Clinical Research Protocols for Traditional Health Sciences.475-496

8/16/2019 Clinical Research Protocols for Traditional Health Sciences.475-496

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Drug : Study Code:

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA

AND SIDDHA

RANDOMISED DOUBLE BLIND CONTROLLED

CLINICAL TRIAL OF AYUSH-DIAB IN CONTROLLING

BLOOD SUGAR LEVEL IN Type 2 DIABETES

MELLITUS

PROTOCOL & CASE REPORT FORMS (CRF)


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I. BACKGROUND

Diabetes is a metabolic disorder; a comparable condition of Madhumeha specifically an

abnormality in the way of the body utilizes glucose, due to an absolute or relative deficiency of the

hormone insulin or resistance by the body tissues to the action of insulin.

Conventional modern medicine provides a number of drug of choice for controlling the

blood sugar level in the patients of diabetes mellitus type-2. However, with the prolonged

treatment doses of the drugs often needs to be increased to control the blood sugar level and a

time comes when patient has to be switched over to insulin. Such patients become cases of insulindependent diabetes mellitus. With a view to help the suffering community there is a need to find a

safer drug, which can be used to control the blood sugar level and such drug can be used safety

for longer periods.Ayurvedic classics provide references on herbal and herbo-mineral preparations

which can be safely used in controlling the blood sugar level in the patients of diabetes mellitus.1

II. OBJECTIVE

To study the effect of Ayurvedic formulation in controlling blood sugar level of the patients

suffering with Type-2 Diabetes mellitus.

III. CENTRE

Identified Centres of CCRAS

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA

RANDOMISED DOUBLE BLINDCONTROLLED CLINICAL TRIAL OF AYUSH-

DIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2 DIABETES

MELLITUS

References

1. Harrison’s Principle of Internal Medicine 15th Edition Page 2109-2135.

2. The Expert Committee on the Diagnosis and classification of Diabetes Mellitus : Report of the

Expert Committee on Diagnosis Classification of Diabetes Mellitus, Diabetic care 1997;

207:1183-97.

3. Siddharth N Shah, Asshit Shah, API Text Book of Medicine 5th Edition Page-1460.

4. Vaisajya Ratnawali, Saptam Sanskaran 2040 Page 812.


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IV. SAMPLE SIZE AND METHODS

Sample Size-100

Total Number of group-Two

Total number of patients in each group-50

Level of study-OPD

Treatment:

A. Dietary regimen: Patient will be advised to restrict their dietary schedule and do

light exercises (like brisk walking for two kms. per day, swimming, jogging etc.

during treatment).

B. Trial drug:

1. Ayush-DIAB 500 mg dragees BD with water half hrs before meals (Capsule

Ayush-DIAB contained extracts of Meshashringi (leaves) one part+ Amra Beeja

Majja one part + Karvelaka Beeja one part + Jambu Beeja one part + Silajeeta

one part) for six months.

Diet: -Patients will be advised to take their diet as described in Patient information sheet

and do brisk walking/jogging or light exercise for half hour daily..

2. Standard control: Glimepiride 1mg OD ½ hour before meal.

Duration of the study: Six months (total duration of the study 2 years)

Duration of medication - Six months

Total duration of study – 2 years

V. CRITERIA FOR INCLUSION

1. Age between 30 years to 65 years

2. If yes in any of the three

Blood sugar – Fasting > 126 and =< 200 mg/dl or

PP > 200 mg/dl and 7% and


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VI. CRITERIA FOR EXCLUSION

1. Age below 30 and above 65 years.

If yes in any of the three

Blood sugar – Fasting =< 126 and > than 200 mg/dl or

PP=< 200 mg/dl >350 mg/dl or

Glycated haemoglobin10%

2. Malignant and accelerated hypertensive

3. CVS disorder (CAD)

4. Pregnant woman and planning to be pregnant within six months

5. Lactating mother

6. Secondary Diabetes mellitus

7. Patient under going regular treatment for Diabetes or any other severe illness

8. CNS disorder e.g. encephalopathy

VII. CRITERIA FOR WITHDRAWAL

The investigator shall withdraw the patients from the study if

1. Fasting blood sugar rises to >200 mg. /dl. Or post prandial blood sugar level increasesto>350 mg./dl and are not controllable within fifteen days.

