion: Majority were Hindus. It is due to the Hindu dominated study site.


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4. Educational qualifications: Majority of the subjects was graduated which is

highly supportive for the awareness required for their progressive health plans and its

positive outcome for leading a better quality and standards of diabetic life.

5. Marital status: About 85% of subjects were married. Post marital life without

organization in their day-to-day physical and mental activities along with erratic

dietary lifestyle is quite suggestive of the disease entity of present era – Stress121, 125.

6. Occupation: Majority of the subjects were Homemakers (55%) which highlights

the indiscrete day-to-day physical and mental activities with erratic dietary lifestyle.

7. Habitat: Majority belongs to rural habitat, which supports the DCCT results with

lack of required amount of discrete physical and mental activity for optimum

utilization of the available quality of food stuffs.

8. Socioeconomic status: About 70% of the subjects belonged to Middle Income

Group, which is quite favorable with the disease identity of present era.

9. Desapradhanatha: 80% of subjects belonged to Anupa Desa, which is further

favorable for the vitiation of Kapha Dosha especially in those with sedentary

lifestyle48.

4. Discussion on data related to Subjects Clinical Findings

1) Discussion on main presenting complaints of the subjects: Although; majority

of the subjects presented with Dourbalya (100%) along with Karapada Daha (95%) as

the common presenting complaint, it was Pruritis Vulvae which presented in almost

10 female subjects along with Dourbalya and Karapada Daha which is quite

suggestive of typical clinical presentation found in type-2 female diabetic subjects125.

2) Discussions on personal history of the subjects:

a) Discussion on data related to dietary regimen: Untimely Vegetarian Diet (55%)

dominated Untimely Mixed Diet (45%) which is quite supportive for the progression

of the underlying pathology. Hence as a part of drug specification; and also as a


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dietary and lifestyle modification, subjects were reinforced for taking timely, fibrous

rich, vegetarian diet with complete abstinence from untimely, non vegetarian, and

spicy food stuffs121,122.

b) Discussion on data related to supplementary diet: Subjects who had coffee and

tea as major supplementary diet were more affected (50% and 40% respectively). The

established theory is that caffeine present in the coffee and tea are potent enough to

trigger and accelerate the rate of inflammation and thus the tissue injury caused due to

persistent hyperglycemic condition which is also supportive for reduced insulin

sensitivity and increased insulin resistance. As a part of drug and disease specification

it was strictly advised for a regulated dose of these beverages while chats, soft drinks

were completely restrained from the subject’s dietary regimen.

c) Discussion on data related to Vyasana: Five of the female subjects were reported

to have habit of pan chewing and 02 male subjects were reported to have the habit of

cigarette smoking which is known for amplifying inflammation via AGEs121, 122.

d) Discussion on data related to Agni and Koshta: Vishamagni and Mandagni were

observed in maximum number of subjects which clearly indicates the status of Krura

and Madhyama Koshta in relation with the dosha and its extent of vitiation in causing

the clinical manifestation of Purvarupa in Madhumeha subjects based on Vikara

Vighata Bhava Abhava Prativishesha48.

e) Discussion on data related to Stress: 50% of the subjects revealed disturbed sleep

which contributes for the HPA axis dysfunction. At the same time 85 % of the

subjects were observed to have Madhyama satva and 15% with Avara satva which is

quite supportive for susceptibility to Peak Stress Crisis and the subsequent episodes of

persistent hyperglycemic condition leading to Immune suppression121, 122.


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3) Discussion on data related to Systemic effect:

a) BODY MASS INDEX: Majority of the subjects came under the paradigm of

normal range while two were under over weight and another was within the obese

range. This in turn highlights the presence of possible Mild Hypertensive condition

and also Atherosclerotic Vascular Changes as established in updated version of

CMDT 2009125.

b) EVIDENCE OF INSULIN RESISTANCE: The signs of dehydration like dry

flaky skin and Acanthosis Nigricans are quite suggestive of Udakavaha and

Mamsavaha Srotodushti which in turn can be considered as the evidence of

underlying insulin resistance and was observed only in few subjects.

4) Discussion on data related to Prakruthi: In the present study; Vatakapha Prakruti

(35%) showed maximum tendency of getting Madhumeha and subsequently by

Kaphapitha and Vatapita Prakruti for about 25% each. The disturbed state of Ambu

Tatva of Kapha, Agneya tatva of Pita and Yogavahi Tatva of Vata altogether or in

combination with one another plays a vital amplifying role in the successive

progression of vicious cycle of pathology at various levels with varied degree within

the Dhatu in Madhumeha.

5) Discussion on data related to Vikruthi: The observation on Vikruthi showed

significant involvement of Rasa (100%), Medas (100%), Rakta (85%), Mamsa (90%),

and Shukra (45%) Dhatu’s respectively. This clearly signifies the affliction of

respective Avaraka Dosha- Kapha and Pita predominantly and Vata in corresponding

Dhatu in varied degree. Based on Ashrayaashrayi Bhava and Vikara Vighata Bhava

Abhava Prativishesha; the Vikruthi in all the subjects’ falls within the paradigm of

Madhyama and Avara.

