| CTRI Number |
CTRI/2021/07/035027 [Registered on: 22/07/2021] Trial Registered Prospectively |
| Last Modified On: |
20/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of a Video Based Yoga protocol for patients recovered from Covid-19 |
|
Scientific Title of Study
|
Efficacy of A Virtual, Video-based regular Yoga Protocol on the immune function, antioxidant status, stress hormone responses and psychological components in healthy population and patients recovered from COVID-19 in COVID pandemic Period: A randomized control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ishwar V Basavaraddi |
| Designation |
Director |
| Affiliation |
Morarji Desai National Institute of Yoga |
| Address |
Ministry of AYUSH Govt of India
68 Ashoka Road New Delhi
New Delhi
DELHI
110001
India |
| Phone |
01123720417 |
| Fax |
|
| Email |
ibasavaraddi@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudip Kumar Dutta |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dept. of Laboratory medicine All India Institute of Medical Sciences Ansari Road Delhi
New Delhi
DELHI
110029
India |
| Phone |
01126593705 |
| Fax |
|
| Email |
dr.sudipdatta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ishwar V Basavaraddi |
| Designation |
Director |
| Affiliation |
Morarji Desai National Institute of Yoga |
| Address |
Ministry of AYUSH Govt of India
68 Ashoka Road New Delhi
New Delhi
DELHI
110001
India |
| Phone |
01123720417 |
| Fax |
|
| Email |
ibasavaraddi@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of laboratory medicine All India Institute of Medical Sciences Delhi |
| Department of Yoga Research Morarji Desai National Institute of Yoga New Delhi
68 Ashoka Road Delhi 01 |
|
|
Primary Sponsor
|
| Name |
Ministry of AYUSH |
| Address |
AYUSH Bhawan, GPO Complex, INA, New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudip Kumar Dutta |
Department of Laboratory Medicine |
All India Institute of Medical Sciences Ansari Nagar East New Delhi
New Delhi
DELHI |
01126593705
dr.sudipdatta@gmail.com |
| Dr Ishwar V Basavaraddi |
Morarji Desai National Institute of Yoga |
Room Dept. of Yoga Research, 68 Ashoka Road New Delhi
Ministry of AYUSH
Govt of India
New Delhi
DELHI |
9810800289
ibasavaraddi@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IECAIIMS |
Approved |
| INSTITUTIONAL ETHICAL COMMITTEE MDNIY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adults and Recovered COVID-19 patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Virtual video based regular Yoga |
A 45 minutes virtual yoga programme video designed by experts in the field of yoga will be administered to the healthy individuals. |
| Intervention |
Virtual video based regular Yoga |
A 45 minutes virtual yoga programme video designed by experts in the field of yoga will be administered to the recovered patients COVID 19. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Willingness to participate in the study.
Age between 20-65 years.
Individuals who have Indian nationality.
Access to the internet/smartphone/laptop to watch virtual video based yoga sessions.
|
|
| ExclusionCriteria |
| Details |
Individuals suffering from any kind of chronic diseases.
Individuals with physical limitations making them unable to perform yoga asanas.
Individuals with a history of alcohol abuse or smoking more than 5 cigarettes a day.
Individuals taking any kind of medications.
Individuals who are severely overweight (BMI> 35).
Individuals working in night shifts. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in the level of multiple cytokines.
Reduction in oxidative stress parameters such as malondialdehyde and F2-isoprostane.
Improvement in antioxidant components such glutathione, catalase and superoxide dismutase activities.
Reduction in stress hormones levels.
Improvement in the scores of DASS.
|
The assessment will be done at baseline (pre-intervention assessment) at 3 months and at 6 months (post intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Impact of Yoga practice on oxidative stress, antioxidant components, immune functions, and secretion of stress hormones, in healthy individuals and in patients who have recovered from Covid 19 infection.
Impact of Covid 19 infections on bio-parameters, such as oxidative stress, antioxidant components, immune functions, and secretion of stress hormones, in patients who have recovered from Covid 19 infections compared to healthy individuals. |
At baseline (0 day pre-intervention assessment) , 3 months and 6 months (post-intervention assessment) |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
23/07/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be conducted on two parallel parts. Part A will consist of a healthy population and Part B will include the COVID-19 recovered patients. A total of 50 in each arm will be recruited for the study. Intervention based on the allocation of group after randomization each participant will be given either Standard care or Comprehensive treatment module. Standard care will include medical management if required and general counselling including dietary counseling and physical activity advice. A Yoga based intervention module will be developed. After the development, the module will be sent to different experts for peer view and rating of different components of the module will be done. The internet-based yogic intervention will be delivered in the form of videos. It includes yogic exercise. It aims to balance mental and physical health through breathing techniques (Pranayama), postures (Asana), and meditation (Dhyana). The trial is expected to be completed within one year.
|