| CTRI Number |
CTRI/2025/07/091981 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to compare the effect of Buteyko and Pranayama Breathing techniques on the Peak Expiratory Flow Rate and Quality of life in Patients with bronchial asthma. |
|
Scientific Title of Study
|
Comparison of the effects of Buteyko and Pranayama Breathing techniques on the Peak Expiratory Flow Rate and Quality of life in Patients with bronchial asthma. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priti Suroshe |
| Designation |
Associate Professor |
| Affiliation |
D. Y. Patil college of physiotherapy pimpri pune |
| Address |
Dr. D. Y. Patil College of Physiotherapy, Pimpri, Pune
Dr. D. Y. Patil Vidyapeeth, Pimpri,
Pune
411018
Maharashtra
India Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune 411018 Pune MAHARASHTRA 411018 India |
| Phone |
09096183765 |
| Fax |
|
| Email |
priti.suroshe55@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Priti Suroshe |
| Designation |
Associate Professor |
| Affiliation |
D. Y. Patil college of physiotherapy pimpri pune |
| Address |
Dr. D. Y. Patil College of Physiotherapy, Pimpri, Pune 411018
Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune 411018
Pune MAHARASHTRA 411018 India |
| Phone |
09096183765 |
| Fax |
|
| Email |
priti.suroshe55@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Roopa Desai |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Dr. D.Y Patil college of physiotherapy , Dr. D.Y Patil Vidyapeeth, Pimpri , Pune
Pune MAHARASHTRA 411018 India |
| Phone |
9890992383 |
| Fax |
|
| Email |
roopa.desai@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College of Physiotherapy Sant Tukaram Nagar , Pimpri,
Maharashtra
Pune
India
411018 |
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil College of Physiotherapy |
| Address |
Dr. D. Y Patil college of physiotherapy, Dr. D.Y Patil Vidyapeeth, Pimpri, Pune |
| Type of Sponsor |
Other [(Physiotherapy College)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Priti Suroshe |
Dr. D.Y. Patil College of Physiotherapy |
Dr. D.Y. Patil College of Physiotherapy, Out Patient Department, Sant Tukaram Nagar, Pimpri,
Pune
411018 Pune MAHARASHTRA |
09096183765
priti.suroshe55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Dr. D.Y Patil Vidyapeeth, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J453||Mild persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1. Buteyko breathing 2. pranayama breathing 3. control group |
1. Buteyko breathing technique to be practiced 15-20 minutes daily 5 days a week for 12 weeks.
duration of study is for 3 months
2. pranayama breathing technique to be practiced for 30 minutes a day , 5 days a week for 12 weeks. which includes anulom vilom 5-10 minutes daily, kapalbharti 3-5 minutes at a time, bhastrika 3-5 minutes at a time and gradually increasing as tolerated.3. control group patients receiving standard conventional asthma care without addictional breathing techniques.
Duration of study is 3 months |
| Intervention |
Buteyko and pranayama breathing technique |
all the patients will receive the Buteyko or Pranayama breathing technique for 5 days a week for 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Both |
| Details |
1. adults ages 20 -49 years diagnosed cases of bronchial asthama.
2. stable on medication for at least 1 month prior to study.
3. willingness to participate and provide informed consent. |
|
| ExclusionCriteria |
| Details |
1.severe asthma or respiratory co-morbidities.
2. recent respiratory infections or exacerbations (within 4 weeks)
3. pregnant or lactating mother.
4. prior practice of buteyko or pranyama technique. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.peak expiratory flow rate -using peak flow meter. 2.quality of life assessed using asthma quality of life questionnaire(AQLQ) |
1. Beginning of Study.
2. End of 6 weeks
3. End of 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| asthma symptom control using asthma control test (ACT). medication use( frequency of resque inhaler use) |
1. beginnning of day 1 pre treatment
2. after 6 weeks post treatment.
after 12 weeks post treatment. |
|
|
Target Sample Size
|
Total Sample Size="116" Sample Size from India="116"
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)
|
18/08/2025 |
| 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="5" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
NULL HYPOTHESIS
There is no significant difference in the effects of Buteyko and Pranayama breathing technique in bronchial asthmatic persons.
ALTERNATIVE HYPOTHESIS
H1 : The effect of buteyko breathing technique is better than pranayama breathing in bronchial asthamatic patients. H2 : The effect of pranayama breathing technique is better than buteyko breathing technique in bronchial asthamatic persons.
Patients full filling inclusion criteria will be taken for the study . Informed consent will be taken. patients will be alloted in three groups A,B, C by simple convenience sampling method.
GROUP A - 39 Patients receiving Buteyko breathing technique.
GROUP B- 39 Patients receiving Pranayama breathing technique.
GROUP C - 39 control group on conventional bronchial asthma treatment.
Group A and Group B will receive treatment 5 days a week for 12 weeks.
Outcome measure will be be taken on day 1 pre treatment, after 6 weeks and after 12 weeks post treatment. |