| CTRI Number |
CTRI/2017/11/010455 [Registered on: 10/11/2017] Trial Registered Prospectively |
| Last Modified On: |
26/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of yoga on glucose changes in diabetes patients |
|
Scientific Title of Study
|
Effect of Yoga on Ambulatory Glucose Profile in patients with Type 2 Diabetes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Venugopal V |
| Designation |
Scientist |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
4, Conron Smith Rd, Gopalapuram, Chennai
Chennai
TAMIL NADU
600086
India |
| Phone |
9449223830 |
| Fax |
|
| Email |
dr.venu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venugopal V |
| Designation |
Scientist |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
4, Conron Smith Rd, Gopalapuram, Chennai
TAMIL NADU
600086
India |
| Phone |
9449223830 |
| Fax |
|
| Email |
dr.venu@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Mavathur |
| Designation |
Guide/ Professor |
| Affiliation |
S-VYASA Yoga University |
| Address |
19, ‘Eknath Bhavan’, Gavipuram Circle,
Kempe Gowda Nagar
Bangalore
KARNATAKA
560019
India |
| Phone |
9611161845 |
| Fax |
|
| Email |
rameshmavathur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madras Diabetes Research Foundation
4, Conron Smith Rd, Gopalapuram, Chennai- 600086, Tamilnadu |
|
|
Primary Sponsor
|
| Name |
TVS Motor company |
| Address |
Harita, Krishnagiri district Hosur, Tamilnadu |
| Type of Sponsor |
Other [Motor company- Donation under CSR initiative] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Venugopal V |
Madras Diabetes Research Foundation (MDRF) & Dr.Mohans Diabetes Specialities Centre |
Department of Yoga and Physical Activity
No.6-B, Conron Smith
Road, First Floor (Near Satyam
Cinemas),
Gopalapuram, Chennai-
600086
Chennai
TAMIL NADU |
9449223830
dr.venu@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee - Madras Diabetes Research Foundation (MDRF) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Type 2 diabetes mellitus, (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Physical exercise |
30 minutes of walking per day |
| Intervention |
Yoga |
Including asanas, pranayama and meditation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
HbA1C greater than equal to 8% |
|
| ExclusionCriteria |
| Details |
1. Proliferative retinopathy (PDR)
2. Chronic kidney disease (stage 4,5 and on renal replacement
therapy)
3. Coronary artery disease (CAD) with symptoms of angina or angina
equivalent
4. Congestive Heart failure with NHYA class 3 and 4
5. Advanced arthritis restricting movements while performing yoga
practices
6. Severe painful neuropathy and/or foot ulcers
7. Pregnant women
8. Practitioners of yoga in the past 3 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Estimated daily averages and standard
deviation and co-efficient of variation (SD/Sqrt
mean) of glucose values |
Day 0, Day 7 and
Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time within euglycaemia
2. Time above the glycaemic target
3. Time below the glycaemic target |
Baseline and Day 14 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
04/12/2017 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
None yet
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study is to see the effect of yoga on glycaemic variability in type 2 diabetes mellitus. The study has been successfully completed and manuscript is under preparation as on 26/12/2019 |