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CTRI Number  CTRI/2025/01/078989 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Yoga on Pulmonary Function in Individuals Exposed to air pollution in DELHI-NCR 
Scientific Title of Study   IMPACT OF YOGA ON PULMONARY FUNCTION AND QUALITY OF LIFE IN INDIVIDUALS EXPOSED TO AIR POLLUTION IN DELHI-NCR 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  sparsh kakkar 
Designation  Ph.D. scholar 
Affiliation  Amity University 
Address  Amity University Amity Rd, Sector 125, Noida, Uttar Pradesh 201301

Faridabad
HARYANA
121001
India 
Phone  9910240464  
Fax    
Email  sparsh.kakkar@s.amity.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Garima Jaiswal 
Designation  Assistant professor 
Affiliation  Amity University 
Address  Amity university, Amity Rd, Sector 125, Noida, Uttar Pradesh 201301

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  8899799508  
Fax    
Email  gjaiswal1@amity.edu  
 
Details of Contact Person
Public Query  
Name  Dr Garima Jaiswal 
Designation  Assistant professor 
Affiliation  Amity University 
Address  sector-125, noida


UTTAR PRADESH
201301
India 
Phone  8899799508  
Fax    
Email  gjaiswal1@amity.edu  
 
Source of Monetary or Material Support  
Amity University, sector-125, noida, Uttar pradesh, India, 201303 
 
Primary Sponsor  
Name  Sparsh kakkar 
Address  H.no157, sector 46, Faridabad, Haryana, 121001 
Type of Sponsor  Other [Self] 
 
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 
Dr Umesh Kumar   Amity University  Amity university, Amity institute of Indian system of medicine, Amity Rd, Sector 125, Noida, Uttar Pradesh 201301
Gautam Buddha Nagar
UTTAR PRADESH 		 9910765508

ukumar1@amity.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Amity University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  controlled  day to day lifestyle duration - 3 months 
Intervention  Yoga protocol   Yoga Practice Protocol 1. Standing Postures (Warm-up & Strengthening) Hold each posture for 1 minute. Repeat the sequence 2 rounds: Halasana Tadasana Vrikshasana Padahastasana Trikonasana Garudasana 2. Sitting Postures (Flexibility & Stability) Hold each posture for 1 minute. Repeat the sequence 2 rounds: Padmasana Vajrasana Ushtrasana Bhadrasana Shashankasana Ardha Matsyendrasana Gomukhasana 3. Prone Postures (Core & Back Strengthening) Hold each posture for 1 minute. Repeat the sequence 2 rounds: Makarasana Bhujangasana Shalabhasana Dhanurasana 4. Supine Postures (Relaxation & Flexibility) Hold each posture for 1 minute. Repeat the sequence 2 rounds: Ardha Halasana Setubandhasana Pavanmuktasana Pranayama Practice 1. Sheetali Pranayama: Technique: Inhale through curled tongue, exhale through nose Time: 3 minutes/session Repetitions: 5 rounds 2. Bhramari Pranayama: Technique: Humming sound while exhaling Time: 5 minutes/session Repetitions: 7 rounds 3. Jal Neti (Nasal Cleansing): Technique: Use saline water to cleanse nasal passages Time: 5–10 minutes Frequency: 1 session/day 4. Kapalbhati: Technique: Active exhalations, passive inhalations Time: 5 minutes/session Repetitions: 3 rounds (30 strokes/round)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  people residing in Delhi-NCR exposed to air pollution  
 
ExclusionCriteria 
Details  volunteer suffering from Asthma, COPD, bronchitis patients  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
significant change in pulmonary function  baseline assessment and after 12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
1. better quality of life  3 months 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/01/2025 
Date of Study Completion (India) 28/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   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  

The project titled “Impact of Yoga on Pulmonary Function and Quality of Life in Individuals Exposed to Air Pollution in Delhi-NCR” aims to evaluate how a tailored yoga protocol can mitigate the adverse effects of air pollution on respiratory health and overall well-being.

Key Details:

  1. Research Context: Delhi-NCR’s air pollution is a significant health hazard, contributing to respiratory and cardiovascular issues, Yoga, combining asanas, pranayama, and meditation, may offer a holistic approach to improving pulmonary function and quality of life.

  2. Study Design: Type: Randomized, controlled, two-arm, interventional study., Participants: 86 individuals (43 in the experimental group and 43 in the control group), aged 18-35, residing in Delhi-NCR, and exposed to air pollution, Intervention: A specific yoga protocol, three times a week for three months, focusing on respiratory health and stress reduction, Control: Participants will be waitlisted and monitored.

  3. Assessment Parameters: Pulmonary function via spirometry, Quality of life using standardized tools like the Saint George Respiratory Questionnaire (SGRQ), Psychological well-being through stress scales.

  4. Research Objectives: Assess the effect of yoga on pulmonary function, Evaluate changes in expiratory rates post air pollution exposure, Analyze yoga’s impact on quality of life.

  5. Outcome Measures: Quantitative improvements in pulmonary metrics (e.g., FVC, FEV1), Enhanced quality of life and reduced stress levels.

  6. Significance: Addresses a critical health issue in a highly polluted urban setting, Provides evidence for yoga as a sustainable, non-pharmacological intervention.

This research could serve as a model for integrating yoga into public health strategies to combat the effects of air pollution.

 
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