| CTRI Number |
CTRI/2025/03/081645 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Yoga for People Living with HIV. |
|
Scientific Title of Study
|
Effectiveness of Yoga therapy as an adjunct on Mental health status, quality of life and
medication adherence among People Living with HIV on Antiretroviral therapy: A
Randomized Controlled Trial. |
| Trial Acronym |
ART-YOGA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gautam Sharma |
| Designation |
Professor-In Charge |
| Affiliation |
AIIMS New Delhi |
| Address |
Centre for Integrative Medicine and Research (CIMR), 7th floor Convergence Block, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9811388311 |
| Fax |
|
| Email |
drgautamsharma12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gautam Sharma |
| Designation |
Professor-In Charge |
| Affiliation |
AIIMS New Delhi |
| Address |
Centre for Integrative Medicine and Research (CIMR), 7th floor Convergence Block, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9811388311 |
| Fax |
|
| Email |
drgautamsharma12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gautam Sharma |
| Designation |
Professor-In Charge |
| Affiliation |
AIIMS New Delhi |
| Address |
Centre for Integrative Medicine and Research (CIMR), 7th floor Convergence Block, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9811388311 |
| Fax |
|
| Email |
drgautamsharma12@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar, New Delhi-29 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gautam Sharma |
Centre for integrative medicine and research (CIMR) and ART Clinic, AIIMS New Delhi |
All India Institute of Medical Sciences, Delhi
New Delhi
DELHI |
9811388311
drgautamsharma12@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group:
Moderate to intense walking (brisk walking) along with standard treatment |
The control group will be advised to continue the standard medical treatment for the same
duration, i.e. 12 months, including 30 minutes moderate intensity walking per day (brisk
walking). |
| Intervention |
Yoga Intervention |
The 12-week, 36-session Yoga program will be given by a trained and certified yoga therapist at C.I.M.R.
It is divided into two parts:
a) 12 sessions for 4 weeks having 60-minute individually supervised yoga sessions.
b) 24 sessions for the remaining 8 weeks are 60-minute online therapy sessions.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed with HIVRNA, and on stable Antiretroviral therapy
2. No contradictions to initiating a Yoga regime.
3. Karnofsky performance scale of more than 70 |
|
| ExclusionCriteria |
| Details |
1. Current or past history of hypertension, diabetes, heart failure,stroke and apparent
opportunistic infection.
2. Use of antihypertensive drugs and anti-depressant medication.
3. Use of Immunosuppressive or immunomodulatory medications other than ART
(within 6 months).
4. Pregnant and lactating women.
5. Known physical disability or mental disorder.
6. Practicing any form of yoga, meditation or exercise. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Psychological assessment -Hospital anxiety and depression scale (HADS) |
Baseline,3rd, 6th and 12th months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. WHO QoL-HIV BREF
2. SF-36 Questionnaire
3. Perceived Stress Scale
4.The AIDS Clinical Trials Group Adherence Questionnaire (ACTG-AQ) |
Baseline, 3rd, 6th and 12th months |
|
|
Target Sample Size
|
Total Sample Size="146"
Sample Size from India="146"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
People living with HIV (PLHIV) often experience major psychological challenges such as
anxiety, depression, and stress, which are worsened by the stigma, social isolation, and
chronic nature of the disease (HIV), impacting both their mental health, quality of life (QoL) and
medication adherence.While antiretroviral therapy (ART) effectively increases the lifespan of
people living with HIV (PLHIV) and controls viral replication, it does not directly focus on
the psychological burden or quality of life, emphasizing the need for holistic and
comprehensive interventions in addition to ART.Yoga has demonstrated benefits in improving
psychological well-being and quality of life in the HIV seronegative population.However,
there are several gaps in the current literature on yoga interventions for PLHIV.First, there is
significant heterogeneity in the forms of yoga (e.g., Hatha, Integrated, Sudarshan Kriya) and
durations (ranging from 6 days to 20 weeks)used in the existing studies, making it difficult to
determine which specific practices are most effective for improving psychological outcomes,
quality of life (QOL). Second, theseyoga-based studies have been pilot trials or conducted
with small sample sizes and short follow-up periods,resulting in inconsistent findings on
depression, anxiety, and quality of life. Furthermore, none of the previous studies
investigatedthe effect of yoga interventions on medication adherence in people living with
HIV.This is the first study aimed at assessing the effectiveness of yoga as an adjunct therapy
.
on the psychological outcomes, quality of life and medication adherence of people living with
HIV. |