2. Any serious complication develops which requires urgent treatment with any other drug/

therapy?

The investigator will mention the probable cause of withdrawal and provide possible

medical treatment to manage the illness.

VIII. ROUTINE EXAMINATION AND ASSESSMENT

The full details of history and physical examination of the patients will be recorded as per the

proformae (Forms I & IA). Clinical and physiological assessment will be done before drug

administration and after every two weeks. The laboratory investigations will be recorded before drug

administration, after every two weeks (blood Sugar only) and at the end of treatment (Form-III)

IX. CRITERIA FOR ASSESSMENT

If during treatment or after treatment fasting Blood sugar becomes


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X. STATISTICAL ANALYSIS

Data on Fasting/Post prandial blood sugar and HbA1c will be analyzed using appropriate

statistical methods.

XI. TRIAL MONITORING AND DATA ANALYSES

The progress of the trial will be monitored by CCRAS Hqrs. New Delhi consisting of one

expert each of allopathy and Ayurveda besides one outside expert. Data analysis will be

undertaken at the Monitoring Unit CCRAS Hqrs. New Delhi

XII. ETHICAL REVIEW

A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee (IEC)

of trial center for getting clearance certificate before the project is initiated. Patient’s

information sheet and informed consent form will be submitted along with project proposal

for approval by EC. Both will be maintained in duplicate with one copy given to thepatient at the time of entry to the trial.

B. Data and safety monitoring board : A Data and safety monitoring board (DSMB) at

Hqrs. will carefully monitor the data and side effects during the period of study and put in

a place where by prompt reporting of adverse events occur. The data will be reviewed as

every 20 participants entered the study and administered the trial drugs. The research

team will report immediately to the PI and Data Monitoring Board if, any life threatening

conditions whether they are perceived to be study related or not. The Board decides

whether the adverse effects warrant discontinuation of the study protocol. Protocols will be

written and approved for the treatment of study related adverse events.

XIII. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED

Short-term two-day training will be provided to the Investigators and Laboratory

personnel involved in the multi-centric trial at CCRAS Hqrs. The investigators and technicians will

be detailed about the clinical trial conduct and laboratory procedures in order to maintain the

uniformity.

XIV. LABORATORY INVESTIGATIONS

The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at

research Institutes should be conducted at identified reputed labs /Government Institutes under

intimation to this Council following codal formalities.


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RANDOMISED DOUBLE BLIND CONTROLLED CLINICAL TRIAL OF

AYUSH-DIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2

DIABETES MELLITUS

CONSENT FORM

CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by

the patient.

Date: _______________ Signature of the Investigator: ___________

Name of Investigator: ________________

CONSENT BY SUBJECT

I have been informed to my satisfaction, by the attending physician, the purpose of the

clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations

to be performed 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.

I, exercising my free power of choice, hereby give my consent to be included as a subject

in the clinical trial on Randomized Controlled Clinical Trial of Ayush-DIAB Capsules in the

Controlling Blood Sugar Level in Type 2 Diabetes mellitus.

Date:___________ Name of the Subject:_____________________________

Signature or Thumb impression_____________________

Date:___________ Name of witness: _______________________________

Signature or Thumb impression: _____________________

Relationship ___________________________________

To be translated into regional language.


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Are there any risks?

Both trial and control drugs may cause hypoglycemia (very low blood sugar) in some

cases. The symptoms of hypoglycemia are sweating, drowsiness, nausea, confusion and in-

coordination. In case of such symptoms, you should immediately take sugar, glucose/biscuits and

milk/fresh lime juice/orange juice with sugar and report to the doctor.

What are the alternatives?

Your doctor will be pleased to explain to you the available alternative treatment to control

your blood sugar?

When you leave can the study?

Your participation in the study is entirely voluntary. You can choose to leave the study at

any time. Your decision to leave the study will not affect your medical care or relationship with

your doctor.

Your doctor may decided that you should not continue in the study if, a) your blood sugar

becomes very high or very low, b) you start on insulin or other medication that affect blood sugar,

c) you take part in any other trial.

What is the cost of the study?

