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CTRI Number  CTRI/2012/09/003017 [Registered on: 25/09/2012] Trial Registered Retrospectively
Last Modified On: 03/08/2013
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of yoga therapy on cardiac autonomic functions and oxidative stress in subjects at risk of high blood pressure 
Scientific Title of Study   Effect of yoga therapy on cardiac autonomic functions and oxidative stress in prehypertension subjects: a randomized controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ramkumar T 
Designation  PhD scholar, DST INSPIRE fellow 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) 
Address  Department of Physiology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvanthri nagar, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9843666896  
Fax    
Email  ramkumar2211@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr A K das 
Designation  Medical Superintendent and Senior Professor of Medicine 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) 
Address  Medical Superintendent Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvanthri nagar, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9789457887  
Fax    
Email  ashokdas82@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr A K das 
Designation  Medical Superintendent and Senior Professor of Medicine 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) 
Address  Medical Superintendent Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvanthri nagar, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9789457887  
Fax    
Email  ashokdas82@gmail.com  
 
Source of Monetary or Material Support  
JIPMER 
 
Primary Sponsor  
Name  Intramural fund JIPMER Pondicherry 
Address  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry-605006 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
DST INSPIRE fellowship  Department of science & technology, Government of India, New Delhi 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ramkumar Thiyagarajan  Autonomic Lab, Department of Physiology  79A, Autonomic lab, Department of Physiology, JIPMER, Dhanvantri nagar Pondicherry-605006
Pondicherry
PONDICHERRY 		 9843666896

ramkumar2211@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Human Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Prehypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lifestyle modification (LSM)  Details: standard LSM as recommended by JNC7, 2003 includes, 1. Weight reduction 2. Salt restriction 3. DASH eating plan 4. Regular exercise 5. Reduction of alcohol 
Intervention  Yoga therapy  Yoga therapy includes, a.Yogic counseling for initial few classes b.Preparatory practices c.Body movements coordinated with breath (Asans) d.Breathing practices (Pranayams) e.Relaxation techniques coordinated with breath (Shavasan) each session lasts 40 minutes for 3 days a week for 12 week in addition to standard LSM as recommended by JNC7, 2003 includes, 1. Weight reduction 2. Salt restriction 3. DASH eating plan 4. Regular exercise 5. Reduction of alcohol 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  SBP : 120 – 139 mmHg and / or DBP : 80 – 89 mmHg
Age : 20 – 60 years
Gender : both
Willing to practice yoga
Written informed consent 
 
ExclusionCriteria 
Details  Diabetes mellitus
Cardiovascular disease
Autonomic failure
Renal insufficiency
Patients on drug treatment for prehypertension
Any physical condition hindering the performance of yoga
Subjects already practicing yoga
Sports persons, athletes & body builders
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The addition of yoga therapy to standard lifestyle modification approaches confers additional benefits in terms of:
1. Lowering resting blood pressure
2. Increasing overall short-term HRV
3. Indices of oxidative stress
 		 After 12 weeks of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in,
1. Quality of life
2. Mental/physical well-being
3. Cardiovascular risk for next 10 years
 		 12 weeks after enrollment of the study for each person 
 
Target Sample Size   Total Sample Size="204"
Sample Size from India="204" 
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)   30/08/2010 
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="2"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is a randomized controlled study, the subjects with prehypertension (systolic BP 120-139 mmHg and/or diastolic BP 80-89 mmHg) will be screened in various OPDs & staffs of JIPMER, government officials and also through various screening camps in Pondicherry. After the baseline recording they will be randomized to either lifestyle modification (LSM) group or LSM + yoga group for 12 weeks. The expected primary outcome will be improved resting blood pressure, cardiovagal modulation and oxidative stress parameters. The secondary outcomes will be improved quality of life, physical and mental well-being and cardiovascular risk for next ten years. 
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