| CTRI Number |
CTRI/2026/01/100239 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of yoga on the mental health of women affected by conflict |
|
Scientific Title of Study
|
Yoga for Enhancing the Mental Health of Women Affected by Conflict: A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Soubhagyalaxmi Mohanty |
| Designation |
Associate Professor |
| Affiliation |
S-VYASA University |
| Address |
S-VYASA, Deemed to be University, Division of Yoga and Humanities, Jigani, Bengaluru, India
Bangalore Rural KARNATAKA 560105 India |
| Phone |
9483852383 |
| Fax |
|
| Email |
soubhagyalaxmi.mohanthy@svyasa.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Soubhagyalaxmi Mohanty |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
S-VYASA, Deemed to be University, Department of Yoga and Humanities, Jigani, Bengaluru, India
Bangalore Rural KARNATAKA 560105 India |
| Phone |
9483852383 |
| Fax |
|
| Email |
thongamchanchan17@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Soubhagyalaxmi Mohanty |
| Designation |
Associate Professor |
| Affiliation |
S-VYASA University |
| Address |
S-VYASA, Deemed to be University, Division of Yoga and Humanities, Jigani, Bengaluru, India
Bangalore Rural KARNATAKA 560105 India |
| Phone |
9483852383 |
| Fax |
|
| Email |
soubhagyalaxmi.mohanthy@svyasa.edu.in |
|
|
Source of Monetary or Material Support
|
| Swami Vivekananda Yoga Anusandhana Samsthana, Bengaluru |
|
|
Primary Sponsor
|
| Name |
SVYASA UNIVERSITY |
| Address |
S-VYASA, Deemed to be University, Division of Yoga and Humanities, Jigani, Bengaluru, 560105, India |
| Type of Sponsor |
Research institution |
|
|
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 |
| Lady Thongam |
Mekola Relief Camp |
Mekola Gulab Higher Secondary School, Mekola, Imphal West, Manipur Imphal West MANIPUR |
9862186498
thongamchanchan17@gmail.com |
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects undergone Manipur ethnic conflicts |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
No intervention provided. |
| Intervention |
Yoga |
Validated Yoga module including Asana, Pranayama, Relaxation. Duration- 1 month, Frequency-6 days/week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PHASE 1:
1. 18-60 years male and female in the relief camp.
2. Who can understand the Manipuri language.
PHASE 2:
1. Female willing to take part in the study.
2. Currently residing in relief camps due to ethnic conflict in Manipur
3. Who can understand the Manipuri language. |
|
| ExclusionCriteria |
| Details |
PHASE 1:
1. Known severe psychological problems.
2. Who denied providing a consent form.
PHASE 2:
1. No physical impairment that will affect the yoga practice.
2. Who denied providing a consent form. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Stress, anxiety, and depression
PTSD, Uncertainty, Emotion/mood, lung function, Sleep, Hunger |
At baseline, Post test at 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="134" Sample Size from India="134"
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)
|
02/02/2026 |
| 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="9" Days="0" |
|
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 - NO
|
|
Brief Summary
|
Women exposed to conflict often face severe traumatic experiences such as physical and sexual abuse, grief, and loss of loved ones. These events can lead to long-term physical and psychological harm, placing them at higher risk of anxiety, depression, stress, and other mental health problems. Although social support and cultural practices offer some relief, they have shown limited effectiveness in fully addressing these women’s needs. There remains a gap in comprehensive strategies to support their overall well-being. The current study aims to assess the mental well-being of women affected by ethnic conflicts and explore yoga as a potential intervention to improve their mental health. |