RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

ANNEXURE-II APPLICATION FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. NAME OF THE CANDIDATE

AND ADDRESS

Dr FERNANDES SAVIONA

DEPARTMENT OF MATERIA MEDICA,

FATHER MULLER HOMOEOPATHIC

MEDICAL COLLEGE AND HOSPITAL,

UNIVERSITY ROAD,DERALAKATTE,

MANGALORE-575018.

KARNATAKA.

PERMANENT ADDRESS Dr FERNANDES SAVIONA

H. NO-129

NEAR CONCEPTION CHAPEL

PORTAIS- RIBANDAR

GOA- 403006

2. NAME OF THE

INSTITUTION

FATHER MULLER HOMOEOPATHIC

MEDICAL COLLEGE AND HOSPITAL,

DERALAKATTE,

MANGALORE.

3. COURSE OF THE STUDY

AND SUBJECT

M D.(HOM)

MATERIA MEDICA.

4. DATE OF ADMISSION TO

THE COURSE

25.05.2010.

5. TITLE OF THE TOPIC

“A STUDY ON THE EFFICACY OF GYMNEMA SYLVESTRE ON BLOOD

GLUCOSE LEVELS IN TYPE II DIABETES MELLITUS”

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6. BRIEF RESUME OF THE INTENDED WORK

INTRODUCTION

Diabetes is a major public health problem and is emerging as a pandemic.

There are about 171 million people with diabetes in this world 1. India has a high

prevalence of diabetes mellitus and the numbers are increasing at an alarming rate.

In India alone, diabetes is expected to increase from 40.6 million in 2006 to 79.4

million by 2030. Studies have shown that the prevalence of diabetes in urban

Indian adults is about 12.1%, the onset of which is about a decade earlier than their

western counterparts and the prevalence of Type 2 diabetes is 4-6 times higher in

urban than in rural areas 2.

Diabetes has been called the silent killer; it kills joy, the insidious enemy.

The word diabetes is originated from Latin, where Diab- flow through mell= sweet

urine. Diabetes is sweet urine passing through our body 3. Statistical analysis for

diabetes mellitus reveals the hereditary preponderance along with lifestyles and

food habits .The risk factors peculiar for developing diabetes among Indians

Include high familial aggregation, central obesity, insulin resistance and life style

changes due to urbanization. Screening for gestational diabetes and impaired

glucose tolerance among pregnant women provides a scope for primary prevention

of the disease in mothers as well as in their children. The problems of obesity and

impaired glucose tolerance (IGT) (important predisposing factors) are not confined

to adults alone but children are also increasingly getting affected. Most long

standing macro and micro vascular complications are also more common among

Indian diabetics as compared to other races and ethnic groups. A strong familial

clustering of diabetic nephropathy among Indian Type 2 diabetics has also been

noted. Clustering of cardiovascular risk factor like Syndrome X is common among

urban Indians. The rising incidence of diabetes and its complications are going to

pose a grave health care burden on our country 2.

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6.1 NEED FOR STUDY:

The existing medical treatment aims at correcting the disturbance at

receptor level, enhancing the glucose uptake by administering drugs corresponding

to it, here comes factors like cost effectiveness, sensitiveness and also drug

dependency, so it provides an opportunity to prove the efficacy of homoeopathy in

treating chronic diseases, thereby proving homoeopathy to be a better system in

treatment like diabetes mellitus. Homoeopathy being a medical system with

holistic approach has a comprehensive treatment plan, which is not only limited to

glycemic control alone, but also minimizing or preventing the progress of diabetes

mellitus. The constitutional and organ specific remedies have played a good role in

minimizing the complication and improving the sense of well being as a whole.

