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
|
|
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. |