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CTRI Number  CTRI/2018/05/014030 [Registered on: 21/05/2018] Trial Registered Retrospectively
Last Modified On: 17/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to know the effect of yoga on HIV positive individuals 
Scientific Title of Study   Role of Integrated Approach of Yoga Therapy in Modifying Immune Responses, Quality Of Life and Cognitive Functions in HIV Seropositive individuals 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  M N Ramesh 
Designation  Professor 
Affiliation  SVYASA 
Address  Anveshana Research Center, SVYASA University Campus, Kallabalu Post,, Jigani, Anekal Taluk, Bengaluru District, Karnataka State, India.

Bangalore
KARNATAKA
560105
India 
Phone    
Fax    
Email  ramesh.mavathur@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  M N Ramesh 
Designation  Professor 
Affiliation  SVYASA 
Address  Anveshana Research Center, SVYASA University Campus, Kallabalu Post,, Jigani, Anekal Taluk, Bengaluru District, Karnataka State, India.

Bangalore
KARNATAKA
560105
India 
Phone    
Fax    
Email  ramesh.mavathur@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Harichandra B P  
Designation  Researcj Scholar 
Affiliation  S-VYASA, Bengaluru 
Address  Swami Vivekananda Yoga Anusandhana Samsthanam, No.19, Eknath Bhavan, Gavipuram Circle,Kempe Gowda Nagar, Bengaluru, Karnataka, 560019, India
Swami Vivekananda Yoga Anusandhana Samsthanam, No.19, Eknath Bhavan, Gavipuram Circle,Kempe Gowda Nagar, Bengaluru, Karnataka, 560019, India
Bangalore
KARNATAKA
560019
India 
Phone    
Fax    
Email  harisnehadaana@gmail.com  
 
Source of Monetary or Material Support  
Self financed by researcher. However materials support is provided by Primary Sponsor. 
 
Primary Sponsor  
Name  H R Nagendra 
Address  Chancellor, Swami Vivekananda Yoga Anusandhana Samsthanam, No.19, Eknath Bhavan, Gavipuram Circle,Kempe Gowda Nagar, Bengaluru 
Type of Sponsor  Other [Research Center] 
 
Details of Secondary Sponsor  
Name  Address 
Harichandra B P  Swami Vivekananda Yoga Anusandhana Samsthanam, No.19, Eknath Bhavan, Gavipuram Circle, Kempe Gowda Nagar, Bengaluru  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
M N Ramesh  Snehadaan  Ambedkar Layout, Sarjapur Road, Carmelaram Post, Bengaluru
Bangalore
KARNATAKA 
9611161845

ramesh.mavathur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SVYASA Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  HIV positives,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  Pure control group 
Intervention  Yoga group  Basic Asanas and Pranayama (1 hour) + Yogic games (1 Hour). 5 days a week - Monday-Friday, 4 months 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  19.00 Year(s)
Gender  Both 
Details  Subjects with documented HIV+ status with CD4+ T-cell count > 200 cells per μl of blood
Able to read, write, understand English
Both of those on regular treatment like the ART or other treatment, or not on any treatment
 
 
ExclusionCriteria 
Details  Subjects with co morbid psychiatric illnesses
Subjects with other major co morbid illness viz., Fungal Infection in the last 1 month, cancer, Tuberculosis
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Immune parameters, viz., CD3+, CD4+, CD45+ cell count as available from routine checkup records.
Quality of life
Cognitive functions 
Pre - Post 2 time points 
 
Secondary Outcome  
Outcome  TimePoints 
General health indicator viz., BMI  Pre - Post 2 time points 
 
Target Sample Size   Total Sample Size="73"
Sample Size from India="73" 
Final Enrollment numbers achieved (Total)= "73"
Final Enrollment numbers achieved (India)="73" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/11/2013 
Date of Study Completion (India) 06/04/2014 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The purpose of this study was to evaluate the effectiveness of yoga intervention program on cognitive function, immune parameters and QOL of HIV positive individuals.  The analysis of the results is in progress.   
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