One of the common difficulties faced by homoeopathic physicians is to

bring down the raised blood sugar level in a short span of time. Though

constitutional medicine is the best specific in diabetes, its identification and dosage

selection requires more time and experience. In such situations homoeopathic

mother tinctures are used, because of its instant physiological action. Mother

tinctures are utilized when the totality of symptoms is not indicating a clear cut

remedy. Many times diabetics present with paucity of symptoms, and

constitutional medicine cannot be derived. Hence in such conditions mother

tinctures can be administered. Few mother tinctures have been clinically tried and

tested for their efficacy in Diabetes Mellitus.

In homoeopathy more and more detailed evidence based study is

required in diabetes mellitus, especially in reducing blood glucose levels with the

help of mother tinctures like Gymnema Sylvester, Abroma, Cephalandra,

Synzygium jambolanum etc.

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There is not much evidence on the utility of the drug Gymnema; hence I

have undertaken this study, to demonstrate the role of Gymnema Sylvester, in

reducing the blood glucose levels in non insulin dependent Diabetes mellitus.

6.2 REVIEW OF THE LITERATURE:

The term diabetes, without qualification, usually refers to diabetes

mellitus, which roughly translates to excessive sweet urine (known as

"glycosuria"). Diabetes was described more than 2000 years ago. For the past

200yrs, it has featured in the history of modern medicine. Since diabetes mellitus

is a world problem, all nations- both developed and developing, now recognize the

need for attention to the problem 4. Diabetes is a clinical syndrome characterized

by hyperglycemia due to absolute or relative deficiency of insulin; this can arise in

many different ways, but most commonly due to autoimmune, type 1 diabetes or to

adult onset, type 2 diabetes 5.

Type 2 diabetes mellitus is characterized by insulin resistance which

may be combined with relatively reduced insulin secretion. The defective

responsiveness of body tissues to insulin is believed to involve the insulin receptor.

However, the specific defects are not known. Diabetes mellitus due to a known

defect are classified separately. Type 2 diabetes is the most common type.

In the early stage of type  2 diabetes, the predominant abnormality is

reduced insulin sensitivity. At this stage hyperglycemia can be reversed by a

variety of measures and medications that improve insulin sensitivity or reduce

glucose production by the liver 6.

Signs and symptoms

The classical symptoms of diabetes are polyuria (frequent urination),

polydipsia (increased thirst) and polyphagia (increased hunger). Symptoms in

type 2 diabetes they usually develop much more slowly and may be subtle or

absent 6.

Prolonged high blood glucose causes glucose absorption, which

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leads to changes in the shape of the lenses of the eyes, resulting in vision changes;

sustained sensible glucose control usually returns the lens to its original shape.

Blurred vision is a common complaint leading to a diabetes diagnosis; type 1

should always be suspected in cases of rapid vision change, whereas with type 2

changes are generally more gradual, but should still be suspected 6.

A rarer but equally severe possibility is hyperosmolar nonketotic

state, which is more common in type 2 diabetes and is mainly the result of

dehydration. Often, the patient has been drinking extreme amounts of sugar-

containing drinks, leading to a vicious circle in regard to the water loss. A number

of skin rashes can occur in diabetes that is collectively known as diabetic

dermadromes 6.

CAUSES

Type 2 diabetes is primarily due to lifestyle factors and genetics 5.

PATHOPHYSIOLOGY

Insulin is the principal hormone that regulates uptake of glucose from the

blood into most cells (primarily muscle and fat cells, but not central nervous

system cells). Therefore deficiency of insulin or the insensitivity of its receptors

plays a central role in all forms of diabetes mellitus. Higher insulin levels increase

some anabolic ("building up") processes such as cell growth and duplication,

protein synthesis, and fat storage. Insulin (or its lack) is the principal signal in

converting many of the bidirectional processes of metabolism from a catabolic to

an anabolic direction, and vice versa 6.

In particular, a low insulin level is the trigger for entering or leaving

ketosis (the fat burning metabolic phase).

