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CTRI Number  CTRI/2025/08/092365 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 04/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Holistic Approach of Yoga for Asthma and Lung Function 
Scientific Title of Study   Outcomes of Holistic Approach of Yoga as Integrative Medicine on Selected Parameters Among Asthma Patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Muthulakshmi K 
Designation  Scholar 
Affiliation  Meenakshi Academy of Higher Education and Research 
Address  Dept: Faculty of Yoga Science and Therapy Division: 3rd Floor Room No: 303 No: 12 Vembuliamman Koil Street West K K Nagar Chennai

Chennai
TAMIL NADU
600078
India 
Phone  8015437160  
Fax    
Email  mvr.vishnu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr P Malaialagu 
Designation  Deputy Director 
Affiliation  Meenakshi Academy of Higher Education and Research 
Address  Physical Education and Sports Meenakshi Academy of Higher Education and Research No: 12 Vembuliamman Koil Street West K K Nagar Chennai

Chennai
TAMIL NADU
600078
India 
Phone  9994206540  
Fax    
Email  Pmalaialagu@madch.edu.in  
 
Details of Contact Person
Public Query  
Name  Muthulakshmi K 
Designation  Scholar 
Affiliation  Meenakshi Academy of Higher Education and Research 
Address  Dept: Faculty of Yoga Science and Therapy Division: 3rd Floor Room No: 303 No: 12 Vembuliamman Koil Street West K K Nagar Chennai

Chennai
TAMIL NADU
600078
India 
Phone  8015437160  
Fax    
Email  mvr.vishnu@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Muthulakshmi K 
Address  Dept: Faculty of Yoga Science and Therapy Division: 3 rd Floor Room No: 303 No 12 Vembuliamman Koil Street West K K Nagar Chennai 600078 TAMIL NADU India  
Type of Sponsor  Other [Scholar] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr V Devanathan  Asthma and Diabetes Studio  No 6 Vadivalan Nagar Velachery Chennai 600 042 Opposite to Velachery Railway Station
Chennai
TAMIL NADU 		 883 854 2180

dr.vdevanathan@gmail.com 
Dr P Malaialagu  Meenakshi Academy of Higher Education and Research  Dept: Faculty of Yoga Science and Therapy Division: 3rd Floor Room No. 303 No 12 Vembuliamman Koil Street West K K Nagar
Chennai
TAMIL NADU 		 9994206540

Pmalaialagu@madch.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Meenakshi Academy of Higher Education and Research Institutional Human Ethics Committee  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  Control Group   Control Group will continue with their prescribed medication and lifestyle as advised by their healthcare provider 
Intervention  Yogic Practices  Asanas Pranayama Mudra Bandha Meditation Relaxation Frequency: 5 days per week Total Duration: 4 Months 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Early adulthood individuals (aged 30-45 years) with asthma symptoms residing in and
around Chennai

Willingness to participate in the study and signing of the written consent form

Diagnosis of Asthma based on Asthma classification and symptoms as defined by the National Asthma Education and Prevention Program (NAEPP) and Global initiative for Asthma (GINA) classification of Asthma severity
Individuals who have not practiced yoga or any other form of exercise within the past
6 months

Assessed suitable for practicing yoga therapy based on physical exam

 
 
ExclusionCriteria 
Details  Patients with severe persistent asthma, pregnant women

Active clinical surgery or other major clinically significant disorder/ disease, history
of Tuberculosis TB, Chronic obstructive pulmonary disease (COPD)

Other Respiratory Conditions such as Lung Fibrosis, Pulmonary embolism

Chronic illnesses like cardiovascular disease, recent myocardial infarction, uncontrolled hypertension, diabetes, musculoskeletal issue and history of arthritis

Individuals who do not provide informed consent

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
what: IgE Absolute Eosinophil
Count
When: Pre and Post Intervention 		 4 Months 
 
Secondary Outcome  
Outcome  TimePoints 
What: Respiratory
Rate RR
Breath Holding
Time BHT
Spirometry
PFT Values of FVC FEV1
FEV1/FVC%
PEF FEF25-75 FEF25 FEF50 FEF75
Asthma quality of
Life questionnaire AQLQ
Perceived Stress Scale
PSS 10 Questionnaire 		 4 Months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   04/09/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
This study would be conducted for the partial fulfilment of the Ph.D study  at Meenakshi Academy of Higher Education and Research (Deemed to be  University), Chennai.

ABSTRACT

BACKGROUND

Asthma is a chronic inflammatory respiratory disorder marked by episodes of breathlessness, coughing, and wheezing due to airway hyper-responsiveness. Despite medical advancements, long-term reliance on medications poses challenges, including side effects and poor adherence. Early adulthood aged 18–45 years is a crucial period where stress, sedentary lifestyles, and environmental triggers can exacerbate asthma symptoms, impacting overall well-being. Integrative approaches such as yoga have shown promise in improving lung function, reducing stress, and enhancing quality of life. However, research on its long-term impact of yoga on specific respiratory and psychological parameters remains limited. This study aims to investigate the effectiveness of yoga as an integrative therapy for asthma management.

 

AIM

The purpose of the study is to investigate the outcomes of holistic approach of yoga as an integrative medicine on selected parameters in patients with asthma.

 

METHODS AND DESIGN

This study is a two-armed randomized controlled trial examining the outcomes of yoga therapy in asthma patients. Participants will be selected based on Global Initiative for Asthma (GINA 2024) and National Asthma Education and Prevention Program (NAEPP 2020) guidelines, focusing on individuals with intermittent to moderate persistent asthma. The study will include men and women aged 30 - 45 residing in and around Chennai. Participants will be fully informed about the study, and written consent will be obtained before data collection. Eligible participants will complete a structured questionnaire covering demographics, lifestyle, Body Mass Index (BMI), and other health-related factors. Stress levels and quality of life will be assessed using the Perceived Stress Scale (PSS-10) and the Asthma Quality of Life Questionnaire (AQLQ). Medical histories will be reviewed through hospital records to gather additional clinical insights. A total of 80 participants will be randomly assigned to two groups: a yoga therapy group (n=40) and a control group (n=40). The yoga therapy group will receive structured yogic practices for four months, five days a week, with each session lasting 60 minutes. The control group will continue with their prescribed medication and lifestyle modifications as advised by their healthcare provider. Pre- and post-test assessments will be conducted for all outcome measures.


 
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