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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Tue, 28 Sep 2021 05:53:33 GMT) CTRI Number CTRI/2020/05/025051 [Registered on: 06/05/2020] - Trial Registered Prospectively Last Modified On 22/09/2020 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Yoga & Naturopathy Study Design Randomized, Parallel Group Trial Public Title of Study Clinical trial to study the efficacy of Transcendental Meditation for lowering blood pressure Scientific Title of Efficacy of Transcendental Meditation for reducing blood pressure among patients with elevated or Study stage-I hypertension – A Randomized Controlled Trial Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Vartika Saxena Trial Coordinator (multi-center study) Designation HOD AYUSH, Professor CFM Affiliation AIIMS, Rishikesh Address Room no. 015306, Floor 5, Department of Community and Family Medicine, Medical College building, AIIMS Rishikesh, Virbhadra Road, Rishikesh Dehradun UTTARANCHAL 249203 India Phone Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Mr Vikas Upadhyay Query) Designation MA, JRF, PhD Scholar Affiliation AIIMS Rishikesh Address Building no 30, Department of AYUSH, AIIMS Rishikesh, Virbhadra Road,Rishikesh Dehradun UTTARANCHAL 249203 India Phone 9716277264 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Mr Vikas Upadhyay Designation MA, JRF, PhD Scholar Affiliation AIIMS Rishikesh Address Building no 30, Department of AYUSH, AIIMS Rishikesh, Virbhadra Road,Rishikesh Dehradun UTTARANCHAL 249203 India page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Phone 9716277264 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > AIIMS Rishikesh Virbhadra Road, Rishikesh, Uttarakhand-249203 Primary Sponsor Primary Sponsor Details Name AIIMS Rishikesh Address AIIMS Rishikesh Virbhadra Road, Rishikesh, Uttarakhand-249203 Type of Sponsor Research institution and hospital 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 Vartika Saxena AIIMS Rishikesh Room no. 015306, 9716277264 Floor 5, Department of Community and Family [email protected] Medicine, Medical College building, AIIMS Rishikesh, Virbhadra Road, Rishikesh, Uttarakhand-249203 Dehradun UTTARANCHAL Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? AIIMS Rishikesh Approved 08/02/2020 No Institutional Ethics Committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Essential (primary) hypertension Intervention / Type Name Details Comparator Agent Intervention Transcendental Meditation Transcendental Meditation (TM) was introduced by Maharishi Mahesh Yogi, a mantra meditation technique where consciousness is directed towards repetition of a word, or a phrase as an object of focus. Duration of the meditation is 20 minutes twice daily (morning and evening) while seated comfortably with eyes closed. Comparator Agent Counselling on lifestyle These included specific modification guidelines for weight reduction, adopt DASH eating plan, reduction of dietary salt, physical activity and stopping smoking and moderation of page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in alcohol consumption based on the lifestyle modification recommendations for reducing hypertension mentioned in the Current Medical Diagnosis and Treatment. Inclusion Criteria Inclusion Criteria Age From 20.00 Year(s) Age To 60.00 Year(s) Gender Both Details 1. Participants having elevated or stage I category of blood pressure with 10 year ASCVD risk < 10% (Not requiring pharmacotherapy, according to AHA guidelines 2019)<br/> 2. Participants are willing to participate in the study for the next 6 months<br/> Exclusion Criteria Exclusion Criteria Details Participants having any of following condition will be excluded: 1. History of Hypertension stage-II & hypertensive crisis 2. Taking Anti-Hypertensive medications 3. Diagnosed cases of Cardiovascular disease, Diabetes mellitus, Chronic kidney disease, Ischemic heart disease 4. Psychiatric disorder (psychoses, substance abuse, dementia) 5. Pregnant women 6. any other life-threatening medical illness Method of Generating Computer generated randomization Random Sequence Method of Sequentially numbered, sealed, opaque envelopes Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Reduction in blood pressure Baseline and monthly till first 3 months then at 6th month Secondary Outcome Outcome Timepoints 1. Improvement in selective attention Baseline and monthly till first 3 months then at 2. Improvement in anxiety 6th month 3. Increase in happiness 4. Reduction in stress 5. Change in cortisol level Target Sample Size Total Sample Size=182 Sample Size from India=182 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 11/05/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=2 Trial Months=6 Days=0 Recruitment Status of Other (Terminated) Trial (Global) Recruitment Status of Other (Terminated) Trial (India) page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Publication Details Nil Brief Summary Trial has been completely modified. page 4 / 4 Powered by TCPDF (www.tcpdf.org).
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