If the amount of insulin available is insufficient, if cells respond

poorly to the effects of insulin (insulin insensitivity or resistance), or if the insulin

itself is defective, then glucose will not have its usual effect so that glucose will

not be absorbed properly by those body cells that require it nor will it be stored

appropriately in the liver and muscles. The net effect is persistent high levels of

blood glucose, poor protein synthesis, and other metabolic derangements, such as

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acidosis. When the glucose concentration in the blood is raised beyond its renal

threshold (about 10 mmol/L, although this may be altered in certain conditions,

such as pregnancy), reabsorption of glucose in the proximal renal tubuli is

incomplete, and part of the glucose remains in the urine (glycosuria). This

increases the osmotic pressure of the urine and inhibits reabsorption of water by

the kidney, resulting in increased urine production (polyuria) and increased fluid

loss. Lost blood volume will be replaced osmotically from water held in body cells

and other body compartments, causing dehydration and increased thirst 6.

Diabetes mellitus is characterized by recurrent or persistent

hyperglycemia, and the new diagnostic criteria for diabetes mellitus have been

greatly simplified.

Criteria for the diagnosis of diabetes mellitus 7

1. Symptoms of diabetes plus casual plasma glucose concentration ≥200

mg/dl (11.1 mmol/l). Casual is defined as any time of day without regard to

time since last meal. The classic symptoms of diabetes include polyuria,

polydipsia, and unexplained weight loss.

2. FBG ≥126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for

at least 8 h.

3. 2-hr post load glucose ≥200 mg/dl (11.1 mmol/l ) during an OGTT. The

test should be performed as described by WHO, using a glucose load

containing the equivalent of 75 g anhydrous glucose dissolved in water.

In the absence of unequivocal hyperglycemia, these criteria should be

confirmed by repeat testing on a different day. The third measure (OGTT) is not

recommended for routine clinical use 7.

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COMPLICATIONS 5 :

Microvascular/ neuropathic complications-

1. Retinopathy, cataract

Impaired vision

2. Nephropathy

Renal failure

3. Peripheral neuropathy

Sensory loss

Motor weakness

4. Autonomic neuropathy

Postural hypotension

Gastrointestinal problems/ altered bowel habits

5. Foot disease.

Ulceration

Arthropathy

Macrovascular

1. Coronary circulation

Myocardial ischemia/ infarction

2. Cerebral circulation

Transient ischemic attack

Stroke

3. Peripheral circulation

Claudication

Ischemia 5.

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MANAGEMENT

Three methods of treatment are available for diabetic patients.

Diet and lifestyle advices, oral hypoglycemic medications, insulin.

HOMEOPATHIC APPROACH

Constitutional remedies are the best remedies in treating the patient. In case where

in there is paucity of symptoms, or constitutional picture is not clear we can think

of specific remedy. Some of the specifics used are Gymnema Sylvester,

Synzygium jambolanum, Abroma Augusta, Cephalandra indica, Datisca Canabina,

Okoubaka, Rhus aromatic, Vincetonion, Chionanthus .8.

In this study I have considered Gymnema, to know its action on blood glucose

levels.

GYMNEMA SYLVESTRE

Botanical name: Gymnema Sylvester R. Br 9

Family: Asclepiadaceae 9

Common name: Gurma, Mesharingi 10

Proved by: Lt. Col. R. N. Chopra 10

Is an herb native to the tropical forests of southern and central India. It has

been used as a naturopathic treatment for diabetes for nearly two millennia 11.

Description

Large climbers, young stems and branches terete, pubescent. Leaves sub-

coriaceous, 2.5- 6cms long, elliptical or ovate, acute or shortly acuminate, cuneate

rounded or cordate at base. Flowers small, in axillary and lateral umbel like cymes,

pedicels long; Calyx-lobes long, ovate, obtuse, pubescent; Corolla pale yellow

corona single, with 5 fleshy scales. Corolla lobes protrude beyond the sinuses.;

Anther connective produced into a membranous tip, style- apex axserted. Follicles

