Protocol & Case Report Forms (CRF)

COMPARATIVE EFFECTIVENESS OF ‘NISAKATHAKADI KASHAYAM AND
KATHAKAKHADIRADI KASHAYAM’ IN TYPE 2 DIABETES MELLITUS

USING BIOCHEMICAL AND HRQOL PARAMETERS – A PROSPECTIVE
OBSERVATIONAL MULTICENTRIC STUDY
PROTOCOL & CASE REPORT FORMS (CRF)
1
KERALA UNIVERSITY OF HEALTH SCIENCES (KUHS)
Title of Study: COMPARATIVE EFFECTIVENESS OF ‘NISAKATHAKADI KASHAYAM AND

KATHAKAKHADIRADI KASHAYAM’ IN TYPE 2 DIABETES MELLITUS USING
BIOCHEMICAL AND HRQOL PARAMETERS – A PROSPECTIVE
OBSERVATIONAL MULTICENTRIC STUDY
Broad Subject : Health Science
Sub Area : Diabetes mellitus
Duration in months : 24 months
Total estimated cost : 10,06,750 rupees
Funding & Administration : Kerala University of Health Science (KUHS), Thrissur
Study Category : Applied Research
Principal Investigator : Dr.V.N.Radhakrishnan

Designation : Professor & HOD
Department : Kayachikitsa
Institute Name : Govt Ayurveda Medical College, TVPM
Address : M.G.Road
Telephone : 9447554165
Email : [email protected]
Co-Investigator : Dr.P.V Giri
Designation : Professor
Institute Name : Vaidyaratnam Ayurveda College

Address : Ollur
Co-Investigator : Dr Prakash Mangalasseri

2
Designation : Associate Professor
Institute Name : V.P.S.V Ayurveda College
Address : Malappuram
Co-Investigator : Dr.Sreelatha Chandroth
Designation : Associate Professor
Institute Name : Govt Ayurveda College, Kannur

Address : Pariyaram
Co-Investigator : Dr.Sunil John Thykkattil
Designation : Assistant Professor
Institute Name : Govt Ayurveda College, Trippunithura

Address : Ernakulam
Co-Investigator : Dr.Pravith N K
Designation : Assistant Professor
Institute Name : Govt Ayurveda College, Thiruvananthapuram

Address : M.G Road
Introduction:
3
A) Background and rationale:
Diabetes mellitus (DM) is a metabolic disorder resulting from a defect in insulin

secretion, insulin action, or both in turn leads to chronic hyperglycaemia with disturbances
of carbohydrate, fat and protein metabolism. DM is the most common endocrine disorder
and according to International Diabetes Federation it was estimated that, in 2013, 382
million people (a prevalence of 8.3%) and by 2035, 592 million people worldwide will suffer
from it. India leads the world behind China with largest number of diabetic subjects
earning the dubious distinction of being termed the “Diabetes capital of the world”. The I
D F estimates the total number of diabetic subjects is set to rise to 69.9 million by the year
2025 in India.1,2 A very high prevalence of 16.3 per cent was reported in
Thiruvananthapuram in Kerala State in the year 1999. 3 A community based cross-sectional
survey done in urban areas of Ernakulam district in Kerala has revealed a very high
prevalence of 19.5 percentage.4 This phenomenal rise in diabetes has been ascribed to
rapid changes in demographic, nutritional and socioeconomic factors, the so-called
epidemiologic, nutritional and economic transition. Type 2 diabetes is the commonest form
of diabetes and is characterized by disorders of insulin secretion and insulin resistance.
Modern Pharmacological interventions in Type 2 diabetes are aimed primarily to save life
and alleviate symptoms. Secondary aims are to prevent long-term diabetic complications
and, by eliminating various risk factors, to increase longevity.
B) Scope:
Modern system of medicine manages Diabetes Mellitus with insulin and oral
hypoglycaemic drugs. Clinical trial and research work shows, herbal remedies for Diabetes
as effective, safe and helpful in slowing down complications. Ayurveda formulations are cost
effective and will be a safe solution for the millions of sufferers.
Ayurvedic herbs namely Gymnema sylvestere, Momordica charantia, Trigonella

foenumgraecum, Coccinia indica, Pterocarpus marsupium and Ficus bengalensis are
extensively researched for their hypoglycemic effect as a single drug by animal experiments
and clinical studies by various scholars. Certain polyherbal / herbomineral combinations like
Ayush-82, MA-471, Abraga Chendooram, D-400, Sandan Podia, and M-93 are also proved
for hypoglycemic effect. 5
The two study drugs Nisakathakadi kashaya and kathakakhadiradi kashaya are
widely prescribed by Ayurvedic physicians in reducing blood sugar level, though yet not
documented popularly. Also concept of Tridoshas (Vata, Pitha & Kapha) are considered to
be the backbone of Ayurveda. According to Ayurvedic treatise, treatment varies according
to doshic subtypes. So the present study is aimed at evaluating and comparing the
effectiveness of these drugs as well as to find out in which dosha predominance they are
more suitable.
Defining the problems
4
 Assessing and comparing the hypoglycemic effect of Nisakathakadi Kashaya and
Kathakakhadiradi Kashaya in Type II DM.
 Improving the quality of life in patients of Type II DM.
Relevance & Importance for the study

Ayurvedic Herbal preparations are easy to follow, and was traditionally accustomed and
safe to our people. Diabetes like non communicable diseases was controlled well in olden days
through Ayurveda. There is an increased demand regarding awareness of classical Ayurvedic
treatment among diabetic patients worldwide. The selected drugs are cost effective and satisfy
the alternative approach in Diabetes. Ayurvedic medicine may further improve quality of life in
patients of Type II DM.
Goals
 To identify the role of Ayurveda as a supportive measure in non communicable diseases

like Type II DM in a global perspective.
 To validate the classical Dosha based management .
 To create awareness among scientific world regarding classical Ayurvedic therapy thus
by reviving our traditional practices.
OBJECTIVES
 To evaluate the hypoglycemic effect of Nisakathakadi Kashaya in Type 2 DM.

