annexure i ethical clearance of kle univeristy of higher...

Annexures

227

Annexure – I

Ethical Clearance of KLE Univeristy of Higher Education Belgaum

Annexures

228

Annexure – II

Plant Authentication Certificate

Annexures

229

Annexure – III

Animal Ethical Committee Clearance Certificate

Annexures

230

Annexure – IV

Ethical Clearnce certificate: BMK Ayurveda college & Hospital, Belgaum

Annexures

231

Annexures

232

Annexure - V

PRIOR INFORMED CONSENT FORM

Traditional Knowledge Dear Traditional Knowledge holder (s),

This research project ‘Role of Traditional Medicines in Reproductive Health’ is being

conducted by the research fellow Dr. Pushpa Kotur, under the mandate of RMRC

(ICMR) with the intention of documenting and developing the knowledge of herbal

practice. The initiative health will help in reducing the erosion of knowledge, increase

the social esteem of the grassroots innovators and knowledge providers and it will help

India become an innovative society. We strive to obtain the written consent and

authorization from all innovators/knowledge providers to disclose and/or add value to

innovation/traditional knowledge documented for the research project.

Reference No.:_________________________________________________________

Name of the Knowledge Holder: __________________________________________

Title of Traditional Knowledge/ Herbal practice:_____________________________

How did you know about the knowledge/practice?

a) Elders b) Self explored c) Family tradition d) Community

Please fill section A and C for box a, b, c and section B & C for box d

SECTION - A

A. Can your address be shared with those interested in your knowledge?

Yes No

B. Can your traditional knowledge be displayed/published on the Internet/ Scientific

journal?

Yes No

C. if yes, to what extent can your knowledge be shared?

a. Partial disclosure

OR

b. Full disclosure

D. Would you appreciate if further research is conducted on your traditional

knowledge?

If yes, please specify _____________________________________________________________________________________________________

_________________________________________________________________________________________________________________________

_________________________________________________________________________________________________________________________

Annexures

233

SECTION – B

A. Name of the community’s authorized leader

i. Elected _________________________

ii. Traditional ______________________

B. Can your address be shared with those interested in your knowledge?

Yes/ No

C. Can your traditional knowledge be displayed/published on the Internet/ Scientific

journal?

Yes No

D. If Yes, to what extent your knowledge be shared?

a) Partial disclosure

OR

b) Full disclosure

E. Whether the consent of the local community has been taken while submitting the

community traditional knowledge?

Yes No

F. To what extent specific traditional knowledge/ community knowledge is known and

or practical within or among the concerned communities?

(a)

(b)

G. Has the concerned community been informed of the improvement made in the

traditional knowledge belonging to them?

Yes No

Annexures

234

DECLARATION

I/ We have read this Prior Information Consent form and have understood the

implication of the various choices described in the explanatory note; I/ We have

voluntarily decided to select the option/options which I/ We have ticked above in

the section A and / or Section B. I/ We understand that if the Innovation /

Traditional Knowledge/ ideas provided to you is already well known and is in

public domain, then the restriction on its diffusion and application will not apply. I/

We further assure the researcher that all the information given above is true the b

my/our knowledge and belief.

_________________________

Signature

Name and Address of the Community/ Traditional Knowledge Holder:

_________________________________________________________________

_________________________________________________________________

__________________________________________________________________

_____________________

Signature

Name and Address of the of the Authorized Leader

_________________________________________________________________

_________________________________________________________________

__________________________________________________________________

_____________________

Signature

Name and Address of the Witness/collaborator

_________________________________________________________________

_________________________________________________________________

__________________________________________________________________

____________________________

Signature of theWitness

Date:__________________

Annexures

235

Annexure – VI

Questionnaire: Collection of Information from Traditional Practioner

Interview Schedule for Traditional Healers / Vaidyas

1. Name of the Practitioner / Vaidya / Local Healer:

______________________________________________________________________

2. Complete Address:

______________________________________________________________________

3. Age: Occupation:

4. Economical Status:

5. No. of Children:

Male Female

6. Place of Practice:

______________________________________________________________________

__

7. Experience (in years):

______________________________________________________________________

___

8. Practice Learnt by:

a. From forefathers

b. From others (Specify) _________________________________

c. By reading Books and gathering information.