6) Discussion on data related to Nidana: The observation on Nidana revealed

important factors like untimely food habits – Carbohydrate, Fat rich diet, excessive


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junk foods, spicy non vegetarian diet (100%), indiscrete aimless physical activities

(100%) along with enough worthless worries, anger, grief and frustrations and

emotional breakdowns (100%) responsible enough to initiate and amplify the vicious

cycle of pathology of the disease Madhumeha, both from the ayurveda and modern

parlance.

7) Discussion on data related to Dhatu involved symptoms: Alasya;

Procrastination, a Rasa Dhatu involved symptom is observed in 100% of the subjects

is suggestive of impaired Dhatvagni –process of tissue metabolism in Madhumeha.

Swedapravruthi and Dourbalya are suggestive of Medo Dhatu involvement in

Madhumeha. Karapada Daha and Karapada Suptata are suggestive of Rakta Dhatu

and its Upadhatu involvement.

5. DISCUSSION ON DIABETIC QUALITY OF LIFE

Although; Quality of life is a subjective and complicated experience which is

widely used as an indicator in different recent clinical trials and descriptive studies on

either types of Diabetes Mellitus, here only Selective and relevant Questions from the

WHO approved and DCCT validated Questions in relation with the clinical findings

related to type-2 were adopted for assessing and scoring of Diabetic Quality Of Life.

Various recent DCCT studies on DQOL have revealed that there seems to have a

negligible relationship between QOL and age or duration of diabetes but it is the

physical signs and symptoms which have shown a remarkable relationship with the

QOL of the diabetic subjects.

As per the recent objectives proposed by WHO on diabetics patient care; all

the subjects were sufficiently co-operative for assessing the diabetic quality of life

which revealed a remarkable compliance with higher QOL in Physical (100%),

Sexual (90%), Treatment Satisfaction (50%) and in Health Perception which was


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changed in 50% of the subjects from fair to excellent score even after the follow up

period. The possible explanation for these findings is that firstly; majority of subjects

were new patients having diagnosed DM < 3 years with no complications and on no

Oral Hypoglycemic Agents Secondly, significant relief in the subjective parameters

especially of Dourbalya (P<0.001) even after follow up period. Although; good

compliance was observed after the duration of treatment in Psychosocial (50%) and

Life Satisfaction (40%) along with the above aspects of QOL, it showed fair

compliance after the follow up period.

6. PROBABLE MODE OF ACTION OF VATSAKADI QWATHA

Considering the findings based on the Vikara Vighata Bhava Abhava

Prativishesha; the probable mode of action of the Polyherbal formulation–Vatsakadi

Qwatha can be analyzed based on the involvement of respective Dosha, Dushya,

Sanga and Atipravruti type of Srotodushti and Agni, as the main pillars of discussion.

The possible explanatory theories supporting the probable mode of action of

the Polyherbal formulation- Vatsakadi Qwatha used for the present study are

discussed hereafter based on the following headings,

1. Probable mode of action on assessment Criteria’s.

2. Based on the theory of Rasa Panchaka.

3. Based on Recent Drug Research.

4. Based on Phytochemical analysis.

1. PROBABLE MODE OF ACTION OF VATSAKADI QWATHA ON

SUBJECTIVE PARAMETERS

a. Mode of action on Prabhutamutrata: The possible explanatory theory; Kapha

Pita Kleda Upashoshana Kriya of Vatsaka and Mala Shodhana effect of Triphala,

Daruharidra, Musta and Bijaka might possibly have helped in regulating the


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amount and frequency of micturition which on the other side might support the theory

of inhibiting inflammation induced excessive cellular dehydration caused due to

persistent hyperglycemic condition120, 121, 122.

b. Mode of action on Avilamutrata: The possible explanatory theory; Amapachana,

Vatanulomana Kriya, Mala Shodhana, and Kaphapita Nashaka Kriya of Triphala,

Dosha Pachana Kriya of Daruharidra, Rasayana Kriya of all the drugs might

possibly have helped in rectifying the Samalatva of Mutra to Nirmalatva which on the

other side might support the theory of glycemic control through restricting the

formation of AGEs and its timely evacuation from the body121, 122.

c. Mode of action on Pipasa Adhikata: The possible explanatory theory; Trushna

Nigrahana Kriya of Musta and the Qwatha Kalpana might have possibly helped in

regulating the above symptom which on the other side supports the theory of

regulating the fluid and electrolytic balance by inhibiting inflammation induced

excessive cellular dehydration and subsequent fluid and electrolyte loss caused due to

persistent hyperglycemic condition120, 121, 122.

d. Mode of action on Kshudha Adhikata: The possible explanatory theory;

Amapachana, Kaphapita dosha Shamana, Medohara Kriya of Musta, Bijaka,

Daruharidra along with Vatanulomana Kriya of Triphala might possibly have

helped in removing the Avarana between Vata Dosha and Medo Dhatu thereby

rectifying Kshudha Adhikata, which on the other side might support the theory of

regulating the Hepatic and Intestinal Metabolic Activity122.