 To evaluate the hypoglycemic effect of Kathakakhadiradi Kashaya in Type 2 DM.
 To compare the effectiveness of Nisakathakadi and kathakakhadiradi kashaya in type 2
DM.
 To study the role of Nisakathakadi Kashaya and Kathakakhadiradi Kashaya in improving
the Quality of Life in patients of Type2 DM.
 To assess the dosha predominance in which Nisakathakadi and Kathakakhadiradi is
more effective.
Plan of study
Study design - Observational design

5
Setting: OPD’s of :-
1. Govt. Ayurveda College, Thiruvananthapuram, Kerala.
2. Govt. Ayurveda College,, Trippunithura, Ernakulam, Kerala.
3. Govt. Ayurveda College, Kannur, Kerala.
4. Vaidyaratnam Ayurveda College, Ollur, Thrissur, , Kerala and
5. V.P.S.V Ayurveda College, Kottakkal, Malappuram, Kerala.
Duration of Study : 24 months
Observation Period : 120 days
Group allocation:-
Group I – Type 2 DM patients those who will be given Nisakathakadi kashayam.
Group II – Type 2 DM patients those who will be given Kathakakhadiradi kashayam.
Materials & methods
A total of Three hundred patients( thirty patients in each group from each
hospital) satisfying the eligibility criteria will be selected from the OPD of Ayurveda
College Hospitals at Thiruvananthapuram, Trippunithura, Kannur, Ollur and Kottakkal.
Administration of Study drugs will be as follows:
Drug Intervention
In Group I - Nisakathakadi Kashaya
In Group II - Kathakakhadiradi Kashaya
Dose of Kashaya : 60ml( 15ml prepared kashaya + 45ml luke warm water) in
both groups.
Time : One hour prior to Breakfast and Dinner
Duration : 120 days
CRITERIA FOR INCLUSION (Group I & II)
1. Age between 30 years to 60 years
2. Satisfying any of the three:-

6
Blood sugar – Fasting > 120 and =< 180 mg/dl or
PPBS > 160 mg/dl and<= 240 mg/dl or
Glycated haemoglobin>7% and <9 %
CRITERIA FOR EXCLUSION(Group I & II)
1. Those who are under Insulin therapy.
2. Established case of IHD/Stroke
3. Pregnant woman or the women planning to be pregnant in next six months
4. Lactating mother
5. Psychiatric patient
6. Patient with Serum creatinine ≥ 1.5mg/dl
7. Patient with diabetic foot/ Nephropathy
CRITERIA FOR WITHDRAWAL

The investigator shall withdraw the patients from the study if
 Fasting blood sugar rises to >180 mg. /dl. or post prandial blood sugar level increases to
>240 mg./dl and are not controllable within 30 days.
 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.
SAMPLING
a) Sample Size – Total sample size is 300. 60 samples in each five centres with 30 in
group I and 30 in group II.
b) Method of selection – Diabetic patients attending the setting is primarily screened for
satisfying Inclusion and Exclusion criteria. From those, who are ready to give informed
consent, participants will be allocated for each group consecutively till sample size is
achieved.
STUDY VARIABLES
1. Fasting plasma glucose with no caloric intake for at least 8 hour
2. Two hour postprandial plasma glucose
7
3. Hb A1c
4. Scale to assess of Quality of life in DM which is authentic and suitable to the population.
DEFINING AND METHOD OF ESTIMATING THEM
1. Laboratory investigations
2. Questionnaire method
3. Personnel interview
RESEARCH TOOLS
1. Case record form
2. Questionnaire for assessment of Health Related Quality of life (HRQOL)
METHODS OF DATA COLLECTION
1. Personnel interview with Case record form / Questionnaires
2. Biochemical evaluations will be carried out in clinical laboratory.
STATISTICAL ANALYSIS
The data collected will be entered into MS Excel Master sheet. Questionnaire
and HRQOL will be assessed by Chi Square test. t – test and ANOVA will be used to test the
efficacy of study drugs using ‘R’ software.
Resources available
 Patients attending the OPD of Govt. Ayurveda Colleges at Thiruvananthapuram,

Thrippunithura & Kannur, Vaidyaratnam Ayurveda College - Ollur and VPSV Ayurveda
College - Kottakkal.
 Clinical Laboratories at each college. [HbA1c test will be outsourced to a laboratory with
NABL accreditation, having branches available near each centre.]
 Nisakathakadi and Kathakakhadiradi Kashaya will be collected from a GMP certified
pharmacy.
Flow chart representation of the study design
Primary screening of Patients using Case report form - I
8
Consecutively allotted into group I and II
Primary assessment using Case report form-II, III and QOLID
Nisakathakadi Kashaya (n=30) Kathakakhadiradi Kashaya (n=30)

Drug Intervention
Group I (120 days) Group II (120 days)
IInd assessment (31st day) using Case report form- III
IIIrd assessment 61th day) using Case report form- III
IVth assessment (91th day) using Case report form- III
Vth assessment (121st day) using Case report form- III and QOLID
Final Assessment, Data Compilation and analysis,

preparation of final report and submission
Budget with justification –

1. BLOOD & URINE INVESTIGATION:
9
Sl.No Investigation Cost No. of tests needed for Total Expenditure
one participant
1 Blood Routine 35 2 70
2 F.B.S & P.P.B.S 30 5 150
3 Hb A1c 400 2 800
4 Total Cholesterol 40 2 80
5 Total Bilirubin 30 2 60
7 S.Creatinine 20 3 60
8 Urine Routine 20 3 60
Total 575 1280
Total For 300 participants = 1280 X 300 = 3,84,000/-
Drop outs @20% (of sample size ) = 60 X 575 = 34,500/-
Grand total for investigations =Rs. 4,01,250/-
2. STATIONERY, PRINTING AND XEROX(FOR ONE INSTITUTION)
Sl.No Items Specifications Expenditure in Rupees
1 Paper 2 bundles(500 each) 600
2 Xerox of Case Report Forms 30 pages X 60 1800
3 File boards 10 X 60 600
4 Stapler, Clips etc 500
5 Miscellaneous 5000
Total for one Institution = Rs. 8500/-
Total for 5 institutions = 8500 X 5 = Rs.42500/-
3. COST OF MEDICINES:
Sl.No Items Rate per No.of bottles Cost of Cost of

