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CTRI Number  CTRI/2021/08/035466 [Registered on: 05/08/2021] Trial Registered Prospectively
Last Modified On: 04/08/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Yoga on COVID 19 
Scientific Title of Study   “Yoga Based Rehabilitation Program for patients with successfully treated COVID 19”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Upendra Baitha 
Designation  assistant professor 
Affiliation  AIIMS New Delhi 
Address  Dept of Medicine AIIMS New Delhi

South
DELHI
110029
India 
Phone  01126593303  
Fax    
Email  drupendraraj14@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Upendra Baitha 
Designation  assistant professor 
Affiliation  AIIMS New Delhi 
Address  Dept of Medicine AIIMS New Delhi

South
DELHI
110029
India 
Phone  01126593303  
Fax    
Email  drupendraraj14@gmail.com  
 
Details of Contact Person
Public Query  
Name  Upendra Baitha 
Designation  assistant professor 
Affiliation  AIIMS New Delhi 
Address  Dept of Medicine AIIMS New Delhi

South
DELHI
110029
India 
Phone  01126593303  
Fax    
Email  drupendraraj14@gmail.com  
 
Source of Monetary or Material Support  
DST/SATYAM/COVID-19/2020/336(G) GOVERNMENT OF INDIA MINISTRY OF SCIENCE & TECHNOLOGY DEPARTMENT OF SCIENCE &TECHNOLOGY KIRAN DIVISION TECNOLOGY BHAVAN NEW MEHRAULI ROAD NEW DELHI-110016  
 
Primary Sponsor  
Name  DST Satyam 
Address  New Delhi 
Type of Sponsor  Government funding agency 
 
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 Upendra Baitha  AIIMS New Delhi  ROOM 3094 A DEPT OF MEDICINE 3RD FLOOR TEACHING BLOCK Ansari Nagar
South
DELHI 		 01126593303

drupendraraj14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institute ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard treatment   post covid discharged patient will be given standard treatment  
Intervention  yoga therapy  post covid 19 discharged patient will be given yoga therapy for 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients age more than 18 years who have been discharged after being admitted for the treatment of COVID 19.
2. Patients required assisted respiratory therapy (O2 therapy, BiPaP ventilation or Mechanical ventilation) during Hospital stay.
3. Willing to participate and give consent
 
 
ExclusionCriteria 
Details  1. Patients with known severe irreversible pulmonary diseases before getting infected with COVID 19 like COPD, ILD, Bronchiectasis needing domiciliary O2 therapy.
2. Patients with severe obesity of musculoskeletal diseases making them unfit for practising Yoga.
3. Severe end organ damage or chronic diseases: renal/ hepatic failure, any malignancy etc. that can lead to unfit for yoga practices.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Yoga based rehabilitation program (Standard care with yoga sessions) will be more effective than standard care alone in post discharge recovery of moderately to severely ill patients with COVID 19.  we will assess outcime measures after 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
not applicable  not applicable 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/08/2021 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drupendraraj14@gmail.com].

  6. For how long will this data be available start date provided 29-07-2022 and end date provided 28-12-2022?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   COVID-19 has gained the status of a pandemic. For rapid recovery from distress and ensuring over all well being, treatment programs are required for cured patients. Since, the respiratory system and mental health are compromised due to novel corona virus infection so yoga might prove to be helpful as an alternative therapy for the recovered patients of COVID-19. 
we hypothesize that Yoga based rehabilitation program will be more effective than standard care alone in post discharge recovery of moderately to severely ill patients with COVID 19. Moderate to severe patients after discharge from AIIMS New Delhi or patients who will visit to Medicine / pulmonary Medicine OPD will be recruited for the study. Based on the allocation of the group after randamization each participant will be either standard care or standard care with yoga. standard care will include dietry counselling, drugs or surgery as per indication. Yoga session will be provided to recovered participatients by yoga therapist. outcome will be measured by 6 minute walk test, pulmonary function test, and breath holding test.
Each qualitative and quantative values obtained by the study will be express as absolute and relative frequency, where as continuos variable may be organised as mean(SD) and / or median(range). Other appropriate methods will be used according to the data obtained.
 
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