| CTRI Number |
CTRI/2025/01/079465 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Other (Specify) [Breathing Exercises] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Outcomes of Yoga and Breathing Exercise Interventions vs. Breathing Exercise Alone on Lung Function in Asthma Patients. |
|
Scientific Title of Study
|
Effects of combined yoga therapy with breathing exercises versus breathing exercises alone on the pulmonary function test parameters in mild to moderate bronchial asthma patients taking standard care treatment: a randomized control 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 |
Sre Soorya K P |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry |
| Address |
Department of Physiology,
First floor,
Academic Centre,
Jawaharlal Institute of Postgraduate Medical Education and Research,
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8870357541 |
| Fax |
|
| Email |
kpsresoorya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dhanalakshmi Y |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry |
| Address |
Department of Physiology,
First floor,
Academic Centre,
Jawaharlal Institute of Postgraduate Medical Education and Research,
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9444781210 |
| Fax |
|
| Email |
saidhanalakshmi04@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dhanalakshmi Y |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry |
| Address |
Department of Physiology,
First floor,
Academic Centre,
Jawaharlal Institute of Postgraduate Medical Education and Research,
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9444781210 |
| Fax |
|
| Email |
saidhanalakshmi04@yahoo.com |
|
|
Source of Monetary or Material Support
|
| JIPMER Intramural Research Fund,
Jawaharlal Institute of Postgraduate Medical Education and Research,
Puducherry 605006 |
|
|
Primary Sponsor
|
| Name |
JIPMER Intramural Research Fund |
| Address |
JIPMER,
Dhavantari Nagar,
Pondicherry-605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sre Soorya K P |
Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry-605006 |
Department of Physiology,
Academic Center
Pondicherry
PONDICHERRY |
8870357541
kpsresoorya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Interventional Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP 1 |
patients with mild to moderate asthma on conventional drug
therapy. |
| Intervention |
GROUP 2 |
patients with mild to moderate asthma on conventional drug
therapy receiving breathing exercises for 12 weeks. |
| Intervention |
GROUP 3 |
patients with mild to moderate asthma on conventional
drug therapy receiving breathing exercises and yoga therapy for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Mild to moderate severity of bronchial asthma patients of either gender
of age group 20-60 years on standard care, visiting Jawaharlal Institute of Postgraduate Medical Education and Research pulmonology OPD for treatment will be included in this study. |
|
| ExclusionCriteria |
| Details |
Severe asthma patients.
Patients already practicing yoga, breathing exercises or regular physical activity
Patients with uncontrolled hypertension with drugs.
Patients with diabetes mellitus.
Pregnant females.
Subjects with endocrine disorders.
Subjects with severe obesity.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Pulmonary Function Test Parameters |
Baseline and after 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the level of inflammatory markers IL-4,IL-5,IL-6,IL-13 |
Baseline & after 12 weeks. |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
05/01/2026 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Bronchial asthma is a chronic inflammatory disease affecting millions globally, with a significant burden in India. Despite standard treatments like steroids and bronchodilators, patients often experience chronic stress and reduced quality of life. Yoga, pranayama, and meditation have shown potential in improving pulmonary function, reducing stress, and enhancing respiratory muscle strength. This study aims to assess the combined impact of structured yoga therapy and breathing exercises alongside standard pharmacotherapy in mild to moderate asthma patients. Three randomized groups will be evaluated for pulmonary function, inflammatory biomarkers, and quality of life over 12 weeks. The study introduces a novel, structured protocol tailored for asthma patients, developed by MDNIY and validated by JIPMER, targeting a South Indian population. The expected outcomes include improved pulmonary function, better asthma control, enhanced quality of life, and reduced inflammation, establishing yoga and breathing exercises as valuable adjunct therapies for asthma management. |