All medication and tests to be done during the study will be free of charge.

If you do not want to participate, you are free to do so. It will not affect your medical

care or relationship with your doctor in any way.

What happens now if you decided to take part?

You will asked to sign a consent form saying that you have been given information about

the study and you voluntarily agree to take part.

It is important to follow all instruction given by your doctor or doctor’s assistant carefully.

DIET REGIMEN:

To take 25 cal/kg per day (Moderate work)

Protein 0.8 gm/kg per day

Total Fat < 30% of calories (Saturated fat < 10% polyunsaturated fat < 10% of calories)

Cholesterol < 300 mg per day

Dietary fibre 50 gm per day (atleast)

Common salt < 5 gm. per day


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Saturated fat & cholesterol are found in e.g. Ghee, Vanaspati, Dalda, Palm, Coconut oil.

These contain highly saturated fat. Patient should be advised to take less saturated fat and

cholesterol.

Poly unsaturated fat take Sun flower oil, Soyabene oil, Olive oil which contained

unsaturated fat should be taken 3 small tea spoonful / day.

Milk : Three cup daily double tone

Whole Cereal: 90 gm daily. [old samarice, kodo, java, wheat with husk]

Vegetable : 250 gm daily [padwal, karaila, methi, pumpkin, brinjal, beans]

Dal : 400 ml. daily [Moong, Masoor, Kulthi, Arhar, Garam]

Fruits : 200 gm. Daily [Apple,Guava & Pappaya]

Spices : [Ginger,coriander,cardamom]

DO’NT

To avoid smoking.

To avoid Fasting.

To avoid sweets, honey, sugar, jaggery, cold drinks, fruit juice, avoids fruits e.g. Mango,

Sharifa, Grapes, Chiku, Banana, Khajur, potato,turnip & beetroot

To be translated into regional language.


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MELLITUS

CASE REPORT FORM I - SCREENING

1. Centre: ______________________________

2. Name of the subject: ______________________________________________________

3. Sr. No. of the Subject : ____________________________________________________

4. Address : _______________________________________________________________

5. Date of Birth: Age (in yrs.) :

6. Code No. (of clinical trial)

7. Gender Male 1 Female 2

CRITERIA OF INCLUSION Yes (1) No (2)

1. Age between 30 years to 65 years


Blood sugar – Fasting > 26 and =< 200 mg/dl or

PP > 200 mg/dl and7% and


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Blood sugar – Fasting =< 126 and > than 200 or

PP=< 200 mg/dl >350 mg/dl or

Glycated haemoglobin10%

6. Malignant and accelerated hypertensive

7. CVS disorder (CAD)

8. Pregnant woman or the women planning to be pregnant

in next six months

9. Lactating mothers

10. Secondary Diabetes mellitus

11. Patient under going regular treatment for Diabetes or

for any other severe illness

12. CNS disorder e.g. encephalopathy

A patient is eligible for admission

If ‘Yes’ to S.No.1 – 3 & ‘No’ to 4 – 12

If admitted:

Sl. No. of the subject ____________

No. of packets issued____________

Date:____________ Signature of the Investigator _____________


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Chief complaint with duration (if any) in days

Absent (0) Present (1) Duration

13. Polyuria (Excessive Urine)

14. Polyphagia (Excessive Hunger)

15. Polydipsia (Excessive Thirst)

16. Exhaustion/Tiredness

17. Loss of body weight

18. Body ache

19. Giddiness

20. Polyneuritis(Numbness / Tingling)

21. Visual disturbance

22. Others

If Yes specify: _____________________________________

Personal History

23. Diet Veg. 1 Non-veg. 2 Lecto-veg 3

24. Presence of anxiety No 0 Yes 1

25. Constipation No 0 Yes 1

Addiction

26. Smoking No 0 Yes 1

If yes specify: (a) Quantity [packs]: ________________

(b) Total Duration in year’s ________________

27. Tobacco No 0 Yes 1

If yes specify: (a) Quantity: ________________

(b) Total Duration in years ________________


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28. Alcohol No 0 Yes 1

If yes specify: (a) Quantity (in ml/day): ________________

(b) Total Duration in years ________________

29. Any other(specify) _____________________

30. Prakriti: Vata 1 Pitta 2 Kapha 3

Vata-kaphaj 4 Vata-pittaja 5 Pitta-Kaphaja 6

Sannipataj 7

Physical Examination

31. Height (cm) ____________

32. Weight (kg) ____________

33. Pulse (per min) ____________

34. Blood Pressure (in sitting position)

Systolic_________________(mm Hg)