d. Any other

9. Reason to start Practice:

a. Family business

b. Hobby / Interest

c. Any other

10. Is this your full time profession? Yes / No

11. Average no. of Patients treated per week

a. About 5 patients

b. 5 to 10 patients

c. 10 to 20 patients

d. More than 20 patients

12 Diseases you generally treat

a. ____________________ e. ____________________

b. ____________________ f. ____________________

c. ____________________ g. ____________________

d. ____________________ h. ____________________

Photo

Annexures

236

13. Are you specialized in treating particular disease?

________________________________________________________________

14. What type of people come to you for treatment?

15. How do you diagnose the condition? Explain methods of diagnosis.

16. In which phase of the disease your treatment is useful?

a. Emergency b. Acute c. chronic

17. From where do you collect the medicinal plants used by you? Do you follow

particular method of collection?

Please mention if particular season / time of the day for collection of the plants.

________________________________________________________________

________________________________________________________________

________________________________________________________________

19. How do you procure the medicinal plants used by you?

20. Which type of the plants do you procure? Wild Cultivated

21. Do you use stored or fresh medicinal plants? Fresh Stored

22. How do you store medicinal plants?

23. Have you ever thought of cultivating the plants used by you? If the your answer is

yes what are the conditions required to grow these plants?

________________________________________________________________

________________________________________________________________

24. Do you process / purify before prescribing the medicine? What are the dosages of

the medicines?

25 Which part of the plants do you use? What are the dosages of the medicines?

Disease Plant used Part of the plant Processing Details Dose

Annexures

237

26. Do you prescribe any animal product for treatment / prevention of diseases

Yes/No

If your answer is yes please provide the details

________________________________________________________________

________________________________________________________________

27. Do you advise any dietary or other restrictions to the patient during the course of

treatment? Please provide details.

________________________________________________________________

________________________________________________________________

28. What is the outcome of your treatment?

a. Good b. Very good c. Excellent d. Not so good

29. Have you observed any side effects, interactions of any of the medicinal Plant? If

the answer is yes in which type of patients it is more common and how do you tackle

them?

________________________________________________________________

________________________________________________________________

30. Do you use same medicinal dose/ mode of preparation for all age groups?

________________________________________________________________

________________________________________________________________

31. Do you get the plants in sufficient quantity for your practice? Yes/ No If no please

provide the reasons.

________________________________________________________________

________________________________________________________________

32. Do you get medicinal plants in sufficient quantity?

33. Do you document or keep records of your patients? Do you follow them regularly?

Yes/No

34. Do you want to preserve the heritage of herbal medicine?

Yes/No

35. Are you ready to share/teach the knowledge of herbal medicine to others?

Yes/No

36. What kind of remuneration you are getting from the patients?

37. Do you use any herbal product or medicine to keep yourself healthy and fit

(prevention)?

Annexures

238

Annexure – VII

Data Analysis Sheet

Sl.

No.

Plant

(Local

Name)

Specimen

Number

Part used &

condition

(Fresh/dry)

Quantity Preparation &

Utilization

Dose &

Duration

Disease Miscellaneous

Signature of the Interviewer Date

Annexures

239

Annexure – VIII

Acute toxicity study- Animal Behavioural Observation Chart

Annexures

240

Annexure - IX

Questionnaire to Find Out Prevalence of primary dysmenorrhea and

menstrual pattern in young female College students

Name of Student_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Name of College _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Class _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

______________________________________________________________________

1. How old are you?................................. Years

2. Your height: ………………..(cm) weight:…………………… (Kg)

3. How many siblings do you have?

a. only child b. 1-3 siblings c. 4 or more siblings

5. What is the educational level of your father?

a. Primary school b. Secondary school c. High school

d. College or university e. Literate

6. What is the educational level of your mother?

a. Primary school b. Secondary school c. High school

d. College or university e. Literate

6. Do you exercise? 1 Yes 2 No

7. Which exercise do you do? Please specify

8. Do you have a chronic disease which requires you to use medication regularly?

1 No 2 If Yes (write down the name of your

disease………….)

