| CTRI Number |
CTRI/2025/07/091109 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Gayatri Mahamantra Chant on Mental Health of Women Prisoners |
|
Scientific Title of Study
|
Effect of Gayatri Mahamantra Chant on Depression, Anxiety, Stress and Mental Health of Women Prisoners: A Randomized Control 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 Sandeep Singh |
| Designation |
Assistant Professor |
| Affiliation |
University of Patanjali |
| Address |
Department of yoga science, University of Patanjali, Haridwar
Hardwar
UTTARANCHAL
249179
India |
| Phone |
8946870057 |
| Fax |
|
| Email |
drsandeep@uop.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Singh |
| Designation |
Assistant Professor |
| Affiliation |
University of Patanjali |
| Address |
Department of yoga science, University of Patanjali, Haridwar
Hardwar
UTTARANCHAL
249179
India |
| Phone |
8946870057 |
| Fax |
|
| Email |
drsandeep@uop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Singh |
| Designation |
Assistant Professor |
| Affiliation |
University of Patanjali |
| Address |
Department of yoga science, University of Patanjali, Haridwar
Hardwar
UTTARANCHAL
249179
India |
| Phone |
8946870057 |
| Fax |
|
| Email |
drsandeep@uop.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of yoga science, University of Patanjali,Haridwar Uttarakhand 249405 |
|
|
Primary Sponsor
|
| Name |
University Grant Commission |
| Address |
First floor,NSIC-MDBP Building Okhla Industrial Estate, Nrw Delhi, 110020 |
| Type of Sponsor |
Other [Government Funding Agency] |
|
|
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 |
| Geeta Kukreti |
District jail Haridwar |
District Jail Haridwar Women ward 2nd, SIDCUL Haridwar, Uttarakhand, 249403
Hardwar
UTTARANCHAL |
9634804487
drgeetabarthwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, University of Patanjali |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F439||Reaction to severe stress, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Yoga Intervention |
3 Months 6 days/week yoga with Gayatri Mantra Chanting intervention |
| Comparator Agent |
Yoga Intervention ((Yogic Sukshma Vyayamsa)) |
Participanta of control group will be advised to take 60 Minuts Yogic Sukshma Vyayama without Gayatri Mantra for 6 days/week in 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
They all are female
Age between 18 to 60
Subject are suffering from mental disorder
Willingly take part in the intervention
Who fill the Consent Form
|
|
| ExclusionCriteria |
| Details |
Male are excluded
Age below 60 and above 18
Women with certain medical condition (E.g. untreated cardio vesicular diseases, active cancer etc.).
Who are not suffering any mental health issues
Who are not fill the consent form and not interested in the intervention.
Pregnant and breast feeding ladies are excluded
Drugs addicted persons.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| depression, anxiety, stress and mental health |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
01/08/2025 |
| 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="3"
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
|
The World Prison Brief (2016) estimates that there are 10.35 million prisoners worldwide. Among them, the overall female population ranges from 21.2% to 0.7% (ICPS, 2016). The National Crime Records Bureau, Ministry of Home Affairs, Government of India, published the annual report “Prison Statistics India” for the year 2015. It reports that there were 1401 prisons in the nation in 2015, up from 1393 in 2010 (NCRB, 2015). This Indicates an increase in the number of imprisoned. The report also indicated that over the past ten years, the number of prisoners, both male and female, has climbed from 3,44,382 to 4,01,789 (95.7%) and from 13,986 to 17,834 (4.3%). In India, the number of prisoners has increased by 28% for women and 17% for males. The dependent variables of research are depression, anxiety, stress and mental health of women prisoners. The research includes 104 participants i.e. 52 participants in experimental group and 52 participants in control group. For data collection and making our results reliable, we chose three scales, which are beneficial in depression, anxiety, and stress. DASS-21 (Depression, Anxiety, and Stress Scale-21), Neuroticism Scale, World Health Organization Quality of Life questionnaire (WHOQOL-BREF), Trauma Symptom Checklist-40 are the instrument for research |