e. Mode of action on Karapada Daha: The possible explanatory theory is Kleda

Upashoshana Kriya of Vatsaka, Amapachana, Kaphapita dosha Shamana,

Vatanulomana Kriya of Triphala along with Rasayana Kriya might have helped in

bringing back the Dosha - Pitakapha to their normal site and perform normal

physiological function thereby rectifying Karapada Daha which on the other side


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might support the theory of reducing the persistent hyperglycemic condition induced

Tissue Injury and the subsequent Endothelial Dysfunction121,122.

f. Mode of action on Karapada Suptata: The possible explanatory theory is Kleda

Upashoshana Kriya of Vatsaka, Amapachana, Kaphapita dosha Shamana,

Vatanulomana Kriya of Triphala along with Rasayana Kriya might have helped in

bringing back the Dosha – Kaphapita to their normal site and perform normal

physiological function thereby rectifying Karapada suptata which on the other side

might support the theory of reducing the persistent hyperglycemic condition induced

ROS formation and its subsequent Neurotoxicity121.

g. Mode of action on Dourbalya: The possible explanatory theory ; Agni Deepana,

Amapachana, Srotoshodhana, Malashodhana, Srotoshudhi, Malashudhi and Rasayana

Kriya of all the drugs in the Polyherbal formulation might possibly have helped in

rectifying Dourbalya which on the other side might support the theory of multi

systemic and synergistic anti-inflammatory and anti hyperglycemic action of all the

drugs in the Polyherbal formulation promoting enhanced insulin sensitivity and

reduced insulin resistance, most importantly enhancing the hepatic uptake of glucose

and subsequent process of Glyconeogenesis followed by proper utilization of glucose

by the peripheral tissue121,122.

h. Mode of action on Swedapravruthi: The possible explanatory theories are Agni

Deepana, Amapachana, Kleda Upashoshana along with Srotoshodhana, Medohara

and Rasayana Kriya of all the drugs in the Polyherbal formulation might possibly

have helped in reducing the Adhika Sweda Pravruthi which on the other side might

possibly support the theory of reduced Lipid Peroxidation especially within the

liver122.


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OBJECTIVE PARAMETERS:

a. EFFECT ON FASTING BLOOD SUGAR LEVEL: It signifies the enhanced process

of hepatic gluconeogenesis which is hampered due to persistent hyperglycemic level.

b. EFFECT ON POST PRANDIAL BLOOD SUGAR LEVEL: It signifies the process

of glucose uptake by the peripheral tissues especially skeletal muscles induced by

reduced insulin resistance.

c. EFFECT ON FASTING URINE SUGAR: It signifies the reduction in the renal

threshold..

d. EFFECT ON POST PRANDIAL URINE SUGAR: It also signifies the glycemic

control especially enhanced insulin sensitivity and reduced insulin resistance in the

peripheral tissues.

e. EFFECT ON HBA1C: Although not much change was observed after the follow up

period it still signifies the accummulation of AGEs along with a long term glucose

control.

2. BASED ON THEORY OF RASA PANCHAKA

a) Probable mode of action based on the Rasa: If we analyze the percentage of

Rasa –Inspite of the presence of Lavanavarjita Pacharasa Yukta Oshadhi Dravya like

Amalaki and Haritaki the formulation is dominated by Kashaya. Tikta and Katu

Rasa’s because of the presence of Vatsaka, Daruharidra, Musta and Bijaka. From the

above criteria, it is evident that Kaphapita Nashaka Kriya and Vata Shamana Kriya

are possible from this Polyherbal formulation. So; Vatsakadi Qwatha is potent enough

to bring back Prakupita Kaphapita Dosha, which is responsible for Margavarana of

the vata dosha to its balanced state and thus breaking the vicious cycle of

pathogenesis of the disease Madhumeha. At the same time, it nullifies the effect of

the toxic exposure of the Dhatu’s to the same and promotes restoration.


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b) Probable mode of action based on Guna: It is nothing short of a miracle that all

the drugs in the Polyherbal formulation- Vatsakadi Qwatha are possessing Laghu and

Ruksha Guna in common but liable for discretion regarding its extent. However; the

criteria is quite supportive for the required Ulekhana action for Srotoshudhi, which in

turn provides Medohara, Kaphahara and Lina dosha Nashaka effect altogether.

c) Probable mode of action based on Virya: The drugs in the Polyherbal

formulation- Vatsakadi Qwatha possess Ushna and Sheeta Virya in the ratio 4:3,

which is quite supportive for not only for the reduction of Kleda an Lasika but also for

maintaining the normal homeostatic nature of vata dosha by amplifying Tridoshahara

and Medohara effect and thus break up the vicious cycle of pathology of the disease

Madhumeha. At the same time, it promotes the formation of Prashasta Dosha, Dhatu

and thus restores Dhatu Samyatva.

d) Probable mode of action based on Vipaka: The drugs in the Polyherbal

formulation- Vatsakadi Qwatha possess Madhura and Katu Vipaka in the ratio 3:3,

which is quite supportive for promoting and restoring the normal functions of the

damaged Dhatu by nullifying and rejuvenating the Dhatu from the effect of Prakupita

Dosha and thus restore Dhatu Samyatva.

e) Probable mode of action based on Karma: The drugs in the Polyherbal

formulation- Vatsakadi Qwatha possess Kaphapitahara and Tridoshahara activity in

the ratio 5:2 and also with Kledopashoshana, Sangrahi, Jvaragna, Medohara, Mutrala,

Chakshushya, Trushnanigrahana, Kandugna, Kushtagna, Stanya Shodaka,

Virechnopaga, Rasayana and Vajeekarana activities altogether responsible for

restoration of Dhatu Samyatva.


