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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 


 
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