200ml needed for medicine medicine
10
bottle (in one for one for 150
rupees) participant participant participants
1 Nisakathakadi kashayam 105 18 1890 2,83,500
2 Kathakakhadiradi 85 18 1530 2,29,500

kashayam
Total 3420 5,13,000
Drop outs (@20%) ≈ Rs. 25,000/-
Total Expenditure for Medicines = Rs. 5,38,000/-
4. Remuneration for Statistician = Rs.25000/-
Total Amount = Rs.10,06,750/-
ETHICAL CONSIDERATION:
A. The drugs used in this study are mentioned in the classical text books of Ayurveda and
are having no known side effects in long term use. These two medicines are widely used
among Government and private Ayurvedic Hospitals in Kerala.
B. 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
the patient at the time of entry to the trial.
References:
11
1. Leonor Guariguata, Tim Nolan, Jessica Beagley, Ute Linnenkamp, Olivier Jacqmain.
(Editors.), IDF Diabetes Atlas 6th Ed, International Diabetes Federation Annual Report 2013,
The Global Burden, Chapter 2, Page 33.
2. Ibid, Regional Overviews, Chapter 3, South East Asia, Page 66
3. Raman Kutty V, Joseph A, Soman CR. High prevalence of type 2 diabetes in an urban
settlement in Kerala, India. Ethn Health 1999; 4 : 231-9.
4. Menon VU, Kumar KV, Gilchrist A, Sugathan TN, Sundaram KR, Nair V, et al. Prevalence
of known and undetected diabetes and associated risk factors in central Kerala - ADEPS.
Diabetes Res Clin Pract 2006; 74 : 289-94.
5. Lakshmi Chandra Mishra et al(2004), Scientific Basis for Ayurvedic Therapies, CRC Press,
Boca Raton London New York Washington, D.C. page no.108-121
12
COMPARATIVE EFFECTIVENESS OF ‘NISAKATHAKADI KASHAYAM AND KATHAKAKHADIRADI
KASHAYAM’ IN TYPE 2 DIABETES MELLITUS USING BIOCHEMICAL AND HRQOL PARAMETERS –
A PROSPECTIVE OBSERVATIONAL MULTICENTRIC STUDY
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_________________
Name____________________
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 Clinical Evaluation of Ayurveda formulations on the glycemic level of Type
II Diabetes Mellitus.
Date:___________ Name of the Subject:______________________
Signature or Thumb impression_____________
Date:____________ Name of witness:________________________
Signature or Thumb impression:____________
Relationship ____________
(Will be translated to regional language)
13
KASHAYAM’ IN TYPE 2 DIABETES MELLITUS USING BIOCHEMICAL AND HRQOL PARAMETERS –
A PROSPECTIVE OBSERVATIONAL MULTICENTRIC STUDY
PATIENT INFORMATION SHEET

What is the study about? - Research is going on to find the effect of Ayurvedic formulations in
reducing the sugar level as well as improving the quality of life in Diabetic patients. You are
invited to participate in such a study in which you will receive Ayurvedic trial drugs .
Total 60 patients from this hospital and 240 patients from other hospitals will be taking
part in this study.
What will you have to do? -Your doctor will explain clearly what you have to do. It is
important that you follow the instructions scrupulously. The study will take approximately four
months to complete. During this period, you are expected to visit the hospital every fortnight.
The interval between the first and second visit will be around 15 days. Before you start
treatment, during the first visit to the clinic, you will undergo a complete physical examination.
Blood and urine samples will also be taken. This is to make sure that you are eligible for the
study.
One week later, at your second visit, if you are eligible, you would be put on trial
treatment for 120 days. You may receive trial drug for 120 days and will be advised to collect
them every 2 weeks. You should follow life style modifications (Diets Advice & Exercise) as
given along with information Sheet.
At the end of every 30 days, you will be required to fast overnight before attending the
O.P. and Blood and urine samples will be taken. At each visit, you will be supplied with sufficient
quantity of drug to last until your next visit. After 120 days the trial drug will be stopped.
What happens at the end of the study? - After the study you will be put back on an
appropriate treatment available in the market.
Are there any risks? - Trial drug 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 or glucose/biscuits
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.
14
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:
1000 cal 1500 cal 2000 cal
Breakfast Dosha /Iddly Dosha /Iddly Dosha /Iddly