‐ 160‐

3. BASED ON RECENT DRUG RESEARCH124

As already mentioned in the introductory section of this study; there are few drugs in

the Polyherbal formulation- Vatsakadi Qwatha, which are proven to have

hypoglycemic effect and are also on the verge of proving various other biological

effect over the human body. They are,

1. Vatsaka: Anti-Oxidant, Anti-Bacterial, Anti-Inflammatory, Anti-Viral and Anti

Diarrheal – these actions might possibly have helped in overcoming the process of

pathological cycle within the intestines by reducing the inflammatory tissue response

and regulating the absorptive nature of the intestinal bacterial flora by strengthening

and toning up the intestinal walls by timely evacuation of AGEs from the system122,

which correlates with the theory of Charakacharya - Kapharaktapitasangrahana Tatha

Upashoshananam Kutaja Tvak – liable for physician’s cognitive discretion104. This

also supports for the pacification of Pruritis vulvae and generalized body itching –

Hepatoprotective action on the verge to be established122, 124.

2. Triphala: Anti-Oxidant, Anti-Pyretic, Anti-Lipidemic, Anti Inflammatory,

Hepatoprotective, Cardioprotective and Anti-Diabetic activity of Haritaki, Amalaki

and Vibhitaki with carbohydrate rich content are potent enough to reduce the vicious

cycle of pathology by timely evacuation of AGEs from the blood stream and β-cell

stimulation. In coordination with the other drugs it reduces the insulin resistance and

increases the insulin sensitivity of the peripheral tissues by stimulating Adiponectin, a

potent Insulin Sensitizer122, 124. The above description can be justified with the

following reference ||Triphala Kapha Pitagni Mehakushtahara Apara | Chakshushya

Dipani Vrushya Vishama Jvara Nashini ||104

3. Daruharidra - Anti-Oxidant, Anti-Pyretic, Anti-Lipidemic, Anti Inflammatory,

Hepatic Stimulant, Hepatoprotective, Anti-Ulcerogenic, Anti-Adhesive Anti-

Bacterial, Anti-Platelet Aggregation and Anti-Diabetic activity; mimics Anti-Septic


‐ 161‐

and Anti Pruritic on the verge for its establishment altogether promotes glycemic

control right from correcting the Cardiohepatic – due to Anti-Arrhythmic effect and

protects hepatocellular damage due to persistent hyperglycemic state, Cardiorenal

systemic dysfunction synergistically122, 124..

4. Musta- Anti-Pyretic, Anti-Lipidemic, Anti Inflammatory, Hepatic Stimulant,

Hepatoprotective, diuretic activities which are already established – are supportive

enough to bring about the glycemic control by correcting the cellular dehydration and

osmotic diuresis121,122, 124.

5. Bijaka- Anti-Hyperglycemic, Anti- Hyperlipidemic, Cardiotonic,

Hepatoprotective, Anti Oxidant, Anti Inflammatory, insulin- like activities are quite

supportive for glycemic control and reduction in common symptoms of Diabetes

Mellitus through correcting the pathway of insulin by protecting and restoring the β-

cell function, reducing the inflammatory tissue response by inhibiting the

prostaglandin and COX-2 inhibiting activity, also protecting the hepatocellular

damage122, 124.

Also recent study entitled “Effect of Triphala in pancreatitis for β cell

restoration” is really encouraging for the life science professionals for having an

upper hand for the better standards of diabetic care in the near future.


‐ 162‐

4. BASED ON PHYTOCHEMICAL ANALYSIS

The Phytochemical and qualitative study result and its relevance are as follows,

1. The Acidic pH value in this Polyherbal formulation Vatsakadi Qwatha

– amplifies the rate of absorption of the drug within the Stomach, Upper gastro

intestinal tract thus rendering better bioavailability in the intestines.

2. The Specific Gravity of Vatakadi Qwatha- 1037 – which might possibly

have supported in better absorption of the drug.

Carbohydrates –present in this Polyherbal formulation Vatsakadi Qwatha.Plant

energy storage components are referred to as carbohydrates. Plant starch, gums,

mucilage, cellulose are all Polysaccharides. These along with their derivatives are

known to exert a beneficial action on the body's immune system, increasing in

strength, whose derivatives have been developed as bulking agents for the alleviation

of constipation and as agents meant to reduce the appetite

(Ref - Tyler et.al.44-45).

