| 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
|
|
|
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
|
|
|
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. |