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CTRI Number  CTRI/2024/09/073299 [Registered on: 03/09/2024] Trial Registered Prospectively
Last Modified On: 03/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Single Arm Study 
Public Title of Study   Preparing validating and Testing a Standardized Yoga Module on pulmonary function test in COPD Patients  
Scientific Title of Study   Development Validation and Pilot Testing of a Standard Yoga Module for Chronic Obstructive Pulmonary Disease 
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 Ashween Bilagi 
Designation  Assistant professor HOD 
Affiliation  Sir Devaraj Urs Academy of Higher Education and Research 
Address  Department of Integrative Medicine Sir Devaraj Urs Academy of Higher Education and Research Tamaka kolar

Kolar
KARNATAKA
563103
India 
Phone  9886666636  
Fax    
Email  ayushashwin@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashween Bilagi 
Designation  Assistant professor HOD 
Affiliation  Sir Devaraj Urs Academy of Higher Education and Research 
Address  Department of Integrative Medicine Sir Devaraj Urs Academy of Higher Education and Research Tamaka kolar

Kolar
KARNATAKA
563103
India 
Phone  9886666636  
Fax    
Email  ayushashwin@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashween Bilagi 
Designation  Assistant professor HOD 
Affiliation  Sir Devaraj Urs Academy of Higher Education and Research 
Address  Department of Integrative Medicine Sir Devaraj Urs Academy of Higher Education and Research Tamaka kolar

Kolar
KARNATAKA
563103
India 
Phone  9886666636  
Fax    
Email  ayushashwin@gmail.com  
 
Source of Monetary or Material Support  
Sri Devraja Urs Academy of Higher Education and Research, Tamaka- 563103, Kolar, Karnataka, India. 
 
Primary Sponsor  
Name  Dr Ashween Bilagi 
Address  Dept. of Integrative Medicine Tamaka-563103 Kolar Karnataka India  
Type of Sponsor  Other [Self ] 
 
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 Guruprasad TJ  RL Jalappa Hospital and Research Center  Department of Respiratory Medicine, First floor, Tamaka- 563103
Kolar
KARNATAKA 
8861736037

guru.g888@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Integrated yoga module and standard care.   A standard yoga module which will include Asana, Pranayama, Meditation and relaxation techniques. intervention will be given five days a week for four weeks.  
Comparator Agent  Not applicable   Not applicable  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Individuals diagnosed with mild and moderate COPD (GOLD 1&2).
2. Undergoing standard care.
 
 
ExclusionCriteria 
Details  1. Participants with a history of psychotic illnesses, and those on therapy for psychotic illness.
2. Other chronic conditions such as recent/history of stroke, post coronary artery bypass grafting, morbid obesity, uncontrolled diabetes, and uncontrolled hypertension and lung cancer.
3. Recent fractures / recent surgery, severe knee joint pain/ osteoarthritis will be excluded from the study.
4. Participants who have been exposed to Yoga practice in the last 3 months 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Pulmonary function test
2. Health related quality of life 
First day before yoga and after four weeks before yoga session. 
 
Secondary Outcome  
Outcome  TimePoints 
Experience and acceptance of yoga.   After four weeks before yoga session. 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/09/2024 
Date of Study Completion (India) 03/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 03/11/2025 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Chronic Obstructive Pulmonary Disease (COPD) is a widespread and progressively worsening respiratory condition affecting approximately 10.3% of the global population. Given the increasing prevalence of COPD, there is a growing need for effective complementary therapies alongside conventional treatments. Complimentary and alternate medicine (CAM) is used commonly among patients who have a longer period of asthma and COPD, A survey study showed around 86.3% of asthma and COPD patients used at least one type of CAM. along with medical treatments CAM benefits in improving respiration, reducing dyspnoea, and relaxing without getting any harm and yoga is one among them.

Yoga, with its ancient roots and modern relevance, has shown significance in improving respiratory function, reducing symptoms like dyspnoea and fatigue, and enhancing the overall quality of life in COPD patients. However, standardized yoga protocol for COPD is a major gap in current research. This study aims to address this gap by developing and validating a COPD-specific yoga module through collaboration with experts. The module will be pilot-tested to evaluate its impact on various aspects of COPD, including acceptance of the yoga module, physical symptoms, mental well-being, and quality of life. The ultimate goal is to establish a safe, feasible, and effective yoga intervention that can be integrated into pulmonary rehabilitation programs, offering a non-invasive, cost-effective approach to managing COPD.

 
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