Bitter Tannins - These bitter tannins along with the Anthroquinone glycosides in

Vatsaka, Triphala etc. are known for their Anti-hyperglycemic, Anti-inflammatory,

Anti-diarrheal, Anti-viral, Antiparasitic, Anti-allergic, Anti-thrombotic and

Vasoprotective properties. These plant constituents exert antioxidant effects on free

radicals in the body – (Ref - Plant Material Medica and Harborne and Baxter, 84).

Alkaloids - Alkaloids like Conessine in Vatsaka for Anti Inflammatory, Anti Oxidant

and Vaso protective action – Chemistry of Natural Compounds. Vol.35, 1999,

Berberine in Daruharidra, Epicatechin in Bijaka etc is known for their Anti-

hyperglycemic, anti-lipidemic, Hepatoprotective action –(Ref- Dukes Phytochemical

And Ethnobotanical Database).

Saponins – Sesquiterpenoids, Terpenoid Saponins in Musta for Anti Inflammatory,

Anti Pyretic, Hepatoprotective and Anti lipidemic action and also for have been used


‐ 163‐

to stimulate actions within the body such as mucosal or gastric secretion, as an

antibiotic, antiviral, and bitter tonic – DeFeudis, 1991; Harborne and Baxter,

PD2447; Petkov et al., 106).

Steroidal Saponins – Pterostilbene in Bijaka is proven to be Cardiotonic and

Hepatoprotective - Harborne and Baxter, 689.

Phytosterols – These are necessary plant membranes and plant cell growths. B-

Sitosterol decreases the risk of atherosclerosis by lowering plasma concentrations of

LDL's (low-density lipoproteins) - Lehninger, 614.

Phenolic and Flavanoid compounds - These are known to be beneficial as powerful

Antioxidants, Stress Modifiers, Anti-Allergic agents, Anti-Viral compounds and Anti-

Carcinogens - Evans, 420. Some are able to stimulate protein synthesis, and some are

known Anti Inflammatory agents. Still others have demonstrated Vaso-protective

activity. Some are Diuretic, Antispasmodic, Antibacterial, and Antifungal - Harborne

and Baxter, 367-415.

All the above Chemical Compounds and proposed pharmacokinetic activity present in

Vatsakadi Qwatha supports and fulfills the recent pharmacological invention related

to a herbal composition for the treatment of Diabetic Mellitus and Metabolic

Syndrome where in one of its embodiment; the invention provides a composition

comprising of anti hypoglycemic agent, anti inflammatory agent, anti hyperlipidemic

agent, anti oxidant agent and a gastro intestinal agent with at least one of these agents

being derived from a plant while, Vatsakadi Qwatha completely satisfies with all

from the plant source itself.

All the above theories related to the drug review fulfills the purpose of

bringing about synergistic action by the Polyherbal Formulation-Vatsakadi Qwatha

and thus potent enough to break the vicious cycle of pathogenesis – Samprapti


‐ 164‐

Vighatana in Global Systemic Illness like Madhumeha vis a vis type-2 Diabetes

Mellitus.

MERITS AND DEMERITS OF THE POLYHERBAL FORMULATION

VATSAKADI QWATHA

The following are the merits and demerits of the Polyherbal formulation – Vatsakadi

Qwatha selected for the present study.

MERITS:

1. A potent Polyherbal formulation for the management of Madhumeha w.s.r to

diabetes mellitus (NIDDM).

2. All the drugs are easily available.

3. Palatability was satisfactory.

4. It has proved better effect in controlling glucose level in diabetics without any

adverse events in the present study.

DEMERITS:

1. It is costlier comparatively.

2. Portability was another demerit noticed in the present study.

3. Long term administration of the drug is still questionable due to Lack of

sufficient clinical data.

4. Long term storage of this Qwatha is a problem.


CONCLUSION

After critical analysis and systematic clinical work, the following conclusions can be

drawn on the action of formulation Vatsakadi Qwatha on Madhumeha.

1. The disease review reveals lot of similarities between Madhumeha and Diabetes

Mellitus and importance of Purvarupa of the disease extending into its Rupa phase is

well established based on the emeritus concept of Vikara Vighata Bhava Abhava

Prativishesha.

2. Observation reveals those individuals who are accustomed to indiscrete physical and

mental activities along with erratic dietary regimen especially in middle aged house

wives showed maximum susceptibility for the disease Madhumeha.

3. The clinical trial of Vatsakadi Qwatha showed significant reduction in all the clinical

features, in particularly Dourbalya, Karapada Daha and Pipasa Adhikata reduced

predominantly followed Prabhuthamutratha, Kshuda Adhikata, Swedapravruthi,

Avilamutrata after 45 days of treatment period. After 90 days follow up period

showed less significant in all the subjective parameters, except in Dourbalya.

4. The clinical trial and assessment reveals the formulation successfully reduced FBS,

PPBS, and Urine sugar levels within a short period of the treatment which signifies

role of glycemic control by the Polyherbal formulation – Vatsakadi Qwatha.