7. Have you ever had an operation?

No If Yes (write down the name of the operation you

underwent……)

8. What was your first menstruation age?

9. Do you have regular menstruations? Yes No

10. What is the frequency of your menstruations? Every…………………… days

11. Write down the duration of your menstruation period? (How many days do?

Annexures

241

Your period last?)………….days

12. Write down the age of your mother, (if she is alive):…………….. Years

13. Write down the first menstruation age of your mother, (if you know): years

14. Does mother have regular periods, as far as you know?

a. Yes b. No c. do not know d. in menopause

14. What is the source of your knowledge about menstruation?

a. Mother b. Friend/sister c. Family Doctor /nurse

d. Nobody e. Other (please specify)

15. Mark the complaints you have due to menstruation

a.Mood disorders Yes No

b. Fatigue Yes No

c. Bloated feeling Yes No

d. Daily activities restricted Yes No

e. Enhanced appetite Yes No

f. Loss of appetite Yes No

16. Do you have pain during menstruation?

a. Yes, in each period b. Yes in some periods

c. No

The survey has ended for those who answered 'NO' to question 16 If the

answer is 'Yes' fill up part II of questioner.

Please return to : Dr. Pushpa Kotur

Parwati Nursing Home,

Shivabasav Nagar

Belgaum Phone 831-2470159/2472058

Mobile: 9449287811

Annexures

242

Part II Questainner : (The survey continues for those who answered YES)

17. Since when have you been having painful menstruation?

a. Since my first period b. For the last………..... months

c. For the last ……………..years

18. On which day of your period does the pain start?..........................

19. How long does it last?

a. 1 day b. 2 days c. 3days d.4 days /more

20. Do you take analgesic drug for menstrual pain?

No If Yes (indicate the name of the drug:…………)

21. Does your menstruation pattern change when you take analgesic drug?

No If Yes (Please specify the change: …………….)

22. Have you ever seen a doctor for menstrual pain? Yes No

23. Have you ever missed any school day due to menstrual pain in the last year?

a. Never b.1 day c.2days

d. 3-4 days e. 5-6 days f. 7 days or more

24. Have you ever missed any examinations due to menstrual pain in the last year?

a. Never b. Once c. Twice d. Three times or more

25. How do you evaluate your school performance when you have painful

menstruation?

a. Very poor b. Poor c. Average

d. Good e. Very good

26. How do you evaluate your life performance when you have painful menstruation?

a. Very poor b. Poor c. Average

d. Good D e. Very good

27. How would you rate your menstrual pain on a scale from 1 to 10?

Please indicate 0 1 2 3 4 5 6 7 8 9 10

Please return to : Dr. Pushpa Kotur

Parwati Nursing Home, Shivabasav Nagar

Belgaum Phone 831-2470159/2472058, Mobile: 9449287811

Annexures

243

Annexures

244

Annexures

245

Annexures

246

Annexure - XI

INFORMED CONSENT FORM

Investigator: Dr. Pushpa Kotur

Name of the participant;

Mrs / Mr.____________________________________________________ Age

_____________Y rs.

Reg. No. ___________________________

I, Dr. Pushpa Kotur, research fellow, KLE University, Belgaum, request you to be a

participant in the research study titled 'Role-of Traditional Medicine in Reproductive

Health' conducted by me (as a requirement to be fulfilled as a part of my Ph.D.

programme).I request you to read this form and ask questions ,if you have any, regarding

the study prior to signing this form. I am herewith submitting details of the research

protocol as follows:

Aim of The Study: to evaluate the herbal medicines used by the traditional healers in rural

area of Belgaum District.

Purpose of research:

1. To document and develop knowledge of herbal practice and their effective use in

reproductive health care.

2. To evaluate advantages, efficacy, and safety of these herbal practice

Procedure involved:

You will be examined and investigated for your reproductive l1ealth problems. During this

procedure your blood and urine sample may be required to diagnose the nature of disease.