/Appam With 2 /Appam With 3 /Appam With 4
sambar / pieces sambar / stew / pieces sambar / stew pieces
stew/green gram green gram /green gram
Lunch Rice cooked 1 cup Rice cooked 1 ½ cup Rice cooked 2 cup
Vegetable curry ½ cup Vegetable curry 1 cup Vegetable curry 1 cup
Thoran / Aviyal 1 cup Thoran / Aviyal 1 ½ cup Thoran / Aviyal 2 cup
Fish for Nonveg 1p Fish for Nonveg 1p Fish for Nonveg 2p
Green salad 1 plate Green salad 1 plate Green salad 1 plate
Afternoo Sugarless Tea 1 cup Sugarless Tea 1 cup Sugarless Tea 1 cup
n
Dinner Chappathi /Wheat 2 Chappathi /Wheat 2½ Chappathi 3
dosha pieces dosha pieces /Wheat dosha pieces
Vendeka/peas Vendeka/peas Vendeka/peas 1½
½ cup 1 cup
masala masala masala cup
Salad ¼ cup Salad ½ cup Salad 1 cup
Fruit 1 Fruit 1 Fruit 1
Fruit preferably an Apple or Guava
DO’NTs - To avoid smoking. To avoid Fasting. To avoid sweets, honey, sugar, Jiggery, cold drinks, fruit
juice, Potato, Tapioca& Beetroot. Avoid more sweet fruits like Mango, Grapes, Chiku, Banana, Dates etc.
Exercise – 45 minutes brisk walk daily evening.
15
KASHAYAM’ IN TYPE II DIABETES MELLITUS USING BIOCHEMICAL AND HRQOL PARAMETERS – A
PROSPECTIVE OBSERVATIONAL MULTICENTRIC STUDY
CASE REPORT FORM I – SCREENING
1. Code No. (of clinical trial)
2. Centre: _____________
3. Name of the subject: ____________________________________
4. S.No. of the subject: ____________________________________
5. Gender Male (1) Female (2)
6. Date of Birth: Age (in yrs.)
7. Address: ______________________________________________________
CRITERIA FOR INCLUSION Yes No
8. Age between 30 years to 60 years
9. Satisfying any of the three
Blood sugar – Fasting > 120 and =< 180 mg/dl or
PPBS > 160 mg/dl and<= 240 mg/dl or
Glycated haemoglobin>7% and <9 %
CRITERIA FOR EXCLUSION

16
10. Those who are under Insulin/Hypoglycemic agents.
11. Established case of IHD/Stroke.
12. Pregnant woman or the women planning to be
pregnant in next six months
13. Lactating mother
14. Psychiatric patient
15. Patient with Serum creatinine ≥ 1.5mg/dl
16. Patient with diabetic foot/ Nephropathy
If answers for Q.No. 8 and 9 are ‘Yes’ and 10 to 18 are ‘No’ then the participant is eligible for
the study.
Date:____________ Signature of the Investigator _____________
17
KASHAYAM’ IN TYPE 2 DIABETES MELLITUS USING BIOCHEMICAL AND HRQOL PARAMETERS – A
CASE REPORT FORM II – HISTORY
2. Centre: _____________
3. Name of the subject: ___________________________________
4. S.No. of the subject: ___________________________________
5. Gender Male (1) Female (2)
6. Date of Birth: Age (in yrs.)
7. Address: ___________________________________________________________
___________________________________________________________
8. Place: Urban Rural

9. Socio economic Status (Kuppuswamy’s socio economic status scale):
A. Education score:
Profession/ Honours 7 Graduate or Post Graduate

6 Intermediate/Post High school Diploma 5 High
School Certificate 4
Middle School certificate 3 Primary School certificate 2 Illiterate

1
B. Occupation Score:
Profession 10 Semi-Profession 6 Clerical/Shop
keeper/Farmer 5 Skilled work 4 Semi Skilled worker 3 Unskilled
worker 2 Unemployed 1
C. Monthly Family Income(in Indian Rupees):
32050 or above 12 16020 – 32049 10 12020 –
16019 6
18
8010 – 12019 4 4810 – 8009 3 1601 – 4809 2
1600 or less 1
Total Score: Socio Economic Class
10. Religion: Hindu Muslim Sikh
Christian Parsi
11. Whether under any Oral Hypoglycemic agents? Yes No
If Yes, specify ____________________________________
12. Prakrithi of the person
Vata Pitta Kapha
Vata-Kaphaja Vata-Pittaja Pittaja-Kaphaja
Sannipataja
Chief complaint with duration (if any) in days
Present (1) Absent (0) Duration (in days)
13. Polyuria( Excessive Urine)
14. Polyphagia( Excessive Hunger)
15. Polydipsia( Excessive Thirst)
16. Exhaustion/Tiredness
19
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: Vegetarian Non-veg Pesco-veg
24. Presence of anxiety No Yes
25. Constipation No Yes
Addiction
26. Smoking No Yes
If yes specify: (a) Quantity [packs]: _________ (b) Total Duration in year’s_________
27. Tobacco No Yes
If yes specify: (a) Quantity: ___________ (b) Total Duration in years_________
28. Alcohol No Yes

If yes specify: (a) Quantity (in ml/day):_________ (b) Total Duration in years_________
29. Any other(specify)_____________________
20
Physical Examination
30. Height (cm) ____________
31. Weight (kg) ____________
32. Pulse (per min) ____________
33. Blood Pressure (in sitting position)
Systolic_________________(mm Hg)
Diastolic ________________(mm Hg)
34. Body temperature( o Fh) _____________
35. Respiration rate ( per min) _____________
36. Signs of dehydration and oedema, if any____________________
Systemic examination Absent (0) Present (1)
37. CVS
If abnormal, details _______________________________________________
_______________________________________________
38. CNS
If abnormal, details ______________________________________________
______________________________________________
39. Digestive system

______________________________________________
40. Uro-Genital system

______________________________________________
41. Respiratory system

21
______________________________________________
Date: ______________________ Signature of Investigator _______________________

KASHAYAM’ IN TYPE 2 DIABETES MELLITUS USING BIOCHEMICAL AND HRQOL PARAMETERS – A
CASE REPORT FORM III - CLINICAL & PHYSIOLOGICAL ASSESSMENT
2. Centre: _____________
3. Name of the subject: ____________________________________
4. S.No. of the subject:
A. Diabetes Symptom Assessment

