| CTRI Number |
CTRI/2025/06/089241 [Registered on: 20/06/2025] Trial Registered Prospectively |
| Last Modified On: |
18/06/2025 |
| 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
|
Role of Yoga in women with anxiety and depression |
|
Scientific Title of Study
|
Impact of Yoga on Improving Mental Health Among Women in a Military Setting in Ernakulam: An Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jishnu Sathees Lalu |
| Designation |
Surgeon Commander |
| Affiliation |
Indian Navy |
| Address |
Station Health Organisation
Department of Public Health
c/o O/o Command Medical Officer
Southern Naval Command
Naval Base, Kochi
Ernakulam KERALA 682004 India |
| Phone |
9633246782 |
| Fax |
|
| Email |
jishnudivya@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Jishnu Sathees Lalu |
| Designation |
Surgeon Commander |
| Affiliation |
Indian Navy |
| Address |
Station Health Organisation
Department of Public Health
c/o O/o Command Medical Officer
Southern Naval Command
Naval Base, Kochi
Ernakulam KERALA 682004 India |
| Phone |
9633246782 |
| Fax |
|
| Email |
jishnudivya@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Jishnu Sathees Lalu |
| Designation |
Surgeon Commander |
| Affiliation |
Indian Navy |
| Address |
Station Health Organisation
Department of Public Health
c/o O/o Command Medical Officer
Southern Naval Command
Naval Base, Kochi
Ernakulam KERALA 682004 India |
| Phone |
9633246782 |
| Fax |
|
| Email |
jishnudivya@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Station Health Organisation
Department of Public Health
c/o O/o Command Medical Officer
Southern Naval Command
Naval Base, Kochi, Kerala 682004 |
|
|
Primary Sponsor
|
| Name |
Indian Navy |
| Address |
Station Health Organisation
Department of Public Health
c/o O/o Command Medical Officer
Southern Naval Command
Naval Base, Kochi, Kerala 682004 |
| Type of Sponsor |
Other [Unit under Indian Navy] |
|
|
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 |
| Surg Cdr Jishnu Sathees Lalu |
Station Health Organisation |
Station Health Organisation
Department of Public Health
c/o O/o Command Medical Officer
Southern Naval Command
Naval Base, Kochi Ernakulam KERALA |
9633246782
jishnudivya@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE OF NAVAL MEDICINE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F419||Anxiety disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Treatment |
As advised by the Psychiatrist |
| Intervention |
Yoga postures |
The following yoga postures shall be used as intervention for a duration of 3 months and outcome measures after one month and 3 momths:-Soorya namaskar, Trikonasana, Vrikshasana, Parivrutha janu sirasana, Vakrasana, Uttanapadasana, Sethu bandasana, Sasankasana, Corpse pose, Nadishudhi pranayama, Bhramari pranayama |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All women in the reproductive age group |
|
| ExclusionCriteria |
| Details |
Women in the following category shall be excluded :-
Severe comorbidities
Pregnant women
Breast feeding mothers |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| stabilization of anxiety and stress |
at baseline, after 4 weeks and after 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="122" Sample Size from India="122"
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)
|
01/07/2025 |
| 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="1" Months="0" 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
|
Yoga is an ancient mind-body practice that combines physical postures, breathing techniques, and meditation. It is recognized for its ability to improve physical health, and emerging research highlights its efficacy in enhancing mental health by promoting relaxation, reducing stress, and fostering mindfulness. Several studies underscore the potential of yoga as a tool for addressing mental health challenges faced by women. A Study demonstrated that 12 sessions of regular Hatha yoga significantly reduced stress, anxiety, and depression among women. It highlighted yoga’s ability to decrease sympathetic nervous system activity, which is linked to stress reduction. Meta-analysis that compared yoga to other physical activities and found a significant increase in psychological well-being in favor of yoga. Traditional therapeutic approaches, such as medication and counselling, while effective, may not address all dimensions of mental well-being. Increasing evidence suggests that integrative mind-body practices like yoga can play a complementary role in enhancing mental health outcomes. To address the gaps in current gap in knowledge an experimental study titled "Impact of Yoga on Improving Mental Health Among Women in a Military Setting in Ernakulam: An Experimental Study" is proposed to be conducted to study the impact of yoga on mental health among women. This study will be conducted in a military setting in Kerala among women in reproductive age group. The study samples shall be screened in multiple phases. About 122 study samples shall be identified and randomly assigned to each group where one group will receive yoga interventions such as Soorya namaskar, Trikonasana, Vrikshasana, Parivrutha janu sirasana, Vakrasana, Uttanapadasana, Sethu bandasana, Sasankasana, Corpse pose, Nadishudhi pranayama, Bhramari pranayama and the control group shall be given standard treatment as advised by the psychiatrist. The intervention shall be followed up for 3 months using Perceived Stress Scale and Hospital Anxiety and Depression Scale. |