FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/092212 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 08/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Physiotherapy (Not Including YOGA)
Behavioral 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Study to analyse the effectiveness of Yoga in patients with Pulmonary hypertension 
Scientific Title of Study   Yoga in Pulmonary hypertension: Open label, multi centric, randomized controlled clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prashant Bobhate 
Designation  Consultant Pediatric cardiologist and In charge Pulmonary hypertension clinic 
Affiliation  Kokilaben Dhirubai Ambani Hospital, Mumbai  
Address  2nd Floor, Children Heart clinic,Kokilaben Dhirubai Ambani Hospital, Mumbai, Maharashtra, India

Mumbai
MAHARASHTRA
400053
India 
Phone  8080826898  
Fax    
Email  prashantbobhate@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ambalam M Chandrasekaran 
Designation  Head, Centre for Yoga in Public Health Research 
Affiliation  Centre for Chronic Disease Control, Department of Clinical Trials,  
Address  Health system unit, C1/52, Second floor, Safdarjung Development Area, New Delhi

New Delhi
DELHI
110016
India 
Phone  01141618456  
Fax    
Email  chandrasekaran@ccdcindia.org  
 
Details of Contact Person
Public Query  
Name  Dr Ambalam M Chandrasekaran 
Designation  Head, Centre for Yoga in Public Health Research 
Affiliation  Centre for Chronic Disease Control, Department of Clinical Trials,  
Address  Health System Unit, C1/52, Second floor, Safdarjung Development Area, New Delhi

New Delhi
DELHI
110016
India 
Phone  01141618456  
Fax    
Email  chandrasekaran@ccdcindia.org  
 
Source of Monetary or Material Support  
Central Council for Research in Yoga and Naturopathy, 61-65, Institutional Area, Sewa Marg, Pocket D 1A, Janakpuri, New Delhi, Delhi 110058 
 
Primary Sponsor  
Name  Central Council for Research in Yoga and Naturopathy  
Address  61 to 65, D block, Janakpuri Institutional Area, New Delhi, 110058 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bhanu Duggal  All India Institute of Medical Sciences   Department of Cardiology
Dehradun
UTTARANCHAL 		 9869418148

bhanu.cardio@aiimsrishikesh.edu.in 
Dr Ramakrishnan   All India Institute of Medical Sciences   Department of cardiology
New Delhi
DELHI 		 9818186179

ramaaiims@gmail.com 
Dr Prashant Bhopate  Kokilaben Dhirubai Ambani Hospital  2nd floor, Children Heart Clinic, Kokilaben Dhirubhai Ambani Hospital
Mumbai
MAHARASHTRA 		 8080826898

prashantbobhate@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional ethics committee, AIIMS Delhi  Approved 
Institutional Ethics committee, AIIMS Rishikesh  Approved 
Institutional Ethics committee, Kokilaben Dhirubhai Ambani hospital and medical research institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I272||Other secondary pulmonary hypertension, (2) ICD-10 Condition: I278||Other specified pulmonary heart diseases, (3) ICD-10 Condition: I270||Primary pulmonary hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Enhanced standard care  A health education booklet and three telephonic sessions to teach patients of healthy living or lifestyle recommendations scheduled over three months  
Intervention  Home based exercise programme  Physiotherapist delivered home based exercise comprising of exercise involving warm up exercise, exercise for major muscle groups and cooling down. Participants are expected to practice minutes everyday and physiotherapist will have follow-up telephonic calls  
Intervention  Yoga based cardiac rehabilitation programme (Yoga-CaRe)  Yoga based cardiac rehabilitation programme comprising of yogic practices such as asana, pranayama meditation and lifestyle practices delivered by a Yoga and Naturopathy doctor over 20 supervised sessions in the first three months followed by home practice and reinforcement sessions as and when required.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with pulmonary hypertension, defined as peak tricuspid regurgitation velocity of more than 3.5meters per second by 2 dimensional echocardiogram.
Stable on medications for 3 months prior to enrollment
WHO functional class II and III
6MWD less than 440m 
 
ExclusionCriteria 
Details  Patients who choose to get recruited in the cardiopulmonary rehabilitation program.
WHO functional class 1 and 4.
Recent episode of syncope within less than 1 month.
Recent acute coronary event within less than 3 months
Evidence of left heart failure.
Pregnant or planning to get pregnant in the study period.
Uncontrolled arrhythmia.
Unstable angina.
Practicing yoga regularly more or enrolled in cardiac rehabilitation program.
Participating in any other clinical trial
Significant neuromuscular complications inhibiting participation in the trial.
Significant hepatic or renal dysfunction Enzymes more than 2 times normal or Serum creatinine more than 2 times.

 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
The six-minute walk distance obtained from the six-minute walk test  At baseline, three months and six months 
 
Secondary Outcome  
Outcome  TimePoints 
WHO functional class  Baseline, three months and six months  
Quality of life assessment using emPHasis 10 questionnaire   baseline, three months and six months 
Cardiopulmonary exercise test  Baseline and six months  
Echocardiogram  At baseline, three months and six months 
N terminal pro brain natriuretic peptide   Baseline and six months  
Interleukin 6   At baseline and six months  
high sensitivity CRP   At baseline and six months  
Heartrate variability  At baseline and six months 
 
Target Sample Size   Total Sample Size="246"
Sample Size from India="246" 
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 3 
Date of First Enrollment (India)   15/08/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [prashantbobhate@gmail.com].

  6. For how long will this data be available start date provided 01-02-2027 and end date provided 01-02-2047?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

This study aims to test if yoga can be a safe and effective form of cardiac rehabilitation for patients with pulmonary hypertension. Due to limited access to traditional rehabilitation programs in India, yoga offers a low-cost and culturally acceptable alternative.

Patients will be divided into three groups:

1) Control group: Receiving standard medical care, 

2) Intervention group1: Yoga based cardiac rehabilitation 

3) Intervention group 2:  Following a home-based rehabilitation program. 

The main outcome of the study is improvement in exercise capacity, which will be measured using the six-minute walk test.

Other important outcomes include:

Changes in quality of life, measured through a patient questionnaire

Changes in heart function, assessed by echocardiography

Levels of inflammation markers in the blood

Heart rate variability, to understand changes in the nervous system.

The study will help assess if yoga can be a practical and beneficial alternative to traditional cardiac rehabilitation for patients with pulmonary hypertension in India.

 
Close