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CTRI Number  CTRI/2023/05/052910 [Registered on: 19/05/2023] Trial Registered Prospectively
Last Modified On: 18/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of yoga vs usual care in Coronary Artery Disease Patients. 
Scientific Title of Study   A Randomized Control Trial to compare the effect of Yoga with usual care vs usual care in the patients of coronary artery disease. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neelam Dahiya 
Designation  Associate Professor 
Affiliation  PGIMER Chandigarh 
Address  Department of Cardiology PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9876386810  
Fax    
Email  drneelamdahiya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neelam Dahiya 
Designation  Associate Professor 
Affiliation  PGIMER Chandigarh 
Address  Department of Cardiology PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9876386810  
Fax    
Email  drneelamdahiya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Neelam Dahiya 
Designation  Associate Professor 
Affiliation  PGIMER Chandigarh 
Address  Department of Cardiology PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9876386810  
Fax    
Email  drneelamdahiya@gmail.com  
 
Source of Monetary or Material Support  
CCRYN(Collaborative Centre for Research in Yoga and Naturopathy) 
 
Primary Sponsor  
Name  Collaborative Centre for Research in Yoga and Naturopathy 
Address  61-65, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, 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 = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neelam Dahiya  Post Graduate Institute of Medical Education and Research, Chandigarh  Room no-3032,Department of Cardiology.
Chandigarh
CHANDIGARH 		 9876386810

drneelamdahiya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitonal Ethics Committe, PGIMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I252||Old myocardial infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  Control group also will be of CAD patients who will undergo Usual Care only. 
Intervention  Yoga  Yoga protocol has been made specially for CAD patients. Starting from sukshma vyama(joint movements) , proceeded with asanas and pranayama later at the end with shavasna.Intervention will be given for 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of 18 to 65 years who underwent PCI 2 -6 weeks prior to enrollment
2. Those who have LVEF of more than 40 %
3. Those who are not planned for revascularization during the study period
4. Those who have fair to good functional capacity
 
 
ExclusionCriteria 
Details  1. Patients who are not willing to participate will be excluded,
2. Those who refractory or class III angina.
3. Those who have refractory or uncontrolled hypertension
4. Those who have physical disability and pregnant women
5. Life threatening arrhythmia
6. Obese persons and patients on hormonal therapy will be excluded
7. Any other significant chronic illness.
8. Those who are under other CR program
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare outcome on BMI, Lipid Profile.
To compare LVEF in two groups.
To compare inflammatory markers in two groups.
To compare effect on psychological issues.
To investigate effect of genetic polymorphism on outcome
 		 First 3 months and followup for next 3 months. 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare changes in BMI and  Lipid Profile
2. To investigate the effect of genetic polymorphism
3. To compare effects on psychological issues. 		 1 and 2 will be measured at baseline and three months and 3rd will be assesses at baseline , 3 months and 6 months. 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   31/05/2023 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet published 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  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 [drneelam@gmail.com].

  6. For how long will this data be available start date provided 01-06-2026 and end date provided 31-07-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Background of the study:
 
Yoga has quickly risen to one of the most common complementary and alternative medicine practiced worldwide. Yoga has been used in the primary and secondary prevention of Cardiovascular disease(CVD) including Coronary artery disease(CAD). Many evidences suggest that yoga is safe and efficacious in reducing various risk factors of CAD such as stress, anxiety, depression, diabetes, obesity and hypertension. Yoga can be helpful in any form of preventive measure for CAD. If used as primordial preventive measure can lead to significant reduction in cardiovascular and many more non- communicable diseases.

Purpose of Trial:
Yoga has been associated with improvement in general health, cardiovascular risk prevention factors, and other NCDs. Yoga has shown improvement in BMI, Blood pressure, lipid profile, lesion progression in CAD. However, the biomolecules through which yoga acts on body is unclear in CAD. Thus this study investigates different risk factors of CAD. The study aims to investigate various immunological, inflammatory and neuropsychological markers of CAD patients. The study will aid in revealing the biomolecule that brings about the positive health effect in yoga practitioners. The study will generate evidence for the efficacy of Yoga protocol which is used in CAD care, later it will help in slowing down the progression of disease.

 
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