5. Observation on Glycated hemoglobin – HBA1C was not changed markedly with

respect to pre and post test design.

6. Overall effect reveals that, the formulation is highly significant during treatment

period of 45 days. So it justifies the alternate hypothesis during the treatment period.

‐ 164

7. The formulation showed insignificant result during the follow up period i.e 90 days of

observation without medication. So it substantiates the null hypothesis after the follow

up period.

‐


8. The formulation did not show any adverse events either during the treatment period or

during the follow up period. So this is suggestive that the drug Vatsakadi qwatha is an

effective as well as an ideal drug for effective management of the disease Madhumeha

w.s.r to Diabetes Mellitus (NIDDM).

SCOPE OF FURTHER STUDY:

1. As the study was conducted over a small sample, a similar study performed over a

large sample for a longer period would have procured much sharper and accurate

results.

2. Comparative studies may provide the required specification for the formulation.

3. Efficacy of the drug should be checked in type-1 and also in diabetic complications.

4. The effect of the drug along with Shodhana therapy should be critically analysed.

5. The efficacy of formulation in Ghana Vati Kalpana should be checked.

6. To appreciate any positive changes with respect to the HBA1C, it would be ideal to

administer the drug for more than 4 months.

‐ 165 ‐


SUMMARY

The present study entitled “CLINICAL EVALUATION OF VATSAKADI

QWATHA IN THE MANAGEMENT OF MADHUMEHA WITH SPECIAL

REFERENCE TO DIABETES MELLITUS (NIDDM)” comprises of different

topics discussed under the following headings.

1. Introduction: This section deals about Multi-Dimensional Ayurvedic Perception

towards the health, disease and therapeutics; brief analysis of the historical

background of the disease Madhumeha, its present status in 21stcentury with

prevalence and incidence of the disease Madhumeha among world population.

2. Objectives: This section deals with the main aims and objectives of the present

study along with the Null and Alternate Hypothesis.

3. Review of Literature: This section deal with the collection of data regarding

Etymology, Definition, Classification, Nidana, Purvarupa, Rupa, Samprapti,

Sadhyasadhyata, Upadravas, Arishta Lakshanas and Chikitsa along with Pathyapathya

of the disease Madhumeha. This section also deals with the modern conception

towards the disease Diabetes Mellitus: its Clinical information, Diagnostic Criteria

approved by WHO and its related therapeutic information.

4. Methodology: This section deals with the detailed description of clinical study

with respect to Subject Grouping, Selection, Inclusion and Exclusion Criteria,

Treatment Protocol, Duration of the Treatment, Assessment Criteria for both

Subjective and Objective Parameters along with Diabetic Quality of life

questionnaire, Overall Assessment Criteria and Study Design of the present study.

- -

166


5. Results: This section deals with the result obtained after completion of 45 days of

Treatment and 90 days of Follow Up period. The scoring of Subjective and Objective

Parameters of Madhumeha before and after treatment are statistically tabulated and

percentage of response is calculated and analyzed using student paired‘t’ test. The

total relief obtained after the treatment schedule was recorded as-

i) GOOD RESPONSE.

ii) MODERATE RESPONSE.

iii) MILD RESPONSE.

iv) POOR RESPONSE.

After 45 days of Treatment Period, the investigational product Vatsakadi

Qwatha showed good response in 10 subjects i.e 50%, Moderate response in 04

subjects i.e 20%, Mild response in 04 subjects i.e 20% and Poor response in 02

subjects i.e 10%.

After 90 days of Follow Up period, the investigational product Vatsakadi

Qwatha showed Good Response in only 02 subject’s i.e 10%, Moderate Response in

04 subjects i.e 20%, Mild Response in 08 subjects i.e 40% and Poor Response in 06

subjects i.e 30% Thus, the investigational product Vatsakadi Qwatha showed overall

significant result during treatment period than compared to Follow Up Period.

6. Discussion: This section deals with discussions pertaining to Nidana Panchaka,

Observations and Results obtained from the present study. The probable mode of

action of the investigational product Vatsakadi Qwatha based on Rasa Panchaka

theory of individual drugs in relation with the management of Madhumeha has been

discussed. This section also deals with the discussions regarding recent Pre-Clinical

- -

167


and Clinical Evidential Studies for each and every ingredients of the investigational

product Vatsakadi Qwatha along with its Phyto-Chemical Analysis.

7. Conclusion: This section deals with the conclusion of the above study by

highlighting the outcome of the study and the scope for further studies.

- -

168


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CASE REPORT FORM

POST GRADUATE DEPARTMENT OF KAYACHIKITSA

A.L.N. RAO MEMORIAL AYURVEDIC MEDICAL COLLEGE, KOPPA

P.G. Scholar: Dr.Srikrishna H.A Guide: Dr .Suresh. R.D,

MD (Ayu), MS(C&P),CYS..