You may be subjected for ultrasonic examination to confirm the diagnosis. Further you will

be offered the herbal medicine to treat your disease/ disorder as per the formulation of the

traditional healer's directions. During the course of treatment you may be advised dietary

restrictions or other form of restrictions.

Once the course of the treatment is over you will be again interviewed to find out the

outcome of the treatment modality. Again you may be subjected to examination and

investigations to document the efficiency, safety of the treatment modality.

Potential risks and discomfort: I would like to quation you that you may be sensitive to

the herbal medicine; more so if you are using some other drugs for the treatment of the

same or some other disease/ disorder because there may be risk of drug interaction in

such situations. Hence I request you to inform us regarding the drugs other than medicine

prescribed by us being used by you during the course of this treatment.

Benefits of participating this research project:

Please note that you will be treated under the supervision of the expert qualified medical

personnel although you have opted for traditional herbal medicine. If you have any side

effects of the herbal medicines, they will be promptly treated, free of cost, in a scientific

manner.

You will be helping to document and apply this knowledge of herbal medicine in a

scientific manner to treat other patients with similar problems in the community.

Annexures

247

New Information:

Any new information collected will be told to you as and when required.

Privacy and confidentiality:

I would like to assure you the privacy and confidentiality will be respected and any

information provided by you or collected during the study will be kept strictly confidential.

Injury as a result of participation:

I will like to state that there will neither be any compensation to you and your relatives nor

there any monitory benefits for the damage incurred during the course of study.

Costs of participation in this research:

Please note that participation is free of cost.

Reimbursement for any expenditure for participation:

There will not be any reimbursement for any of your expenditure.

Withdrawal for any expenses for participation in research:

Please note that to start with the as participation is voluntary so is the decision to withdraw.

I would assure you that such step will not alter the participant's management by any of the

staff of the institution. Kindly note that researcher can remove you from the study if such

circumstances arise.

Whom to contact:

Kindly feel yourself free to enquire about any queries or information regarding the research

project during the study or even thereafter. If required you can contact following persons:

Dr. Pushpa. P. Kotur.

Research fellow, KLE University, Belgaum.

44/Sector 2, Shivabasav Nagar, Belgaum. Phone 9449287811

Dr. S. D. Kholkute. Dy. Director, Regional Medical Research Centre (ICMR), Belgaum

Cell : 9448366539

Dr. B. Srinivasa Prasad. Principal, K.L.E.S. B. M. Kankanwadi Ayurveda Medical College,

Belgaum

Cell :9448569289

Signature of the participant/legally authorized person:

Participant's name:

Signature:

Witness name:

Signature:

Date: Place:

Annexures

248

Annexure - XII

PHASE III A: LIMITED CLINICAL EVALUATION OF HIBISCUS

ROSA SINENSIS L. (WHITE FLOWERS) USED FOR THE

TREATMENT OF VULVO VAGINITIS

PROFORMA

I. Personal History

Intials of the Patient: Age:

Address:

Occupation:

II. Gynaecological complaints:

1. Menstrual Disorders: Duration

a. Menorrhagia b. Hypomenorrhoea

c. Dysmenorrhoea d. Premenstrual Symptoms

e. Menstrual Irregularities:

i. Metrorrhagia

ii. polymenorrhoea

iii. oligermenorrhoea

2. White discharge P/V

3. Blood Stained Discharge

4. Infertility.:

Primary Secondary .

5. Other complaints

Annexures

249

II . Present Menstrual History:

III . Past Menstrual History:

IV . Obstetric History:

1. No.of Deliveries : FTND PTD

2. No. of Abortions:

3. Causes of Abortions :

4. Last Delivery:

5. Underwent Sterilisation:

6. How many Years Back?

V . Past History :

1. H/O Similar Complaints:

2. Duration of Complaints:

3. Diagnosis :

4. Investigations :

5. Treatment Taken :

VI . Medical History :

1. Tuberculosis : 2. Thyroid Disorder:

3. Bleeding Disorder: 4. Hypertension:

5. H/O taking Treatment Duration

Medicines— 1.

2.

3.

4.

6. H/O Surgery in the past

Type of Surgery:

Annexures

250

When?

