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CTRI Number  CTRI/2025/02/079960 [Registered on: 04/02/2025] Trial Registered Prospectively
Last Modified On: 26/12/2024
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 in Children with Bronchial Asthma 
Scientific Title of Study   The Effect of Adjuvant Yoga Therapy on Inflammatory Biomarkers in Children with Bronchial Asthma - A 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  NEMICHAND VERMA 
Designation  PH.D. SCHOLAR 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH 
Address  DEPARTMENT OF TELEMEDICINE, 6TH FLOOR, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH

Dehradun
UTTARANCHAL
249203
India 
Phone  7060105125  
Fax    
Email  NEMIDSVV204@GMAIL.COM  
 
Details of Contact Person
Scientific Query  
Name  MEENU SINGH 
Designation  EXECUTIVE DIRECTOR & CEO  
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH 
Address  DIRECTOR OFFICE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH

Dehradun
UTTARANCHAL
249203
India 
Phone  8146481757  
Fax    
Email  MEENUSINGH4@GMAIL.COM  
 
Details of Contact Person
Public Query  
Name  SRILOY MOHANTY 
Designation  SENIOR MEDICAL OFFICER  
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH 
Address  DEPARTMENT OF AYUSH, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH

Dehradun
UTTARANCHAL
249203
India 
Phone  9560540977  
Fax    
Email  SRILOY21@GMAIL.COM  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH, VEERBHADRA MARG, PASHULOK, RISHIKESH, UTTARAKHAND, PIN- 249203, INDIA,  
 
Primary Sponsor  
Name  AIIMS RISHIKESH 
Address  VEERBHADRA MARG, RISHIKESH, DEHRADUN, UTTARAKHAND, INDIA PIN-249203 
Type of Sponsor  Government medical college 
 
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 
MEENU SINGH  ALL INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH  ROOM NO 02, DEPARTMENT OF PEDIATRICS, OPD BLOCK 2ND FLOOR, AIIMS RISHIKESH
Dehradun
UTTARANCHAL 		 8146481757

MEENUSINGH4@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  
Status 
Not Applicable 
 
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 1 PUFF/DAY FOR 12 WEEKS. 
Intervention  INTEGRATED YOGA INTERVENTION  THE INTEGRATED YOGA INTERVENTION COMPRISING SUKSHMA VYAYAMA (LOOSENING EXERCISE), YOGASANA (YOGA POSTURES), PRANAYAMA (BREATHING EXERCISE), AND SHATKARMA (CLEANSING PRACTICE) . THE DURATION AND FREQUENCY OF THIS INTERVENTION WILL BE 40 MINUTES, MINIMUM 3 DAYS A WEEK (36 SESSIONS) FOR 12 WEEKS. 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  1. PATIENTS DIAGNOSED WITH MILD AND MODERATE ASTHMA FOLLOWING GLOBAL INITIATIVE FOR ASTHMA GUIDELINES.
2. PATIENTS AGED BETWEEN 07-17 YEARS.
3. PATIENTS HAVING HISTORY OF ASTHMA AT LEAST FOR 06 MONTHS.
4. WHOSE PARENTS PROVIDE WRITTEN CONSENT AND ASSENT FROM CHILDREN. 
 
ExclusionCriteria 
Details  1. ONE WHO IS ALREADY ENGAGED IN SIMILAR THERAPIES LIKE ALREADY DOING YOGA PRACTICES.
2. CHILDREN TAKING ORAL STEROIDS, ANTI-ANXIETY OR ANTI-DEPRESSANT MEDICINES.
3. CHILDREN WITH SEVERE CARDIOVASCULAR & NEUROMUSCULAR DISEASE, TUBERCULOSIS, OR ANY
OTHER CONCOMITANT PULMONARY DISEASE.
4. PATIENTS WITH A HISTORY OF ANY MAJOR SURGERY.
5. CHILDREN WITH ANY SEVERE PSYCHOLOGICAL DISEASE.
6. CHILDREN WITH UNCONTROLLED EPILEPSY AND MOVEMENT DISORDERS (TREMORS PARKINSON’S DISEASE ETC.) 
 
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 
TO EVALUATE THE EFFICACY OF ADJUVANT YOGIC INTERVENTION ON CHANGES IN ASTHMA-SPECIFIC INFLAMMATORY CYTOKINES- IL-4, IL-5, AND IL-13 AMONG CBA PATIENTS IN COMPARISON TO THE CONTROL GROUP OVER 3 MONTHS  AT BASELINE AND FINAL ASSESSMENT END OF THE 12TH WEEK 
 
Secondary Outcome  
Outcome  TimePoints 
TO COMPARE ASTHMA-RELATED CRISIS EVENTS INCLUDING ACUTE EXACERBATIONS, EMERGENCY CARE VISITS, HOSPITALIZATION, NEED OF NEBULIZATION, AND FREQUENCY USE OF BRONCHODILATORS.   AT BASELINE AND FINAL ASSESSMENT END OF THE 12TH WEEK 
TO COMPARE THE EFFECT OF YOGA INTERVENTION ON IMPROVEMENT IN FUNCTIONAL EXERCISE CAPACITY  AT BASELINE AND FINAL ASSESSMENT END OF THE 12TH WEEK 
TO EVALUATE THE EFFECT OF ADJUVANT YOGA THERAPY ON PULMONARY FUNCTIONS AMONG CHILDREN WITH BRONCHIAL ASTHMA  AT BASELINE AND FINAL ASSESSMENT END OF THE 12TH WEEK 
TO EVALUATE THE ASTHMA-RELATED QUALITY OF LIFE OF CHILDREN WITH BRONCHIAL ASTHMA   AT BASELINE AND FINAL ASSESSMENT END OF THE 12TH WEEK 
TO COMPARE THE CHANGES IN SLEEP QUALITY USING THE PAEDIATRIC SLEEP QUESTIONNAIRE (PSQ)   AT BASELINE AND FINAL ASSESSMENT END OF THE 12TH WEEK 
 
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   Phase 2 
Date of First Enrollment (India)   17/02/2025 
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 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  

Asthma is a prevalent non-communicable disease characterized by chronic airway inflammation and variable airflow obstruction. The global prevalence of asthma in children and adolescents is 9.1% and 11% respectively. The common symptoms of childhood bronchial asthma are breathing difficulty, chest tightness, and frequent coughing, which affects their quality of life, academic performance, and restricted activities. such as participation in sports, cycling swimming etc. Despite availability of pharmacological treatments such as long-acting beta 2 agonists and short-acting beta 2 agonists, which are managing symptoms to a great extent, but still they have multiple side effects such as fever, nausea therefore as an add on intervention is required to minimize the adverse effects and efficient asthma management. Yoga has evolved as an evidence based holistic approach for mind body medicine and literatures suggest that yoga as an add on intervention has a significant impact on children with bronchial asthma, improving quality of life and lung function etc. This study aims to evaluate the effect of adjuvant yoga therapy on inflammatory biomarkers (IL-4, IL-5, IL-13) in children with bronchial asthma. Our secondary objectives are comparing asthma related crisis events, functional exercise capacity, pulmonary functions (PEFR, FEV, FVC), quality of life and sleep quality between both intervention and control groups.

 
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