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CTRI Number  CTRI/2025/04/086022 [Registered on: 30/04/2025] Trial Registered Prospectively
Last Modified On: 30/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study on How Pranayama Affects Breathing in Smokers and Non-Smokers 
Scientific Title of Study   An Interventional Study to Compare the Effect of Pranayama on Smokers and Non-Smokers with Respect to Respiratory Parameters. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Komal Vilas Patil 
Designation  Pg Scholar 
Affiliation  Parul Insitute Of Ayurved And Research 
Address  Dept. Of Kriya Sharir Parul Insitute Of Ayurved And Research, Ishwarpura Tal. Waghodia, Dist Vadodara Pin:391760, Gujrat, India

Vadodara
GUJARAT
391760
India 
Phone  7709417599  
Fax  7709417599  
Email  kp1sign@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Vaibhav A. Biradar 
Designation  Professor 
Affiliation  Parul Insitute Of Ayurved And Research 
Address  Dept. Of Kriya Sharir Parul Insitute Of Ayurved And Research, Ishwarpura Tal. Waghodia, Dist Vadodara Pin:391760, Gujrat, India

Vadodara
GUJARAT
391760
India 
Phone  9890273347  
Fax    
Email  vaibhav29feb@gmail.com  
 
Details of Contact Person
Public Query  
Name  Parul Institute of Ayurved and Research 
Designation  Professor 
Affiliation  Parul Insitute Of Ayurved and Research 
Address  Dept. Of Kriya Sharir Parul Insitute Of Ayurved And Research, Ishwarpura Tal. Waghodia, Dist Vadodara Pin:391760, Gujrat, India

Vadodara
GUJARAT
391760
India 
Phone  9890273347  
Fax    
Email  vaibhav29feb@gmail.com  
 
Source of Monetary or Material Support  
Parul Institute of Ayurved and Research, Ishwarpura, Tal. Waghodia, Dist. Vadodara Pin:391760, Gujrat, India 
 
Primary Sponsor  
Name  Dr Komal Vilas Patil 
Address  Parul Institute of Ayurved and Research, Ishwarpura Tal. Waghodia, Dist. Vadodara Pin:391760, Gujrat, India 
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 Komal Vilas Patil  Room no. 201, Dept. of Kriya Sharir Paul Institute of Ayurved and Research  Parul University, P.O Limda, Tal.Waghodia,Dist. Vadodara, Gujarat, India 391760
Vadodara
GUJARAT 		 7709417599

kp1sign@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-PIAR HR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Smokers and Non smokers 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Pranayama- once a Day, Empty Stomach For 30 Min., Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  24.00 Year(s)
Age To  40.00 Year(s)
Gender  Male 
Details  1.Not Practicing Any Other Type Of Physical Exercises.
2.Smokers: Males Who Have Been Smoking Regularly For At least Last One Year.
3.Nonsmokers: Individuals Who Are Not Habituated Smoking Completely.
4.Willing To Give Consent to Participate in The Pranayama Intervention and Attend Scheduled Sessions.  
 
ExclusionCriteria 
Details  1.History Of Chronic Respiratory Diseases Such as Asthma, Chronic Obstructive Pulmonary Disease (COPD), Bronchitis.
2.History Of Active Sport training, Previous Experience of Yoga.
3.History Of Major Medical Illness Such as Tuberculosis, Hypertension, Diabetes Mellitus Bronchial Asthma.
4.History Of Major Surgery in the Recent Past.
5.Having History of Cardiorespiratory Diseases.
3.Any congenital Deformity.
7.Athelets
8. History of Any Psychological Disorders.
9. Not Willingness to Give Consent to Participate in The Study and Attend Scheduled 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in respiratory parameters after Pranayama intervention over a specified duration in smokers and non-smokers.  1year 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of baseline respiratory function between smokers and non-smokers.  4 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   27/05/2025 
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="0"
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 interventional study aims to evaluate and compare the effect of Pranayama (yogic breathing techniques) on respiratory parameters among smokers and non-smokers. Smoking is known to significantly impair pulmonary functions, while Pranayama has been associated with improved lung capacity and respiratory efficiency.The study will involve 60 male participants aged 24–40 years, categorized into two groups: smokers and non-smokers (30 in each group). All participants will undergo a 4-week structured Pranayama intervention. Baseline and post-intervention assessments will be conducted using Pulmonary Function Tests (PFTs) to measure parameters such as FVC, FEV1, FEV1/FVC ratio, and PEFR.The primary aim is to assess the effectiveness of Pranayama in improving respiratory parameters within each group and compare the extent of improvement between smokers and non-smokers. This study intends to explore whether regular Pranayama practice can serve as a non-pharmacological supportive measure to enhance lung function, especially in individuals at risk due to smoking.

 
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