[The first box 󲐀0 is for ‘None of the time’. Box 󲐀 1 is for ‘A little of the time’. Box 󲐀 2 is for ‘Some of
the time’.Box 󲐀 3 is for ‘Most of the time’ and box 󲐀 4 is for ‘All of the time’. Over the last one month
if the study participant (patient) experience any of the following, mark the appropriate boxes:]
Ayurvedic Dosha parameter is given along with each symptom.
22
Before 31st day 61st day 91stday 120st day
Treatment
1. Cold hands 󲐀0 󲐀0 󲐀0 󲐀0 󲐀0
and/or feet 󲐀1 󲐀1 󲐀1 󲐀1 󲐀1
(Kapha) 󲐀2 󲐀2 󲐀2 󲐀2 󲐀2
󲐀3 󲐀3 󲐀3 󲐀3 󲐀3
󲐀4 󲐀4 󲐀4 󲐀4 󲐀4
2. An overall sense 󲐀0 󲐀0 󲐀0 󲐀0 󲐀0
of fatigue 󲐀1 󲐀1 󲐀1 󲐀1 󲐀1
(Kapha) 󲐀2 󲐀2 󲐀2 󲐀2 󲐀2
󲐀3 󲐀3 󲐀3 󲐀3 󲐀3
󲐀4 󲐀4 󲐀4 󲐀4 󲐀4
3.Burning 󲐀0 󲐀0 󲐀0 󲐀0 󲐀0
sensation on 󲐀1 󲐀1 󲐀1 󲐀1 󲐀1
hands/feet 󲐀2 󲐀2 󲐀2 󲐀2 󲐀2
(Pitha) 󲐀3 󲐀3 󲐀3 󲐀3 󲐀3
󲐀4 󲐀4 󲐀4 󲐀4 󲐀4
4. Sleepiness or 󲐀0 󲐀0 󲐀0 󲐀0 󲐀0
drowsiness (during 󲐀1 󲐀1 󲐀1 󲐀1 󲐀1
the day) 󲐀2 󲐀2 󲐀2 󲐀2 󲐀2
(Kapha) 󲐀3 󲐀3 󲐀3 󲐀3 󲐀3
󲐀4 󲐀4 󲐀4 󲐀4 󲐀4
󲐀0 󲐀0 󲐀0 󲐀0 󲐀0
5. Blurred vision 󲐀1 󲐀1 󲐀1 󲐀1 󲐀1
(also with glasses 󲐀2 󲐀2 󲐀2 󲐀2 󲐀2
on) (Pitha) 󲐀3 󲐀3 󲐀3 󲐀3 󲐀3
󲐀4 󲐀4 󲐀4 󲐀4 󲐀4
6. Dry mouth 󲐀0 󲐀0 󲐀0 󲐀0 󲐀0
(Vata) 󲐀1 󲐀1 󲐀1 󲐀1 󲐀1
󲐀2 󲐀2 󲐀2 󲐀2 󲐀2
󲐀3 󲐀3 󲐀3 󲐀3 󲐀3
󲐀4 󲐀4 󲐀4 󲐀4 󲐀4
7. Felt unusually 󲐀0 󲐀0 󲐀0 󲐀0 󲐀0
thirsty 󲐀1 󲐀1 󲐀1 󲐀1 󲐀1
(Pitha) 󲐀2 󲐀2 󲐀2 󲐀2 󲐀2
󲐀3 󲐀3 󲐀3 󲐀3 󲐀3
󲐀4 󲐀4 󲐀4 󲐀4 󲐀4
23
8. Felt unusually 󲐀0 󲐀0 󲐀0 󲐀0 󲐀0
hungry 󲐀1 󲐀1 󲐀1 󲐀1 󲐀1
(Pitha) 󲐀2 󲐀2 󲐀2 󲐀2 󲐀2
󲐀3 󲐀3 󲐀3 󲐀3 󲐀3
󲐀4 󲐀4 󲐀4 󲐀4 󲐀4
9. Frequent need 󲐀0 󲐀0 󲐀0 󲐀0 󲐀0
to urinate (Vata) 󲐀1 󲐀1 󲐀1 󲐀1 󲐀1
󲐀2 󲐀2 󲐀2 󲐀2 󲐀2
󲐀3 󲐀3 󲐀3 󲐀3 󲐀3
󲐀4 󲐀4 󲐀4 󲐀4 󲐀4
10. Tingling or 󲐀0 󲐀0 󲐀0 󲐀0 󲐀0
prickling 󲐀1 󲐀1 󲐀1 󲐀1 󲐀1
sensations in 󲐀2 󲐀2 󲐀2 󲐀2 󲐀2
hands or feet 󲐀3 󲐀3 󲐀3 󲐀3 󲐀3
(Vata) 󲐀4 󲐀4 󲐀4 󲐀4 󲐀4
11. Cramping in 󲐀0 󲐀0 󲐀0 󲐀0 󲐀0
legs or feet 󲐀1 󲐀1 󲐀1 󲐀1 󲐀1
(Vata) 󲐀2 󲐀2 󲐀2 󲐀2 󲐀2
󲐀3 󲐀3 󲐀3 󲐀3 󲐀3
󲐀4 󲐀4 󲐀4 󲐀4 󲐀4
󲐀0 󲐀0 󲐀0 󲐀0 󲐀0
12. Irritability
󲐀1 󲐀1 󲐀1 󲐀1 󲐀1
(Vata)
󲐀2 󲐀2 󲐀2 󲐀2 󲐀2
󲐀3 󲐀3 󲐀3 󲐀3 󲐀3
󲐀4 󲐀4 󲐀4 󲐀4 󲐀4
13. Felt you were 󲐀0 󲐀0 󲐀0 󲐀0 󲐀0

not thinking as 󲐀1 󲐀1 󲐀1 󲐀1 󲐀1
quickly as you can 󲐀2 󲐀2 󲐀2 󲐀2 󲐀2
(Kapha) 󲐀3 󲐀3 󲐀3 󲐀3 󲐀3
󲐀4 󲐀4 󲐀4 󲐀4 󲐀4
14. Broke out into 󲐀0 󲐀0 󲐀0 󲐀0 󲐀0

