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CTRI Number  CTRI/2022/05/042411 [Registered on: 09/05/2022] Trial Registered Prospectively
Last Modified On: 27/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Other (Specify) [Rajyoga Meditation]  
Study Design  Other 
Public Title of Study   Benifit of Yoga and Rajyoga meditation on symptomatic post-Covid-19 patients  
Scientific Title of Study   Effectiveness of Yoga and Rajyoga meditation in improving quality of life of symptomatic post-Covid-19 Indian participants  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sujatha Prabhu P 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education Manipal 
Address  Department of Physiology Melaka Manipal Medical College MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  9964585737  
Fax    
Email  sujatha.prabhu@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr M G Ramesh Babu 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education Manipal 
Address  Department of Physiology Melaka Manipal Medical College MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  9611362075  
Fax    
Email  ramesh.babu@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sujatha Prabhu P 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education Manipal 
Address  Department of Physiology Melaka Manipal Medical College MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  9964585737  
Fax    
Email  sujatha.prabhu@manipal.edu  
 
Source of Monetary or Material Support  
Melaka Manipal Medical College Manipal 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Madhav Nagar Manipal - 576104 
Type of Sponsor  Private medical college 
 
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 Sujatha Prabhu P  Melaka Manipal Medical College, MAHE, Manipal  Department of Physiology Multidiciplinary Laboratory 3rd Floor
Udupi
KARNATAKA 		 9964585737

sujatha.prabhu@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: U071||COVID 19 virus identified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  Post Covid-19 symptomatic patients 
Intervention  Yoga and Rajyoga meditation  Survey conducted for Post Covid-19 symptomatic patients and intervention will be given with yoga and Rajyoga meditation for the period of one month. Total period of the study is 3 months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Participants who will not be practicing Yoga or meditation in their routine day to day life will be included.

Participants with post COVOD-19 symptoms (One month after discharge from hospital or isolation) having American Association of Anesthesiologist (ASA) score I/II will be included in the control /intervention groups.

Participants who will be taking any type of medication including for sleep/anxiety are permitted to be included in the study.
 
 
ExclusionCriteria 
Details  Participants with ASA score III or more will be excluded from the study.

Individuals who practice pranayama or meditation regularly (more the 3 days in a week).

Individuals below 18 years and above 65 years of age will be excluded from the study.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Identify the current prevalence of long-term debilitating effects in post COVID-19 symptomatic Indian
adult patients which are lacking. Assist in the clinical management of post-COVID-19 symptomatic
Indian patients by rehabilitation techniques or preventive measures using Yoga (mainly pranayama) and
particularly RM to mitigate their debilitating effect or symptoms particularly related to cerebral
cardiovascular and respiratory problems and improve quality of life. 		 one month 
 
Secondary Outcome  
Outcome  TimePoints 
Identify the underlying scientific basis for any improvement in physiological parameters [HRV, EMG, EEG and respiratory parameters
(FVC, FEV1, TLC, PEFR, VO2 max)] tested in chronic post-COVID-19 symptomatic Indian patients subsequent to interventions with Yoga & RM. 		 3 months 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   09/05/2022 
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  
COVID-19 infected patients may present sequelae of medical problems with perseverance, lasting several weeks to months after recovery. It is not clear, how the viral load and comorbidities would affect the risk of evolving long-term COVID-19 complications. There is a need for follow-up and care for survivors recovering from COVID-19. Pulmonary function tests were more evident in critical COVID-19 patients when compared with moderate illness. Evidence supports the benefits of yoga in the management of stress as well as in chronic non-communicable diseases. However, there is no evidence available on the effects of yoga and Rajyoga meditation practice on post-COVID-19 symptomatic participants and very few studies elaborate their importance in communicable diseases, especially in acute and rapidly spreading infections, resulting in pandemics like COVID-19. Thus, there is a need for rehabilitation and improvement in the quality of life in post-COVID-19 symptomatic patients. Based on the existing scientific evidence on yoga, pranayama and Rajyoga meditation in improving respiratory and immune functions, a formulated yoga module and regular Rajyoga meditation practice will be employed in this study, to help in mitigating the long-term side effects of COVID-19 infection in adults. Thus, the purpose of the current study is to compare and correlate the findings from physiological parameter tests (HRV, EMG, EEG, and pulmonary function tests) between asymptomatic volunteers who will serve as control and post COVID-19 symptomatic participants and mitigating effectiveness of pranayama and RM practice on these parameters in post-COVID-19 symptomatic participants.
 
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