| CTRI Number |
CTRI/2024/10/075394 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of yoga on asthma in children |
|
Scientific Title of Study
|
Effect of Yoga Therapy on Suppressor of Cytokine Signaling (SOCs) Gene Expression in Children with Asthma: A Prospective Randomized Controlled 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 |
Prof Meenu Singh |
| Designation |
Executive director & CEO AIIMS Rishikesh |
| Affiliation |
AIIMS Rishikesh |
| Address |
Director office AIIMS Rishikesh 249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8146481757 |
| Fax |
|
| Email |
meenusingh4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dheeraj Dabas |
| Designation |
Ph.D Scholar |
| Affiliation |
AIIMS Rishikesh |
| Address |
Floor 6 Dept. of Telemedicine, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8448304402 |
| Fax |
|
| Email |
dheerajdabas0@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sriloy Mohanty |
| Designation |
Senior Medical Officer |
| Affiliation |
AIIMS Rishikesh |
| Address |
Dept. of AYUSH, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9560540977 |
| Fax |
|
| Email |
sriloy21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Yoga & Naturopathy (CCRYN) Address. MINISTRY OF AYUSH. AYUSH BHAWAN, B Block, GPO Complex, INA, NEW DELHI, INDIA - 110023. |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Yoga and Naturopathy |
| Address |
MINISTRY OF AYUSH. AYUSH BHAWAN, B Block, GPO Complex, INA, NEW DELHI - 110023 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS Rishikesh |
Veerbhadra Road AIIMS Rishikesh-249203 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sriloy Mohanty |
All India Institute of Medical Sciences Rishikesh |
Room no 2, Dept. of Pediatrics OPD Block 2nd floor
Dehradun
UTTARANCHAL |
9560540977
Sriloy21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Rishikesh |
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 |
Formoterol(200mg) or Budesonide(200mg) |
The comparator agent for this study will be either combination of both formoterol and Budesonide or Budesonide monotherapy 200mg one puff/day for 12 weeks. |
| Intervention |
Integrated Yoga Intervention( Asana, Pranayama, Dhyana) |
The Integrated yoga intervention will comprise of 40 minutes module that includes loosening exercises(Sukshma Vyayama), yoga postures(Asana), breathing practices(Pranayama), and relaxation. The duration and frequency of intervention will be 12 weeks and 3 session/week(36 Sessions) |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Aged between 7 and 18 years of either gender
With a minimum bronchial asthma history for more than 6 months diagnosed through the Global Initiative for Asthma guideline for chronic bronchial asthma
|
|
| ExclusionCriteria |
| Details |
If patients have any concomitant pulmonary disease or any other systemic disease.
If patients suffering from Contraindications to yoga and exercise testing
If patients have a history of recent major surgery
If patients are participating in any other trial, receiving any additional complementary therapy
Participant practicing structured yoga before the recruitment in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome for this trial will be the change in gene expression level of Supression of Cytokine Signalling(SOCS) gene 1,3,5 in children with bronchial asthma |
Time point for primary outcome assessment will be 0 week for baseline and 12 weeks for post intervention assesment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the efficacy of yoga therapy in improving asthma symptoms using ACT and overall quality of life using PAQLQ in children with asthma undergoing yoga therapy versus those who receive standard care. |
Time point for assessment will be 0 week for baseline and 12 weeks for post intervention assesment |
| To evaluate changes in lung function parameters, including FEV1, FVC and PEFR in children with asthma undergo yoga therapy intervention versus who receives standard care. |
Time point for assessment will be 0 week for baseline and 12 weeks for post intervention assesment |
| To evaluate the changes in blood eosinophil count and IgE level in children with asthma who undergo yoga therapy versus who receives only standard care. |
Time point for assessment will be 0 week for baseline and 12 weeks for post intervention assesment |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
21/11/2024 |
| 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)
Modification(s)
|
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 - NO
|
|
Brief Summary
|
Asthma is a chronic respiratory condition with an estimated prevalence of about 7.9% and 9.1% of the pediatric population in India and globally respectively. Pharmacological treatment for asthma significantly impairs the quality of life and is also associated with several comorbidities such as nausea, fever, bronchospasm, vomiting, headache, pain, dizziness, cough, allergic reaction, dry mouth, sweating, etc. based on available literature it is found that Suppressor of Cytokine Signalling (SOCS) play a pivotal role in regulating excess cytokine signaling that is responsible for chronic inflammation in bronchial asthma. Interventions similar to the yoga modality such as pulmonary rehabilitation and sequential inspiratory muscle exercise found a significant impact on pulmonary function and exercise capacity by modulating SOCS JAK-STAT pathway in patients with different pulmonary disorders such as COPD and cystic fibrosis. To know the mechanistic pathway involved in improving pulmonary functions by yoga therapy in asthma this study is designed as a Randomized Controlled Trial with the primary objective is to to analyzing the gene expression of SOCS1,3,5 in peripheral blood mononuclear cells (PBMCs) using qRT-PCR in children with asthma undergoing 12 weeks of yoga therapy. The secondary objective for this study is designed as follows
- To assess the efficacy of yoga therapy in improving asthma symptoms using ACT and overall quality of life using PAQLQ in children with asthma undergoing yoga therapy versus those who receive standard care.
- To evaluate changes in lung function parameters, including FEV1 and PEFR in children with asthma undergo yoga therapy intervention versus who receives standard care.
- To evaluate the changes in blood eosinophil count in children with asthma who undergo yoga therapy versus those who receive only standard care.
|