a sweat(not 󲐀1 󲐀1 󲐀1 󲐀1 󲐀1
because of 󲐀2 󲐀2 󲐀2 󲐀2 󲐀2
exercise/physical 󲐀3 󲐀3 󲐀3 󲐀3 󲐀3
exertion) 󲐀4 󲐀4 󲐀4 󲐀4 󲐀4
(Pitha)
15. Felt faint, dizzy 󲐀0 󲐀0 󲐀0 󲐀0 󲐀0
24
or light headed. 󲐀1 󲐀1 󲐀1 󲐀1 󲐀1
(Vata) 󲐀2 󲐀2 󲐀2 󲐀2 󲐀2
󲐀3 󲐀3 󲐀3 󲐀3 󲐀3
󲐀4 󲐀4 󲐀4 󲐀4 󲐀4
16. Upset
stomach/nausea 󲐀0 󲐀0 󲐀0 󲐀0 󲐀0
(Kapha) 󲐀1 󲐀1 󲐀1 󲐀1 󲐀1
󲐀2 󲐀2 󲐀2 󲐀2 󲐀2
󲐀3 󲐀3 󲐀3 󲐀3 󲐀3
󲐀4 󲐀4 󲐀4 󲐀4 󲐀4
17. Heart burn
󲐀0 󲐀0 󲐀0 󲐀0 󲐀0
(Pitha)
󲐀1 󲐀1 󲐀1 󲐀1 󲐀1
󲐀2 󲐀2 󲐀2 󲐀2 󲐀2
󲐀3 󲐀3 󲐀3 󲐀3 󲐀3
󲐀4 󲐀4 󲐀4 󲐀4 󲐀4
18. Weight gain 󲐀0 󲐀0 󲐀0 󲐀0 󲐀0

(Kapha) 󲐀1 󲐀1 󲐀1 󲐀1 󲐀1
󲐀2 󲐀2 󲐀2 󲐀2 󲐀2
󲐀3 󲐀3 󲐀3 󲐀3 󲐀3
󲐀4 󲐀4 󲐀4 󲐀4 󲐀4
Total Score
Symptom Assessment ( Ayurveda)
Total Score
Vata Pitha Kapha
B. Laboratory investigations
Blood:-
Before 31th day 61nth day 91th day 121nth day

treatment
Haemoglobin (gm/dl)
Total count
(Cells/Cmm)
Polymorphs(%)
Lymphocytes
25
Eosinophills
Monocytes
Lymphocytes
ESR (at the end of I

hr)
HbA1c
Total Cholesterol
(mg/dl)
Total Bilirubin(mg/dl)
S.Creatinine(mg/dl)
F.B.S(mg/dl)
P.P.B.S(mg/dl)
Urine:-
Before 31st day 61th day 91th day 120th day

treatment
Sugar
Albumin
Deposits
Pus cells (hpf)
RBC(hpf)
Cast(hpf)
C. Physiological Assessment:
Before 31th day 61th day 91th day 120th day

treatment
Blood Pressure
(sitting) mm/Hg
26
Weight in Kgs
B.M.I
Date: ______________________ Signature of Investigator _______________________
Quality of Life Instrument for Indian Diabetes Patients