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2.5-7.5 cm. long, glabrous, lanceolate, tapering into a beak. Seeds 12mm long,

narrowly ovoid- oblong, flat and broadly margined, pale brown. 9

Active principle: Gymnemic acid 11

Chemical composition

The major bioactive constituents of Gymnema sylvestris are a group of

oleanane type triterpenoid saponins known as gymnemic acids. The latter contain

several acylated (tigloyl, methylbutyroyl etc.,) derivatives of deacylgymnemic acid

(DAGA) which is 3-O-glucuronide of gymnemagenin (3, 16, 21, 22, 23, 28-

hexahydroxy-olean-12-ene) 2. The individual gymnemic acids (saponins) include

gymnemic acids I-VII, gymnemosides A-F, gymnemasaponins 11.

Gymnemic acids have antidiabetic, astringent, antisweetener and anti-

inflammatory activities. The antidiabetic array of molecules has been identified as

a group of closely related gymnemic acids after it was successfully isolated and

purified from the leaves of Gymnema sylvestre11.

While it is still being studied, and the effects of the herb are not

entirely known, the herb has been shown to reduce blood sugar levels when used

for an extended period of time. Additionally, Gymnema reduces the taste of sugar

when it is placed in the mouth, thus some use it to fight sugar cravings. From

extract of the leaves were isolated glycosides known as Gymnemic acids, which

exhibit anti-sweet activity.

Parts used: leaves 9

9

The drug acts by bringing about blood homoeostasis through increased

serum insulin levels provided by repair presentation of the pancreas14.

Ayurvedic use: it is used as astringent, stomachic, tonic and refrigerant,

antihelmentic, useful in eye complaints, cures opacities of lens good in diseases of

heart, piles, leucoderma, biliousness, bronchitis, asthma, ulcers. It is useful in

poisonous styes and headache due to catarrh and also glycosuria. The plant has

been described as an antiperiodic, stomachic and diuretic 12.

Toxicology: little is known about long term safety of the plant, but it generally has

not been associated with human toxicity 14.

Potential drug interaction15:

Action is enhanced by

Anti depressant medication Salicylates (aspirin) Tetracycline’s

Action is decreased by use of

Epinephrine Phenothiaziades Thyroid hormone

Homoeopathic use

Urine: profuse urination loaded with sugar. After passing of urine, patient

exclaims, this passing of urine in large amounts has made me very weak. Color of

urine is white, quantity is copious, specific gravity is high, large amount of sugar is

found in urine 10.

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Skin: there is burning all over the body, boils and carbuncles burn, diabetic

carbuncle may appear anywhere in the body 10.

Sexual organs: weakness of sexual power.

Generalities: enables weight loss by altering metabolism and suppressing appetite.

It reduces body’s ability to taste sweetness. It acts as a natural anti- inflammatory

when applied in powdered form o a snake bite, helps to heal the wound. Reduces

total cholesterol and triglyceride level. Used to treat stomach disorders,

constipation, high and low blood pressure, anemia and liver diseases, tachycardia,

arrhythmia and weight gain

Usually used in mother tincture, 3X and 6 10.

6.3 OBJECTIVES OF THE STUDY:

1. To study the effect of Gymnema sylvestre in controlling blood glucose

values.

2. To compare the action of mother tincture and 6X.

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7.MATERIALS AND METHODS

7.1 SOURCE OF DATA:

The subjects will be selected from OPD, IPD and peripheral centers of

Father Muller Homoeopathic Medical College, Mangalore.

7.2 METHOD OF COLLECTION OF DATA:

A sample of minimum 60 cases will be selected based on symptom

similarity. Cases will be followed for a minimum period of 4- 6 months. Minimum

30 cases each will be selected each for mother tincture and 6 X scales.

Fasting blood sugar level of < 200 - 10 drops and > 200 - 20 drops of mother

tincture. And for the 6X potency, 4 pills thrice a day will be given.

