PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Thu, 30 Sep 2021 08:17:33 GMT)

CTRI Number CTRI/2019/05/019390 [Registered on: 27/05/2019] - Trial Registered Prospectively Last Modified On 27/05/2019 Post Graduate Thesis No Type of Trial Interventional Type of Study & Naturopathy Study Design Randomized, Parallel Group Trial Public Title of Study Yoga for visceral fat reduction in centrally obese Scientific Title of Effect of yoga on visceral fat in centrally obese adults using MRI: a RCT Study Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Shirley Telles Trial Coordinator (multi-center study) Designation Director Affiliation Patanjali Research Foundation Address Department of yoga research, Patanjali Research Foundation, IInd floor, Patanjali Yogpeeth Phase 1 249405 Department of yoga research, Patanjali Research Foundation, IInd floor, Patanjali Yogpeeth Phase 1 Haridwar-249405 UTTARANCHAL 249405 Hardwar UTTARANCHAL 249405 India Phone 01334-240008 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Shirley Telles Query) Designation Director Affiliation Patanjali Research Foundation Address Department of yoga research, Patanjali Research Foundation, IInd floor, Patanjali Yogpeeth Phase 1 Haridwar UTTARANCHAL 249405 India Department of yoga research, Patanjali Research Foundation, IInd floor, Patanjali Yogpeeth Phase 1 Haridwar UTTARANCHAL 249405 India Hardwar UTTARANCHAL 249405 India Phone 01334-240008 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Shirley Telles Designation Director Affiliation Patanjali Research Foundation Address Department of yoga research, Patanjali Research Foundation, IInd floor, Patanjali Yogpeeth Phase 1 Haridwar Hardwar UTTARANCHAL 249405 India Department of yoga research,

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Patanjali Research Foundation, IInd floor, Patanjali Yogpeeth Phase 1 Haridwar Hardwar UTTARANCHAL 249405 India Hardwar UTTARANCHAL 249405 India Phone 01334-240008 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Patanjali Research Foundation, Patanjali Yogpeeth Phase 1 Haridwar-249405, Primary Sponsor Primary Sponsor Details Name Patanjali Research Foundation Trust Address Patanjali Yogpeeth, Haridwar-249405 Type of Sponsor Other [Private Research Organization] Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Shirley Telles Patanjali Yogpeeth Department of yoga 01334240008 research, Patanjali Research Foundation, [email protected] IInd floor, Patanjali m Yogpeeth Phase 1 Haridwar Department of yoga research, Patanjali Research Foundation, IInd floor, Patanjali Yogpeeth Phase 1 Haridwar Hardwar UTTARANCHAL 249405 India Hardwar UTTARANCHAL Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 15/01/2019 No Committee of patanjali Research Foundation Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Endocrine, nutritional and metabolic diseases Intervention / Type Name Details Comparator Agent Intervention Yoga: Yoga breathing techniques, Yoga postures and guided relaxation for 75 minutes/day for 3 days a week for 12 weeks Comparator Agent Nutritional advice 45 minutes/week of nutritional

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advice for 12 weeks Inclusion Criteria Inclusion Criteria Age From 35.00 Year(s) Age To 50.00 Year(s) Gender Both Details The inclusion criteria will be (i) waist circumference ? 90 cm for male or ? 80 cm for female, (ii) BMI ? 25 kg/m2 (iii) ages between 35 and 50 years and (iv) willingness to take part in the study Exclusion Criteria Exclusion Criteria Details (i) Obesity secondary to hormonal imbalance, medication such as steroids or secondary to any other medical condition, (ii) any physical or psychological disability which would prevent the participants from taking part in the yoga program or following the nutritional advice, (iii) involvement in any other dietary or exercise program during the 12 months prior to, at the time of or during the study and (iv) any co-morbidities associated with obesity such as cardiovascular disease, type-2 diabetes mellitus or hypertension Method of Generating Stratified randomization Random Sequence Method of On-site computer system Concealment Blinding/Masking Outcome Assessor Blinded Primary Outcome Outcome Timepoints 1. Magnetic Resonance Imaging Before and after 12 weeks 2. Anthropometric Variables (BMI, WC, HC, MAC, SAD) 3. Body Composition 4. Lipid Profile 5. Fasting Blood Glucose 6. TNF Alpha 7. High Sensitivity C Reactive Protein 8. Blood pressure 9. 72 hr Diet Recall 10. Global Physical Activity Questionnaire Secondary Outcome Outcome Timepoints 1. Quality of life Before and after 12 weeks

Target Sample Size Total Sample Size=50 Sample Size from India=50 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 04/06/2019 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details NIL

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Brief Summary The study is planned to see whether 12 weeks of yoga (75 minutes/day for 3 days/week) can reduce the visceral fat based on the magnetic resonance imaging and other relevant measures.

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