Patient’s Name: SL No:

Age/ Sex: ….Yrs M/F OPD/IPD:

Religion: Ward/Bed No:

Education: D.O.A:

Marital Status: D.O.D:

Occupation: Diagnosis:

Postal Address: Result:

PATIENT CONSENT FORM

I __________________________________________ exercising my

free power of choice, hereby give you my complete consent to be

included as a subject in the present Clinical Study. I have been

informed to my satisfaction by the attending Doctor, the purpose of the

Clinical Study and the nature of drug treatment, therapeutic procedures,

follow-up and probable complications. I am also ready to undergo

necessary Laboratory Investigations to monitor and safeguard my body

functions.

I am also aware of my right to opt out of the trial at any time

during the course of the trial without having to give the reasons for

doing so.

Signature of the Doctor Signature of the Patient/ Guardian


CHIEF COMPLAINTS

1) Prabhutamutrata with Duration:

Amount of urine: Markedly increased / Increased / slightly increased/Normal

Frequency of urination:

Diurnal: Markedly increased / Increased/ Slightly increased/ Normal Nocturnal: Markedly increased/ Increased/ Slightly increased/ Normal

2) Avilamootrata (Turbid Urine) with Duration:

Appearance of Urine: Grading with Standard Sample (Testube Background

News paper method)

Clearly readable/Readable/can read with difficulty/cannot read the letters.

3) Pipasa with Duration:

Markedly increased / Increased / slightly increased/Normal

4) Kshudha with Duration:

Markedly increased / Increased/ slightly increased/ Normal

5) Sweda Pravruthi with Duration:

Markedly increased / Increased/ slightly increased/ Normal

6) Karapadathala Daha with Duration:


7) Karapadathala Suptata with Duration:


8) Dourbalyam with Duration:


HISTORY OF PRESENT ILLNESS

HISTORY OF PAST ILLNESS

FAMILY HISTORY


1. Known DM in first degree relative - Present/Absent 2. Known DM in second degree relative - Present/Absent 3. Known DM in third degree relative - Present/Absent

PERSONAL HISTORY

Habits: Micturition:

Diet: Bowel habit:

Vyayama: Appetite:

Nidra: Others:

MENSTRUAL HISTORY

GENERAL EXAMINATION

Pulse: Built:

B.P: Pallor:

Temperature: Icterus:

Heart Rate: Cyanosis:

Respiratory rate: Edema:

Lymphadenopathy: Nail changes:

Height: Weight:

Physique: Obese / Moderately Built/ Asthenic

SYSTEMIC EXAMINATION

1. Urinary System: Inspection: Skin: Dry and flaky / dirty brown appearance / Uremic frost on the forehead / Pitting oedema on ankles and sacrum/oedema at genitals/facial puffiness. Nail: Leuconychia/Splinter Hemorrhages Palpation: Left kidney: Palpable lower end (abnormal) /not palpable (normal) Right kidney: Lower end Palpable (normal) / not palpable (if removed) If abnormal: Unilaterally palpable kidney / bilaterally palpable kidney 2. Cardiovascular System:

Inspection and palpation:


Arterial pulse: Tachycardia/Bradycardia/normal

Rhythm: Normal/abnormal

Abnormal pulsations on Precordium: present/absent

Blood Pressure:

Auscultation:

Abnormal Heart Sounds: Murmurs/ Additional heart sounds

The peripheral pulses of upper limb: All present and equal/ All present and unequal/Absence of pulses noted.

The peripheral pulses of lower limb: All present and equal/ all present and unequal/Absence of pulses noted.

Bruits: Present/Absent

Abnormalities on ECG:

Central Nervous System:

Mental stage:

Gait:

Cranial Nerves:

Fundi:

Pappiloedema: Present/Absent

Optic atrophy: Normal/Abnormal

Hypertensive changes/Ureamic changes/Diabetic changes

Motor:

Sensory:

Position sense in fingers and toes (Post. Columns): Normal/ Abnormal

Pin prick test of limbs and face (Lateral Spinothalamic tract): Normal/Abnormal

Response to light touch - positive/negative.

ASTASTANA PAREEKSHA:

1. Nadi: 5. Sabda:

2. Muthram: 6. Sparsa:

3. Malam: 7. Drik:


4. Jihwa: 8. Akruti:

DASAVIDHA PAREEKSHA

Prakruthi:

Sara:

Samhanana:

Pramana:

Satva:

Satmya:

Vyayamasakthi:

Aharasakthi:

Vaya:

Vikruthi:

SROTHO PAREEKSHA

1. Udakavahasrothas: Jihva Shosha/ Talu Shosha/Oshta Shosha/Kanta Shosha/Mukha Shosha/Tamas/ Pravrudhapipasa

2. Rasavahasrotas: Shithilagatrata/ Karapadasupthatha/ Klaibya/ Shrama/Agnimandya/Gourava/Alasya/Atinidra/Asyamadhurya/Arasajnata/Aruchi

3. Rakthavahasrotas: Karapadasupthatha/ Karapadadaha/ Rakthasrava/ Pidaka/ Vidradhi/ Kotha/ Mukhapaaka

4. Muthravahasrothas: Prabhuthamutrata/ Avilamutrata/ Makshikaakranta Mutrata (Pipilika Abhisarana)/ Sashulamutrata NIDANAM