INCLUSION CRITERIA:

1. The sample is taken from both the sexes of age 30-75.

2. Cases not improving with constitutional treatment

EXCLUSION CRITERIA:

1. Type I diabetes

2. Patient with other systemic illnesses.

RESEARCH HYPOTHESIS:

Gymnema sylvestre helps in reducing the blood glucose levels.

PLAN FOR DATA ANALYSIS:

The collected data will be analyzed by Paired ‘T’ test and unpaired ‘T’

test.

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7.3 Does the study require any investigations to be conducted on patients, or

other humans (or animals)? If so please describe briefly.

Yes, Fasting blood sugar levels , Post Prandial or random blood sugar

levels needs to be done at regular intervals.

7.4 Has ethical clearance been obtained from your institution in case of 7.3?

Yes, enclosed.

8.

LIST OF REFERENCES

1. Jayaram BM. Type 2 diabetes and its complication- a preventive

programme. p. 1-3

2. Lt Gen Mehta SR, Lt Gen Kashyap AS, Lt Col Das S. Diabetes mellitus

in India: the modern scourge. [serial online] 2009.[cited MJAFI 2009]; Vol.

65( No. 1), [ p.50-54] available from :URL:

http://medind.nic.in/maa/t09/i1/maat09i1p50.pdf

3. Mathur Ruchi MD. Diabetes mellitus. [Online] available from :URL:

http://www.medicinenet.com/diabetes_mellitus/article.htm

4. Khan Ronald C, Weir C Gordon. Joslin’s Diabetes Mellitus. thirteenth ed.

B.I. Waverly Pvt Ltd. p. 1,12

5. Davidson’s. Principles and practice of medicine. 20th edition 2006.

Published by Churchill Livingstone. p. 808

6. Diabetes mellitus. Wikipedia the free encyclopedia. available from :URL:

http://en.wikipedia.org/wiki/Diabetes_mellitus

7. http://care.diabetesjournals.org/content/27/suppl_1/s5/T2.expansion.html

8. Varma and Yadav Kusum PN, Ashok Kumar. Schwabe’s a compendium

of rare and clinically established mother tinctures. Second ed. published by

13

Willmar Schwabe India Ltd.

9. Homoeopathic pharmacopoeia of India (HPI). First ed .published by

Government of India- Ministry of health. p.129 ( ;vol 1).

10. Boericke William. Pocket Manual of Homeopathic Materia Medica &

Repertory and a chapter on rare and uncommon remedies. Reprint ed 2004,

New Delhi, B Jain Publishers Pvt Ltd; p. 1062.

11. Gymnema sylvestre. Wikipedia the free encyclopedia available from :URL:

http://en.wikipedia.org/wiki/Gymnema_sylvestre

12. Nadkarni K M . Indian material medica. Reprinted ed1998; Published by

popular Prakashan Pvt. Ltd; (Vol 1): p. 596-597

13. Seshiah V. A handbook on diabetes mellitus. second ed. p. 23

14. http://www.himalayahealthcare.com/herbfinder/h_gymnem.htm

15. Susan G Wynn, Barbara Fougère. Veterinary herbal medicine. Published in

Google Books.

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9. SIGNATURE OF

THECANDIDATE

10. REMARKS OF THE GUIDE

11. 11.1 NAME AND

DESIGNATION OF GUIDE

(IN BLOCK LETTERS)

Dr SUNNY MATHEW,

MD (Hom.)

PROFESSOR,DEPARTMENT OF

HOMOEOPATHIC MATERIA MEDICA

FMHMC, DERALAKATTE,

MANGALORE

11.2

SIGNATURE

11.3 CO – GUIDE

11.5 HEAD OF THE

DEPARTMENT

Dr SRINATH RAO

MD (HOM.)

PROFESSOR,DEPARTMENT OF

HOMOEOPATHIC MATERIA MEDICA

FMHMC, DERALAKATTE,

MANGALORE

11.6 SIGNATURE

12. 12.1 REMARKS OF THE

CHAIRMAN AND

PRINCIPAL

12.2 SIGNATURE

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