(QOLID) © JAPI • may 2010 • VOL. 58 295
Primary Assessment – Before treatment(Day 0)
Role Limitation Due to Physical Health
1. How often do you miss your work because of your diabetes?
Always Frequently Often Sometimes Never
1 2 3 4 5
2. A person with diabetes has the requirement of adhering to a schedule for eating and taking
regular medication. How often does this affect your work?
1 2 3 4 5
3. How often does diabetes affect your efficiency at work?
1 2 3 4 5
4. How often do you find diabetes limiting your social life?
1 2 3 4 5
5. To what extent do you avoid traveling (business tour, holiday,general outings) because of
your diabetes?
A lot Highly Little Very little Not at all
1 2 3 4 5
27
6. Compared to others of your age are your social activities (visiting friends/partying) limited
because of your diabetes?
1 2 3 4 5
Physical Endurance
An important part of understanding your general health and well being has to do with your
ability to perform various activities.Thus for the following questions please indicate if your
health has limited your activities in following areas in the past three months. Please tick any
one option.
1. How often in last three months has your overall health problems limited the kind of vigorous
activities you can do like lifting heavy bags/objects, running, skipping, jumping.
1 2 3 4 5
2. How often in last three months has your overall health problems limited the kind of
moderate activities you can do like moving a table, carrying groceries or utensils.
1 2 3 4 5
3. How often in last three months has your overall health problems limited you from walking
uphill or climbing 1-2 floors.
1 2 3 4 5
4. How often in last three months has your overall health problems limited you from walking 1-
2 km at a stretch.
1 2 3 4 5
5. How often in last three months has your overall health problems limited you from bending,
squatting, or turning.
1 2 3 4 5
6. How often in last three months has your overall health problems limited you from eating,
dressing, bathing, or using the toilet.
1 2 3 4 5
General Health
1. In general would you say your health is.
Poor Fair Good Very good Excellent
1 2 3 4 5
28
2. How well are you able to concentrate in everything like working, driving, reading etc?
Not at all A little Moderate Very much An extreme amount
1 2 3 4 5
3. How many times in the past three months have you had fatigue/ felt very tired?
1 2 3 4 5
Treatment Satisfaction
The following set of questions would enable us to know how satisfied are you with your
treatment for diabetes. Please tick any one option.
1. How satisfied are you with your current diabetes treatment?
Very Moderately Neither Moderately Very
dissatisfied dissatisfied satisfied nor dissatisfied Satisfied satisfied
1 2 3 4 5
2. How satisfied are you with amount of time it takes to manage your diabetes?
1 2 3 4 5
3. How satisfied are you with the amount of time you spend getting regular checkups (once in 3
months)?
1 2 3 4 5
4. A person with diabetes needs to exercise for 35-45 min, 4 times a week. Keeping this in mind
how satisfied are you with the time you spend exercising?
1 2 3 4 5
Symptom Botherness
1. How many times in the past three months have you had thirst/dry mouth?
29
1 2 3 4 5
2. How many times in the past three months have you felt excessive hunger?
1 2 3 4 5
3. How many times in the past three months have you had frequent urination related to
diabetes management?
1 2 3 4 5
Financial Worries
The following set of questions will help us know how your diabetes has affected your or your
family’s finances. Please tick any one option….
1. What do you think about the cost involved in your management of diabetes?
Very expensive little expensive reasonable not at all Expensive
1 2 3 4 5
2. To what extent has your priority of expenditure shifted towards diabetes management?
1 2 3 4 5
3. To what extent has your family budget got affected by the expenses related to the
management of diabetes?
1 2 3 4 5
4. To what extent has your diabetes limited your expenditure on other aspects of life (Movies,
outings, parties etc)?
1 2 3 4 5
Emotional/Mental Health
1. How satisfied are you with yourself?
Very Moderately Neither Moderatel Very
y
dissatisfied dissatisfied satisfied nor dissatisfied satisfied
Satisfied
1 2 3 4 5
2. How satisfied are you with your personal relationship(family, friends,relatives and known tos)
30
y
Satisfied
1 2 3 4 5
3. How satisfied are you with the emotional support you get from your friends and family?
y
Satisfied
1 2 3 4 5
4. How often are you discouraged by your health problems?
1 2 3 4 5
5. All people want to fulfill certain roles and lead their lives in a purposeful manner. To what
extent do you feel that you have been able to lead your life in the same way?
1 2 3 4 5
Diet Satisfaction
Diabetes demands a little modification in diet, thus the following set of questions would help us
know how much satisfied you are with modifications in your diet.(For participants who have
been advised some dietary modification/counseling).
1. How often do you feel because of your diabetes a restriction in choosing your food when
eating out?
1 2 3 4 5
2. As you have diabetes, how much choice do you feel you have in eating your meals or snacks
away from home e.g. if you go in a party and there is a buffet where there are also a lot of fried
snacks and desserts would you be able to make enough choice?
No choice Very little little enough A lot
1 2 3 4 5
3. How often do you eat the food items that you shouldn’t, in order to hide the fact that you are
having diabetes.
1 2 3 4 5
QOLID Score:
SCALE NUMBER OF ITEMS AVERAGE OF THE ITEMS
Role Limitation Due to Physical 6
Health
31
Physical Endurance 6
General Health 3
Treatment Satisfaction 4
Symptom Botherness 3
Financial Worries 4
Emotional/Mental Health 5
Diet Satisfaction 3
Date _______________ Signature of Invigilator_________________________
Quality of Life Instrument for Indian Diabetes Patients

(QOLID) © JAPI • may 2010 • VOL. 58 295
After treatment Assessment –Day 85
Role Limitation Due to Physical Health
1. How often do you miss your work because of your diabetes?
1 2 3 4 5
2. A person with diabetes has the requirement of adhering to a schedule for eating and taking
regular medication. How often does this affect your work?
1 2 3 4 5
3. How often does diabetes affect your efficiency at work?
1 2 3 4 5
4. How often do you find diabetes limiting your social life?
1 2 3 4 5
5. To what extent do you avoid traveling (business tour, holiday,general outings) because of
your diabetes?
1 2 3 4 5
6. Compared to others of your age are your social activities (visiting friends/partying) limited
because of your diabetes?
32
1 2 3 4 5
Physical Endurance
An important part of understanding your general health and well being has to do with your
ability to perform various activities.Thus for the following questions please indicate if your
health has limited your activities in following areas in the past three months. Please tick any
one option.
1. How often in last three months has your overall health problems limited the kind of vigorous
activities you can do like lifting heavy bags/objects, running, skipping, jumping.
1 2 3 4 5
2. How often in last three months has your overall health problems limited the kind of
moderate activities you can do like moving a table, carrying groceries or utensils.
1 2 3 4 5
3. How often in last three months has your overall health problems limited you from walking
uphill or climbing 1-2 floors.
1 2 3 4 5
4. How often in last three months has your overall health problems limited you from walking 1-
2 km at a stretch.
1 2 3 4 5
5. How often in last three months has your overall health problems limited you from bending,
squatting, or turning.
1 2 3 4 5
6. How often in last three months has your overall health problems limited you from eating,
dressing, bathing, or using the toilet.
1 2 3 4 5
General Health
1. In general would you say your health is.
Poor Fair Good Very good Excellent
1 2 3 4 5
33
2. How well are you able to concentrate in everything like working, driving, reading etc?
1 2 3 4 5
3. How many times in the past three months have you had fatigue/ felt very tired?
1 2 3 4 5
Treatment Satisfaction
The following set of questions would enable us to know how satisfied are you with your
treatment for diabetes. Please tick any one option.
1. How satisfied are you with your current diabetes treatment?
1 2 3 4 5
2. How satisfied are you with amount of time it takes to manage your diabetes?
1 2 3 4 5
3. How satisfied are you with the amount of time you spend getting regular checkups (once in 3
months)?
1 2 3 4 5
4. A person with diabetes needs to exercise for 35-45 min, 4 times a week. Keeping this in mind
how satisfied are you with the time you spend exercising?
Dissatisfied dissatisfied satisfied nor dissatisfied Satisfied satisfied
1 2 3 4 5
Symptom Botherness
1. How many times in the past three months have you had thirst/dry mouth?
34
1 2 3 4 5
2. How many times in the past three months have you felt excessive hunger?
1 2 3 4 5
3. How many times in the past three months have you had frequent urination related to
diabetes management?
1 2 3 4 5
Financial Worries
The following set of questions will help us know how your diabetes has affected your or your
family’s finances. Please tick any one option….
1. What do you think about the cost involved in your management of diabetes?
Very expensive little expensive reasonable not at all Expensive
1 2 3 4 5
2. To what extent has your priority of expenditure shifted towards diabetes management?
1 2 3 4 5
3. To what extent has your family budget got affected by the expenses related to the
management of diabetes?
1 2 3 4 5
4. To what extent has your diabetes limited your expenditure on other aspects of life (Movies,
outings, parties etc)?
1 2 3 4 5
Emotional/Mental Health
1. How satisfied are you with yourself?
y
Satisfied
1 2 3 4 5
2. How satisfied are you with your personal relationship(family, friends,relatives and known tos)
35
y
Satisfied
1 2 3 4 5
3. How satisfied are you with the emotional support you get from your friends and family?
y
Satisfied
1 2 3 4 5
4. How often are you discouraged by your health problems?
1 2 3 4 5
5. All people want to fulfill certain roles and lead their lives in a purposeful manner. To what
extent do you feel that you have been able to lead your life in the same way?
1 2 3 4 5
Diet Satisfaction
Diabetes demands a little modification in diet, thus the following set of questions would help us
know how much satisfied you are with modifications in your diet.(For participants who have
been advised some dietary modification/counseling).
1. How often do you feel because of your diabetes a restriction in choosing your food when
eating out?
1 2 3 4 5
2. As you have diabetes, how much choice do you feel you have in eating your meals or snacks
away from home e.g. if you go in a party and there is a buffet where there are also a lot of fried
snacks and desserts would you be able to make enough choice?
No choice Very little little enough A lot
1 2 3 4 5
3. How often do you eat the food items that you shouldn’t, in order to hide the fact that you are
having diabetes.
1 2 3 4 5
QOLID Score:
SCALE NUMBER OF ITEMS AVERAGE OF THE ITEMS
Role Limitation Due to Physical 6
Health
36
Physical Endurance 6
General Health 3
Treatment Satisfaction 4
Symptom Botherness 3
Financial Worries 4
Emotional/Mental Health 5
Diet Satisfaction 3
Date _______________ Signature of Invigilator_________________________
37

