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CTRI Number  CTRI/2023/01/049241 [Registered on: 25/01/2023] Trial Registered Prospectively
Last Modified On: 09/01/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   INFLUENCE OF YOGA ON IMMUNITY AND COGNITION IN LONG-TERM YOGA PRACTITIONERS AND NON-YOGA PRACTITIONERS 
Scientific Title of Study   INFLUENCE OF YOGA ON MARKERS OF IMMUNOSENESCENCE, INFLAMMATION AND COGNITION IN LONG-TERM YOGA PRACTITIONERS AND YOGA NAÏVE INDIVIDUALS – A STRATIFIED, CROSS-SECTIONAL STUDY  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manjunath NK 
Designation  Director of Research, Dept. of Life Sciences 
Affiliation  SVYASA 
Address  Anveshana Research Laboratory
Kalluballu Post, Anekal, Swami Vivekananda Rd, Jigani, Karnataka
Bangalore
KARNATAKA
560105
India 
Phone    
Fax    
Email  nkmsharma@svyasa.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijaya Majumdar 
Designation  Associate Professor, Dept. of Life Sciencces 
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA) 
Address  Anveshana Research Laboratory, 1st floor
Kalluballu Post, Anekal, Swami Vivekananda Rd, Jigani, Karnataka
Bangalore
KARNATAKA
560105
India 
Phone  9036800821  
Fax    
Email  vijaya.majumdar@svyasa.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Vijaya Majumdar 
Designation  Associate Professor, Dept. of Life Sciencces 
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA) 
Address  Anveshana Research Laboratory, 1st floor
Kalluballu Post, Anekal, Swami Vivekananda Rd, Jigani, Karnataka
Bangalore
KARNATAKA
560105
India 
Phone  9036800821  
Fax    
Email  vijaya.majumdar@svyasa.edu.in  
 
Source of Monetary or Material Support  
Dr. N K Manjunath, Director of Research, Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA) Kalluballu Post, Anekal, Swami Vivekananda Rd, Jigani, Karnataka  
 
Primary Sponsor  
Name  Swami Vivekananda Yoga Anusandhana Samsthana 
Address  Kalluballu Post, Anekal, Swami Vivekananda Rd, Jigani, Karnataka  
Type of Sponsor  Research institution and hospital 
 
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 Vijaya Majumdar  Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA)  Anveshana Research Laboratory 1st floor
Bangalore
KARNATAKA 		 9036800821

vijaya.majumdar@svyasa.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SVYASA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Long-term yoga practitioners and Yoga naive participants 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Long-term practitioners minimum 3 years and maximum 10 years of practice. Yoga session includes asana, pranayama, meditation
Yoga naive practitioners who are age matched and who are physically active
 
 
ExclusionCriteria 
Details  Those who have undergone recent surgery, acute infection, fever, or any allergy during the past 3 months. Participants with uncontrolled diabetes and hypertension and psychological disorders will be excluded from the study. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Status of immunosenescence markers and inflammatory markers  one time point 
 
Secondary Outcome  
Outcome  TimePoints 
Cognition markers   one time point 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   01/07/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [vijaya.majumdar@svyasa.edu.in].

  6. For how long will this data be available start date provided 01-12-2023 and end date provided 01-12-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Aging leads to undesirable changes in physical and psychological health associated with aging. Yoga is a holistic practice which is shown to successfully modulate the mind and thus effective in curbing these changes. There is evidence to suggest that mind-body therapies greatly help in combating the downfall of immune system, prevent cognitive decline and reduce inflammaging. Yoga not only help prevent but also reverse these changes paving the way for a better future in elderly care. 
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