| CTRI Number |
CTRI/2018/01/011123 [Registered on: 03/01/2018] Trial Registered Prospectively |
| Last Modified On: |
02/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Exercise, Yoga and Fixed diet regime] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study effect of Darvyadi yoga in patients of Madhumeha (Type 2 Diabetes Mellitus). |
|
Scientific Title of Study
|
A Comparative Study on aetiopathogenesis and management of Madhumeha (Type 2 Diabetes Mellitus)with Darvyadi yoga. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Umesh Kumar Sapra |
| Designation |
Assistant Professor |
| Affiliation |
Ch. Brahm Prakash Ayurved Charak Sansthan. |
| Address |
Department of Rog Nidan Evum Vikriti Vigyan
Ch. Brahm Prakash Ayurved Charak Sansthan.
Khera Dabar Najafgarh New Delhi.
Khera Dabar Najafgarh New Delhi.
New Delhi
DELHI
110073
India |
| Phone |
8368608139 |
| Fax |
|
| Email |
umeshsapra123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh Kumar Sapra |
| Designation |
Assistant Professor |
| Affiliation |
Ch. Brahm Prakash Ayurved Charak Sansthan. |
| Address |
Department of Rog Nidan Evum Vikriti Vigyan
Ch. Brahm Prakash Ayurved Charak Sansthan.
Khera Dabar Najafgarh New Delhi.
Khera Dabar Najafgarh New Delhi.
New Delhi
DELHI
110073
India |
| Phone |
8368608139 |
| Fax |
|
| Email |
umeshsapra123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Umesh Kumar Sapra |
| Designation |
Assistant Professor |
| Affiliation |
Ch. Brahm Prakash Ayurved Charak Sansthan. |
| Address |
Department of Rog Nidan Evum Vikriti Vigyan
Ch. Brahm Prakash Ayurved Charak Sansthan.
Khera Dabar Najafgarh New Delhi.
Khera Dabar Najafgarh New Delhi.
New Delhi
DELHI
110073
India |
| Phone |
8368608139 |
| Fax |
|
| Email |
umeshsapra123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ch. Brahm Prakash Ayurved Charak Sansthan |
|
|
Primary Sponsor
|
| Name |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar Najafgarh New Delhi 110073 |
| Type of Sponsor |
Other [State Government Ayurvedic College] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Rog Nidan Evum Vikriti Vigyan |
Ch. Brahm Prakash Ayurved Charak Sansthan khera Dabar Najafgarh New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Umesh Kumar Sapra |
Ch. Brahm Prakash Ayurved Charak Sansthan Hospital |
OPD number 20 and 22 of Atyayika chikitsha and Rog nidan
New Delhi
DELHI |
8368608139
umeshsapra123@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Ch Brahm Prakash Ayurved Charak Sansthan |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients of Type 2 Diabetes Mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Darvyadi Yoga |
Darvyadi yoga 1gm TDS for 60 days,Exercise Yoga and Fixed diet regime |
| Comparator Agent |
No treatment |
Exercise, Yoga and Fixed Diet regime for 60 days |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Fasting Blood Sugar >126mg/dl and < 200 mg/dl.
Patient with Post Prandial Blood Sugar >200mg/dl and < 350mg/dl.
Patients with classical signs and symptoms of type 2 diabetes with Random Blood Sugar > 200mg/dl and < 300mg/dl.
Patients with HbA1c > 6.5% and <10%.
Patient recently diagnosed (for less than 3 months) as diabetic and not taking any medication.
Patients willing to participate in study, to follow given instructions and give informed consent for a period of 60 days.
|
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| ExclusionCriteria |
| Details |
1. Patients aged below 30 years and above 65 years.
2. Patients with Fasting Blood Sugar > 200mg/dl.
3. Patients with Post Prandial Blood Sugar > 350mg/dl.
4. Patients with Random Blood Sugar > 300mg/dl.
5. Patients with type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus and secondary diabetes.
6. Drug induced Diabetic patients, due to endocrinopathies (Acromegaly, Cushing’s syndrome).
7. Patients on prolonged medications with antidepressants etc.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
1. Relief in cardinal signs & symptoms of patients.
2. Decrease in elevated levels of FBS, PPBS, HbA1c, Lipid profile, and other bio chemical parameters.
|
60 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Aetiopathogenesis of Madhumeha will be assessed by adopting suitable scoring methods.
2. Subjective improvement in the patient will be assessed by adopting suitable scoring methods.
3. The observation of prevalence of the disease among patients will be assessed by other possible data of age, sex, education, family history, economical status, occupation, life style, food habits etc.
|
60 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Madhumeha is a type of vataj prameha. Prameha are a list of urinary disorders, especially characterized by profuse urination with several abnormal qualities due to dosha imbalances. Morbidity and mortality must have been very high due to madhumeha in the past therefore it is enlisted among ‘Ashta mahagada in charak samhita. Madhumeha has been extensively described in ayurvedic texts of all times including brihatrayi and laghutrayi. Ayurvedic remedies for madhumeha are the oldest among all the available therapies, which includes in prameha category. These therapies involve shamana, shodhana, diet and life style changes and yoga in a number of forms with vivid variety of drugs. In parlance to diabetes a lot is yet unexplored in understanding and treatment of Madhumeha in light of Ayurveda. Darvyadi yoga is mentioned in Charak Samita Chikitsha sthana chapter 6/26. Contents of drug are Devdaru, Daruharidra, Musta and Triphala. India has gained status of potential epidemic with more than 62 million Diabetic individuals. India has been projected by World Health Organization as the country with fastest growing population of diabetic patients. There is no authentic, standardized drug/ drugs developed by Ayurveda followers or researchers so far which can decline the elevated blood sugar level. This research work aims at studying Madhumeha for its etiopathogenesis and management in parlance to Type 2 Diabetes Mellitus.
Assessment Criteria : Objective parameters like FBS, PPBS, HbA1c and others will be assessed by laboratory investigations before and after treatment. Subjective improvement in the patient will be assessed by adopting suitable scoring methods. Study Type:Randomized Comparative clinical trial Study time: 2 years Intervention time: 60 days Sample size: 120 (60 in each group) Group A: Darvyadi yoga 1 gm TDS before meal, Exercise, Yoga and fixed diet regimen Group B: Exercise, Yoga and fixed diet regimen
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