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CTRI Number  CTRI/2024/02/062804 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 17/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of Yoga on Depression  
Scientific Title of Study   Effectiveness of Yoga Intervention on Patients with Mild and Moderate Depression - A Randomized Controlled Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
IEC-NI/23/AUG/89/88  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Mrs. Ayisha Siddeequa M.A. 
Designation  Ph D Research Scholar in Clinical Psychology, Department of Psychiatry 
Affiliation  Sri Ramachandra Institute of Higher Education and Research (DU) 
Address  No:1, Ramachandra Nagar, Porur, Chennai
-
Chennai
TAMIL NADU
600116
India 
Phone  8124612463  
Fax    
Email  ayishasiddeequama.sriher@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suvarna Jyoti Kantipudi  
Designation  Associate Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  G Block, Department of Psychiatry OP Services, Sri Ramachandra Medical College and Research Institute.

Chennai
TAMIL NADU
600116
India 
Phone  9047492143  
Fax    
Email  suvarna@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Suvarna Jyoti Kantipudi  
Designation  Associate Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  G Block, Department of Psychiatry - OP Services, Sri Ramchandra Medical College and Research Institute.

Chennai
TAMIL NADU
600116
India 
Phone  9047492143  
Fax    
Email  suvarna@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute of Higher Education and Research [Deemed University] 
 
Primary Sponsor  
Name  Ayisha Siddeequa M A 
Address  1196 Anna Nagar West End Colony Street TS Krishna Colony Chennai 600050 
Type of Sponsor  Other [Self Funding ] 
 
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 
Ayisha Siddeequa MA  Sri Ramachandra Institute of higher Education and Research  G Block, Department of Psychiatry, Link Room Sri Ramchandra Institute of Higher Education and Research (DU). No.1 Ramachandra Nagar, Porur Chennai 600 116
Chennai
TAMIL NADU 
8124612463
-
ayishasiddeequama.sriher@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, (2) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Yoga Intervention   Yoga Intervention For Mild and Moderate Depression, Developed and Validated by Dhamodhini et. al from SRIHER. The participants in the intervention group will be asked to attend the sessions for 12 weeks (each training session lasting for about an hour)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patients with mild and moderate level of depression ranging between the age group of 18 -45 years will be recruited for the study.
 
 
ExclusionCriteria 
Details  The depressive patients with intellectual disability, substance abuse disorder (except nicotine and caffeine), dementia, epilepsy or cerebrovascular accidents, history of psychosis or bipolar disorder, patients with suicidal risks or catatonia will be excluded from the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The physiological, psychological, and neuropsychological parameters of the mild and moderate depressive patients ranging between the age group of 18 - 45 years will be measured [pre- test & post test].  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
The participants in the intervention group will receive intervention for 12 weeks.
After the post-test, a follow-up for 6 months will be made on the subsamples of the total
samples to measure the long–term effectiveness of the yoga intervention through an in-depth
interview to obtain insights to understand the holistic perspective of the participants and
barriers and facilitators in practicing yoga as a coping strategy. 
Intervention: 12 weeks
Follow-up [ after post-test]:6 months
InDepth Interview: 12 weeks 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 1 
Date of First Enrollment (India)   26/02/2024 
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="6"
Days="15" 
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  
After screening, a sample size of 90 participants with mild and moderate levels of depression attending the outpatient service of the Psychiatry Department of Sri Ramachandra Institute of Medical College and Research Institute will be recruited with informed consent before beginning the study and will be equally divided into two groups namely; the control group (45) and the interventional group (45). As the meta-analysis of studies of yoga for depression suggests Cohen’s d within groups was 0.45 for aerobic exercise and 0.38 for yoga training. A power analysis in G power assuming two independent means indicated 38 people per arm are necessary to have 80% power to detect this magnitude of a difference between samples. The sample size has been statistically calculated as (n=90). Though 38 people per arm are needed, however, we are recruiting 45 people per arm by expecting a 20% of dropout rate. Therefore, depressive patients (n=90), with mild and moderate levels of depression ranging between the age group of 18 - 45 years will be recruited for the study, excluding the depressive patients with intellectual disability, substance abuse disorder (except nicotine and caffeine), dementia, epilepsy, or cerebrovascular accidents, history of psychosis or bipolar disorder, and patients with suicidal risks or catatonia. The physiological, psychological, and neuropsychological parameters will be measured and studied with their other psycho-socio-demographic details on both groups. The participants in the control group will be taking conventional treatment and the participants in the interventional group will be taking the conventional treatment&n 
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