Post- Operative Medicines:

VII .General Physical Examination:

HT. WT. Nutritional Status:

Temp.: Pulse Resp. Rate:

B.P.: Oedema: Anaemia:

VIII . Systemic Examination:

Cardiovascular

Respiratory:

Per Abdominal:

Per Speculum:

Per Vaginal :

P/R.

IX . Provisional Clinical Diagnosis :

X. Investigations :

Before Treatment After Treatment

1. Hb%

2. T/C

3. Diff Count.

Annexures

251

4. ESR.

5. Urine Analysis

6. RBS

7. BUN.

8. Serum Creatinine

9. Ultrasonography:

10. Pap Smear:

11. Vaginal Smear:

PH

KOH : Fishy Odour Yes No

Wet Smear Trichomoniasis Candidiasis

12. Culture Sensitivity:

High Vaginal Swab

Cervical swab

XI .Final Diagnosis:

XII . Treatment :

Herbal

Conventional : Required Not required

XII . Reassessment and Follow Up:

1. Vaginal Smear:

PH

KOH : Fishy Odour Yes No

Wet Smear Trichomoniasis Candidiasis

2. Culture Sensitivity:

High Vaginal Swab

Cervical swab

Annexures

252

Annexure - XIII

PHASE III B: LIMITED CLINICAL EVALUATION OF LEAVES

AND STEMS OF OCIMUM BASILICUM L. USED FOR THE

TREATMENT DYSMENORRHOEA.

PROFORMA

I. Personal History

Intials of the Patient: Age:

Address:

Occupation:


1 Menstrual Disorders: Duration

a. Menorrhagia b. Hypomenorrhoea

c. Dysmenorrhoea d. Premenstrual Symptoms


i. Metrorrhagia

ii. polymenorrhoea

iii. oligermenorrhoea



4. Infertility.:

Primary Secondary .

5 Other complaints


Annexures

253






10. Last Delivery:



V . Past History :



8. Diagnosis :

9. Investigations :






Medicines— 1.

2.

3.

4.


Type of Surgery:

When?


Annexures

254






Cardiovascular

Respiratory:

Per Abdominal:

Per Speculum:

Per Vaginal :

P/R.


X. Investigations :


13. Hb%

14. T/C

15. Diff Count.

16. ESR.

17. Urine Analysis

18. RBS

19. BUN.

Annexures

255

20. Serum Creatinine

21. Ultrasonography:


XII . Treatment :

Herbal

Conventional : Required Not required


VAS Score:

PBLAC Score :

Hb% :

Side Effects: Acceptance

Annexures

256

Annexure – XIV

Visual Analysis Scale (VAS) Score Chart

Annexures

257

Annexure – XV

Annexures

258

PHASE III-C: LIMITED CLINICAL EVALUATION OF HIBISCUS

ROSA SINENSIS L. (RED FLOWERS) USED FOR THE

TREATMENT OF DYSFUNCTIONAL UTERINE BLEEDING.

PROFORMA

I. Personal History

Intials of the Patient:

Age:

Address:

Occupation:


1. Menstrual Disorders: Duration

a. Menorrhagia b.Hypomenorrhoea

c Dysmenorrhoea d. Premenstrual Symptoms


i) polymenorrhoea ii) oligermenorrhoea

f. Metrorrhagia



4. Infertility.:

Primary Secondary

.

5. Other complaints

Annexures

259







4. Last Delivery:



V . Past History :



3. Diagnosis :

4. Investigations :






Medicines— 1.

2.

3.

4.

Annexures

260


Type of Surgery:

When?







Cardiovascular

Respiratory:

Per Abdominal:

Per Speculum:

Per Vaginal :

P/R.


X. Investigations :


1. Hb%

2. T/C

3. Diff Count.

4. ESR.

Annexures

261

5. Urine Analysis

6. RBS

7. BUN.

8. Serum Creatinine

9. Ultrasonography:

10. Pap Smear:

11. Endometrial Biopsy


XII . Treatment :

Herbal

Conventional :


PBLAC Score :

Hb% :

Side Effects:

Acceptance

annexure i ethical clearance of kle univeristy of higher...

Documents