Protocol & Case Report Forms (CRF)

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Protocol & Case Report Forms (CRF)

Uploaded by

Copyright:

Available Formats

COMPARATIVE EFFECTIVENESS OF ‘NISAKATHAKADI KASHAYAM AND

KATHAKAKHADIRADI KASHAYAM’ IN TYPE 2 DIABETES MELLITUS

PROTOCOL & CASE REPORT FORMS (CRF)

Title of Study: COMPARATIVE EFFECTIVENESS OF ‘NISAKATHAKADI KASHAYAM AND

Broad Subject : Health Science

Sub Area : Diabetes mellitus

Duration in months : 24 months

Total estimated cost : 10,06,750 rupees

Funding & Administration : Kerala University of Health Science (KUHS), Thrissur

Study Category : Applied Research

Principal Investigator : Dr.V.N.Radhakrishnan

Institute Name : Govt Ayurveda Medical College, TVPM

Co-Investigator : Dr.P.V Giri

Institute Name : Vaidyaratnam Ayurveda College

Co-Investigator : Dr Prakash Mangalasseri

Institute Name : V.P.S.V Ayurveda College

Co-Investigator : Dr.Sreelatha Chandroth

Designation : Associate Professor

Institute Name : Govt Ayurveda College, Kannur

Co-Investigator : Dr.Sunil John Thykkattil

Designation : Assistant Professor

Institute Name : Govt Ayurveda College, Trippunithura

Designation : Assistant Professor

Institute Name : Govt Ayurveda College, Thiruvananthapuram

Diabetes mellitus (DM) is a metabolic disorder resulting from a defect in insulin

Ayurvedic herbs namely Gymnema sylvestere, Momordica charantia, Trigonella

Defining the problems

Relevance & Importance for the study

 To identify the role of Ayurveda as a supportive measure in non communicable diseases

 To evaluate the hypoglycemic effect of Nisakathakadi Kashaya in Type 2 DM.

Study design - Observational design

1. Govt. Ayurveda College, Thiruvananthapuram, Kerala.

2. Govt. Ayurveda College,, Trippunithura, Ernakulam, Kerala.

3. Govt. Ayurveda College, Kannur, Kerala.

4. Vaidyaratnam Ayurveda College, Ollur, Thrissur, , Kerala and

5. V.P.S.V Ayurveda College, Kottakkal, Malappuram, Kerala.

Duration of Study : 24 months

Observation Period : 120 days

Group I – Type 2 DM patients those who will be given Nisakathakadi kashayam.

Group II – Type 2 DM patients those who will be given Kathakakhadiradi kashayam.

Materials & methods

In Group I - Nisakathakadi Kashaya

In Group II - Kathakakhadiradi Kashaya

Time : One hour prior to Breakfast and Dinner

Duration : 120 days

CRITERIA FOR INCLUSION (Group I & II)

1. Age between 30 years to 60 years

2. Satisfying any of the three:-

PPBS > 160 mg/dl and<= 240 mg/dl or

Glycated haemoglobin>7% and <9 %

CRITERIA FOR EXCLUSION(Group I & II)

1. Those who are under Insulin therapy.

2. Established case of IHD/Stroke

3. Pregnant woman or the women planning to be pregnant in next six months

6. Patient with Serum creatinine ≥ 1.5mg/dl

7. Patient with diabetic foot/ Nephropathy

CRITERIA FOR WITHDRAWAL

1. Fasting plasma glucose with no caloric intake for at least 8 hour

2. Two hour postprandial plasma glucose

DEFINING AND METHOD OF ESTIMATING THEM

1. Case record form

2. Questionnaire for assessment of Health Related Quality of life (HRQOL)

METHODS OF DATA COLLECTION

Date: _ Signature___

Date:_ Name of the Subject:____________

Date: Name of witness:____________

Date: Signature of the Investigator _