1. AHARAM Present Absent

a) Excess carbohydrate rich Diet

(Rice, Jaggery and Grains etc..)

b) Excess fat rich Diet

(Curd, Anupa mamsa, Oudaka Mamsa, Butter, Sweets, Mamsa of Domestic animals)

c) Amount of food Mild Moderate Excess

2. VIHARAM Present Absent


a) Asyasukham

(Sedentary sitting & Sex habits)

b) Swapnasukham

(Sedentary sleeping Habits)

c) Lack of exercise

3. MANASIKA NIDANA Present Absent

a) Chintha

b) Shoka

c) Udwega

PURVARUPAM

Present Absent

a) Karapadathaladaham

b) Pipasa

c) Dantamalam

d) Nayanamalam

e) Karnamalam

f) Alasyam

g) Shareera Dourgandhyam

h) Athinidra

i) Athithandra

j) Karapadathalasuptatha

k) Keseshu Jatileebhavam

l) Asyamadhuryam

DHATU INVOLVED SYMPTOMS

a) Rasa (Vruddhi): Praseka/ Alasya/ Gaurava

b) Medas (Vrudhi): Shramaswasa,/ Lambhana of Sphik/Stana

c) Majja (Ksheena): Asthisousheerya - Present/ Absent

d) Vasa (Ksheena): Mamsakshaya - Present/ Absent


e) Lasika: Mamsatwagantara Udaka Kshaya - Present/Absent

f) Ojus (Ksheena): Impaired Psychological, physical or Disease

Specific strength of the individual - Present/ Absent

UPASAYAM / ANUPASAYAM

SAMPRAPTI GHATAKA

Dosha : Dushya :

Srotas : Srotodushti :

Agni : Ama :

Udbhava sthana : Sanchara Sthana:

Adhishtana : Vyaktha sthana:

Rogamarga : Vyadhi swarupa :

INVESTIGATIONS

No

BIOCHEMICAL INVESTIGATIONS RESULTS

1 F.B.S

2 P.P.B.S

3 HbA1C

4 F.U.S

5. P.P.U.S

DIAGNOSIS: Madhumeha

Treatment Started on:

Treatment Ended on:

Follow up Started on:

Follow up Ended on:

Medicine: Vatsakadi Qwatha

Treatment Duration: 45 days

Follow up Duration: 90 days.


ASSESMENT OF RESULTS

Parameters B.T D.T AT AFU No

Subjective 0 15 30 45 60 75 90 105 120 135

1.a P.M(Amount)

B P.M (Frequency)

2 Avilamutrata

3 Pipasa

4 Kshudha

5 Sweda Pravruthi

6 Karapadathala Daha

7 Karapadathala Suptata

8 Dourbalyam

Objective 0 15 30 45 60 75 90 105 120 135

Blood Sugar

FBS

1

PPBS

HbA1C

Urine Sugar

FUS

2

PPUS

REMARKS: No response Mild response

Moderate response Marked response

Signature of P.G Scholar Signature of Guide


DQOL Questionnaire

Sl no. QUESTIONS SCORING I. PHYSICAL 1. How often do you feel physically ill? 1 2 3 4 5

2. How often do you have bad night sleeps? 1 2 3 4 5

3. To what extent do you have difficulty in performing your routine activities?

1 2 3 4 5

4. How much are you bothered by any limitations in performing everyday living activities?

1 2 3 4 5

5. How often do you feel fatigue? 1 2 3 4 5

II. PSYCHOSOCIAL 1. How satisfied are you with your social relationship? 1 2 3 4 5

2. How often do you feel good about yourself? 1 2 3 4 5

3. Do you get the kind of support from others that you need?

1 2 3 4 5

4. How much do you experience positive feelings in your life?

1 2 3 4 5

5. How well are you able to concentrate? 1 2 3 4 5

III. SEXUAL 1. How often does your diabetes interfere with your sex

life? 1 2 3 4 5

2. How satisfied are you with your sex life? 1 2 3 4 5

3. How often are you worried about your sexual life? 1 2 3 4 5

4. Are you bothered by any difficulties in your sex life? 1 2 3 4 5

5. How well are your sexual needs fulfilled? 1 2 3 4 5

IV. SATISFACTION IN LIFE 1. How satisfied are you with the quality of your life? 1 2 3 4 5

2. How much do difficulties with transport restrict your life?

1 2 3 4 5

3. To what extent are you hopeful about your life? 1 2 3 4 5


4. To what extent do you feel peaceful within yourself? 1 2 3 4 5

5. To what extent does faith contribute to your well-being? 1 2 3 4 5

V. TREATMENT SATISFACTION 1. How willing are you to take medications? 1 2 3 4 5

2. How much do you need any medication to function in your daily life?

1 2 3 4 5

3. How dependent are you on medications? 1 2 3 4 5

4. How satisfied are you about the present treatment? 1 2 3 4 5

5. How confident are you with the outcome of the treatment?

1 2 3 4 5

HEALTH PERCEPTION*

1. Compared to others of your age would you say your health is

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