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CTRI Number  CTRI/2025/08/092555 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 06/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Single Arm Study 
Public Title of Study   Yoga for osteoarthritis related pain 
Scientific Title of Study   Effect of Integrated Approach Of Yoga Therapy on the Pain, Depression, KOOS and Quality of Life in Osteoarthritis Participants 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ved Prakash 
Designation  MSc student 
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana 
Address  Swami Vivekananda Yoga Anusandhana Samsthana Vivekananda Road Division of Yoga & Life science Research Department Kallabalu(Post) Jigani Bengaluru

Bangalore Rural
KARNATAKA
560105
India 
Phone  9368370342  
Fax    
Email  vedpk555@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Nair 
Designation  Asst. Professor 
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana 
Address  Swami Vivekananda Yoga Anusandhana Samsthana Division of Yoga & Life science Anvesana Research Labs Vivekananda Road Kallabalu(Post) Jigani Bengaluru

Bangalore Rural
KARNATAKA
560105
India 
Phone  9632164777  
Fax    
Email  rajeshnair@svyasa.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Rajesh Nair 
Designation  Asst. Professor 
Affiliation  SVYASA 
Address  Swami Vivekananda Yoga Anusandhana Samsthana Division of Yoga & Life science Anvesana Research Labs Vivekananda Road Kallabalu(Post) Jigani Bengaluru


KARNATAKA
560105
India 
Phone  9632164777  
Fax    
Email  rajeshnair@svyasa.edu.in  
 
Source of Monetary or Material Support  
SVYASA yoga university 
 
Primary Sponsor  
Name  Arogyadhama Holistic Research Health Home 
Address  Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA) Bengaluru 
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 Amit Singh  Arogyadhama - Holistic Research Health Home  Room: D-section Division of Yoga & Lifescience Research Department Prashanti Kutiram Kallubalu Post Jigani
Bangalore Rural
KARNATAKA 		 08022639963

arogyadhama@svyasa.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) - SVYASA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Integrated therapy of yoga  Asana, Pranayama, Meditation for 2 weeks, day long programs with multiple sessions. 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Male and female subjects identified with Osteo Arthritis condition
Age: 30 to 65 years
Subjects ready to give consent for participating in the study
 
 
ExclusionCriteria 
Details  Those who have severe knee injury
Those who had participated in any study with yoga intervention in last 6 months
Subjects undergone any surgery at knee.
Subjects having any other severe health conditions that may interfere with the yoga practices of the requirements of the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Osteo arthritic pain
Knee injury and osteoarthritis outcome Score
Depression
Quality of life
 		 Baseline & after 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/10/2025 
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="14" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
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-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response -  Analytic Code

  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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vedpk555@gmail.com].

  6. For how long will this data be available start date provided 01-11-2025 and end date provided 01-11-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

This study was aimed at observing the effect of an integrated approach of yoga therapy on the pain, depression, Koos, and quality of life in osteoarthritis participants.

 
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