| CTRI Number |
CTRI/2025/08/092825 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Integrated yoga therapy for the management of obesity |
|
Scientific Title of Study
|
Effect of Yoga on Physiological and Psychological Parameters Related to Obese Condition and the Wellbeing of Participants Affected by Obesity |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jinal Mokariya |
| Designation |
MSc student |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Swami Vivekananda Yoga Anusandhana Samsthana
Vivekananda Road
Division of Yoga & Life science
Research Department
Kallabalu(Post)
Jigani
Bengaluru
Bangalore Rural
KARNATAKA
560105
India |
| Phone |
9325939889 |
| Fax |
|
| Email |
jinalm627@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Nair |
| Designation |
Asst. Professor |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Swami Vivekananda Yoga Anusandhana Samsthana
Division of Yoga & Life science
Anvesana Research Labs
Vivekananda Road
Kallabalu(Post)
Jigani
Bengaluru
Bangalore Rural
KARNATAKA
560105
India |
| Phone |
09632164777 |
| Fax |
|
| Email |
rajeshnair@svyasa.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Nair |
| Designation |
Asst. Professor |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Swami Vivekananda Yoga Anusandhana Samsthana
Division of Yoga & Life science
Anvesana Research Labs
Vivekananda Road
Kallabalu(Post)
Jigani
Bengaluru
KARNATAKA
560105
India |
| Phone |
09632164777 |
| Fax |
|
| Email |
rajeshnair@svyasa.edu.in |
|
|
Source of Monetary or Material Support
|
| Arogyadhama - Holistic Research Health Home
Prashati Kutiram
Vivekananda Road
Kallabalu(Post)
Jigani
Bengaluru - 560105 |
|
|
Primary Sponsor
|
| Name |
Arogyadhama - Holistic Research Health Home |
| Address |
Prashati Kutiram
Vivekananda Road
Kallabalu(Post)
Jigani
Bengaluru - 560105
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Amit Singh |
Arogyadhama - Holistic Research Health Home |
Room No. H,
Obesity-Section,
Dept. of Physiology,
Division of Yoga & Life Science.
Prashati Kutiram
Vivekananda Road
Kallabalu(Post)
Jigani
Bengaluru - 560105
Bangalore Rural
KARNATAKA |
08022639963
arogyadhama@svyasa.edu.in |
|
|
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 |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated Approach of Yoga Therapy |
Asana, Pranayama and meditative sessions - multiple session in a day, all days for 2 weeks. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects, both male and females, identified with obesity.
Age. 25-60.
Diagnosed with obesity (BMI greater or equal to 25 kg/mĀ²) |
|
| ExclusionCriteria |
| Details |
Subjects having any other severe health issues that interfere with the yoga practices. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Body Mass Index. |
Baseline and at the end of the 2nd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Blood pressure
Sleep Quality
Depression
Anxiety
Stress |
Baseline & at the end of the 2nd week |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
22/09/2025 |
| 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="0"
Days="14" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [jinalm627@gmail.com].
- For how long will this data be available start date provided 01-11-2025 and end date provided 31-10-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Obesity becoming a serious global health issue. If is also leading to many other lifestyle related issues like diabetes, cancer, cardiovascular mortality. Lifestyle modification techniques like yoga are found to be useful in the management of lifestyle disorders. In this context, this study is examining how an integrated yoga therapy can be effective in people affected with obesity disorder. This study was aimed at observing the effect of an integrated approach of yoga therapy on the psychological and psychological parameters related to obese condition in a clinical setup.
|