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CTRI Number  CTRI/2024/08/071842 [Registered on: 02/08/2024] Trial Registered Prospectively
Last Modified On: 01/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Other 
Public Title of Study   Effect of community-based Yoga Program on diabetes, blood pressure, lipid profile and wellness in Community Setting 
Scientific Title of Study   A randomized controlled trial to see effect of community-basedYoga Program on diabetes, blood pressure, lipid profile and wellness in Rural and Tribal Community Setting, and its feasibility to integrate with Health and Wellness centres (HWC) in the country 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Puneet Misra 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no 30 Centre for Community Medicine Old OT Block AIIMS New Delhi

South
DELHI
110029
India 
Phone  01126593773  
Fax    
Email  drpuneetresearch@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Puneet Misra 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no 30 Centre for Community Medicine Old OT Block AIIMS New Delhi


DELHI
110029
India 
Phone  01126593773  
Fax    
Email  drpuneetresearch@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Puneet Misra 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no 30 Centre for Community Medicine Old OT Block AIIMS New Delhi


DELHI
110029
India 
Phone  01126593773  
Fax    
Email  drpuneetresearch@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, New Delhi 
 
Primary Sponsor  
Name  Indian Council of Medical Research  
Address  Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Puneet Misra  All India Institute of Medical Sciences, New Delhi  Centre for Community Medicine, Old OT Block
South
DELHI 
9810696386

doctormisra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  General population at least 18 years of age or above 18 years to 65 years of age Willing to participate, give consent and continue yoga practice Living in community for at least 6 months  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable. We will offer intervention to the wait-listed control group as per standard practice once the study participant completes follow-up.   We will compare these findings from the area in the wait-listed control arm of study where we will continue to give routine intervention as per standard practice once the study participant completes follow up. These individuals will be followed up for a total of twelve months. They will be evaluated at three, six and twelve months from baseline data.  
Intervention  Structured yoga program   Structured Yoga Program developed by trained personnel from Centre for Integrated Medicine and Research AIIMS, New Delhi will be used for the study as an intervention program. Two-week intensive yoga training at community setting (rural and tribal), followed by yoga at a place convenient to them for next 10 weeks with biweekly home visits by research staff and yoga instructor to see compliance with offer to help if any required for training there. Participants will be encouraged to continue yoga same way, unsupervised after 12 weeks to see long term feasibility, however they will be offered help if they actively seek by contacting us to make them self-reliant. These individuals will be followed up for a total of twelve months and effect will be evaluated after three, six and twelve months from baseline data. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  - General population at least 18 years of age or above 18 years to 65 years of age
- Willing to participate, give consent and continue yoga practice
- Living in community for at least 6 months
 
 
ExclusionCriteria 
Details  - Any major illness which limits their capability to do yoga
- Pregnant women
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Positive outcome of yoga on diabetes, lipid profile,blood pressure and wellness, in rural and tribal areas  3 6 and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
To comprehend the feasibility of impregnating structured yoga program in low- and middle-income socio-economic community setting which would provide evidence for policy making to integrate it with Health and Wellness Centers (HWCs) and help in making sustainable and effective community setting-based yoga intervention program for larger populations for control and prevention of diabetes and other health related issues all over the country in different settings   3 6 and 12 months 
 
Target Sample Size   Total Sample Size="384"
Sample Size from India="384" 
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 2 
Date of First Enrollment (India)   15/08/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Background: In view of the rising burden of type 2 diabetes mellitus (DM) cases in India, there is an urgent need for an effective, low‐cost, sustainable intervention to control diabetes thus preventing complications. We plan to study the role of yoga in rural and tribal community settings among diabetics to see the impact of yoga in real-life community-based settings rather than facility-based experimental settings with integration to Health and Wellness Centres (HWC). 

Yoga has been seen to be beneficial not only in preventing these diseases but also in treatment of many of these.  However, most of studies have been done in a facility based setting, and once person go out of it, many of them discontinue it. 

Novelty: This study looks at the effect of yoga done in a community setting at doorstep along with looking feasibility of yoga in field setting.  We have successfully demonstrated in urban community.  To replicate it for masses, we need to demonstrate benefits in rural and tribal communities too, along with exploring challenges and its solutions for field-based yoga implementation in these communities. More importantly we are looking to integrate it with Health and wellness centres (HWCs) under Ayushman Bharat for long term sustainability for huge rural and tribal population of the country even in remotest areas so as to make it successful for this underprivileged group while controlling NCDs such as Diabetes Mellitus. In essence, by integrating various discrete stages of usual research design, we provide a superior methodology in making yoga a “Jan-Andolan”. Furthermore, to our knowledge, no community-based study has been conducted in rural and tribal area on effect of structured yoga program on diabetes, hypertension and wellness.

 
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