Diastolic ________________(mm Hg)

35. Body temperature (o F) _____________

36. Respiration rate (per min) _____________

37. Signs of dehydration and oedema, if any____________________

SYSTEMIC EXAMINATION Absent (0) Present (1)

38. CVS

If abnormal, details _______________________________________________________

39. CNS



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40. Digestive system


41. Uro-Genital system


42. Respiratory system


Date: ____________________ Signature of Investigator ___________________


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MELLITUS

CASE REPORT FORM III - CLINICAL & PHYSIOLOGICAL ASSESSMENT

[Before Treatment & Fortnightly During Treatment]

1. Centre: ______________________________


3. Sr. No. of the subject: ____________________________________________________

4. Name of the subject: ______________________________________________________

5. Address : _______________________________________________________________



8. Date of Assessment :

Chief complaint with duration (if any) in days

Absent (0) Present (1) Duration

(in days)

9. Polyuria (Excessive Urine)

10. Polyphagia (Excessive Hunger)

11. Polydipsia (Excessive Thirst)

12. Exhaustion/Tiredness

13. Bodyache

14. Giddiness

15. Polyneuritis (Numbness / Tingling)


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16. Visual disturbance

17. Others

If Yes, specify: ___________________________________________________________

Physiological Assessment

18. Weight (in Kgs.) ______________

19. Blood Pressure (in sitting position)

Systolic_________________ (mm Hg)

Diastolic ________________ (mm Hg)

Date: ______________ Signature of Investigator: _________________________


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MELLITUS

CASE REPORT FORM IV- LABORATORY INVESTIGATION

1. Centre: ______________________________


3. Sr. No. of the subject: _____________________________________________________

4. Name of the subject: _______________________________________________________

5. Address : _______________________________________________________________



8. Date of Assessment :

Urine Examination

Routine

9. Sugar ____________

10. Albumin ____________

11. Deposits ____________

Microscopic

12. Pus cell ____________(hpf)

13. RBC ____________(hpf)

14. Cast ____________(hpf)

Stool examination

15. Routine ____________


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Microscopic

16. Ova ____________

17. Cyst ____________

18. Occult Blood__________

Blood

19. TC (Cells/Cmm.): ____________

20. DC: P(%)_____ L(%)_____ E(%)_____ M(%)_____ B(%)_____

21. Hb (g/dl) ____________

22. (1st hour.) ____________

23. Blood Sugar- Fasting/PP (mg./dl)____________/____________

24. Glycosylated) HbA1c (to be done before treatment

after three months and end of treatment)

25. Blood Urea (mg. /dl) ____________

26. S.Creatinine (mg./dl) ____________

27. Uric acid (mg./dl) ____________

LIPID PROFILE

28. Serum total Cholesterol (mg./dl) ____________

29. S. Triglycerides (mg./dl) ____________

30. HDL (mg./dl) ____________

31. LDL (mg./dl) ____________

32. VLDL (mg/dl) ____________

LIVER FUNCTION TEST

Serum Bilirubin

33. Total (mg/dl) ____________


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34. Direct (mg/dl) ____________

35. SGOT (IU/L) ____________

36. SGPT (IU/L) ____________

37. Alk.Phosphatase (KA units) ____________

38. Total proteins (gm./dl) ____________

39. Albumin (gm./dl) ____________

40. Globulin (gm./dl) ____________

41. A/G Ratio ____________

Serum Electrolytes

42. Sodium(mEq/L) ____________

43. Potasium(mEq/L) ____________

Sl.No.9 – 43 will be done before and after treatment except Sl.No. 23 (Blood Sugar) which

will be done before treatment and fortnightly during treatment period. HbA1c will be repeated

after three months also.

Date: ______________ Signature of Investigator__________________________


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Clinical Research Protocols for Traditional Health Sciences.475-496

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