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CTRI Number  CTRI/2025/08/092758 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 07/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect Of Buteyko Breathing Technique On Migraine  
Scientific Title of Study   Effect Of Buteyko Breathing Technique On Heart Rate Variability And Outcomes Of Migraine -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  Dr Shruti Mankar 
Designation  Assistant Professor 
Affiliation  PES Modern College of Physiotherapy  
Address  2nd floor, Dilkhush Bunglow,Galli No.1 Near Jijayi Garden Tapodham Parisar Warje
Department of Cardiovascular & Respiratory Physiotherapy, 1186,Shivajinagar,Off.J.M.Road, Pune-411005
Pune
MAHARASHTRA
411052
India 
Phone  7276020635  
Fax    
Email  mankarshrutee@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shruti Mankar 
Designation  Assistant Professor 
Affiliation  PES Modern College of Physiotherapy  
Address  2nd Floor,Dilkhush Bunglow, Galli No-1, Near Jijayi Garden Tapodham Parisar Warje
Department of Cardiovascular & Respiratory Physiotherapy, PES Modern College of Physiotherapy, 1186,Shivajinagar,Off.J.M.Road,Pune-411005
Pune
MAHARASHTRA
411052
India 
Phone  7276020635  
Fax    
Email  mankarshrutee@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shruti Mankar 
Designation  Assistant Professor 
Affiliation  PES Modern College of Physiotherapy  
Address  2nd Floor, Dilkhush Bunglow, Galli no 1 Near Jijayi Garden Tapodham Parisar Warje
Department of Cardiovascular & Respiratory Physiotherapy, PES Modern College of Physiotherapy, 1186,Shivajinagar,Off.J.M.Road,Pune-411005
Pune
MAHARASHTRA
411052
India 
Phone  7276020635  
Fax    
Email  mankarshrutee@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Shruti Mankar  
Address  PES Modern College of Physiotherapy JM Road Shivajinagar 
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 Shruti Mankar   Agrawal Hospital   Neuromedicine OPD, Agrawal Hospital, sai colony, 53, karve nagar rd,sramik vasahat, karve nagar, pune - 411052
Pune
MAHARASHTRA 
7276020635

mankarshrutee@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Dr.D.Y.Patil College of Physiotherapy   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G890||Central pain syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Buteyko Breathing Technique   Buteyko Breathing is a breath retraining method, taught to the patient which is to be practiced twice daily for 25-30 minutes for 6 weeks.  
Comparator Agent  Routine Pharmacological Medicine as prescribed   Participants shall receive routine medicines as prescribed by their physicians 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients Diagnosed With Migraine For At least 2 Years

Patients Who are Willing To Be A part Of This Study
 
 
ExclusionCriteria 
Details  Patient With Neurological Disease Like Head Trauma, Seizure, Encephalitis, Meningitis
Patients With Any Cardiovascular or Respiratory Conditions And Recent Abdominal Surgeries
Pregnant Females And Lactating Mothers
Patients Who Are Not Willing To Be A Part Of The Study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Heart Rate Variability
Headache Pain Intensity
Headache Frequency
Quality Of Life
Migraine Disability
 
Day 0 And At The End Of 6 Weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Sleep quality
Perceived Stress 
Day 0 And At The End Of 6 Weeks. 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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="3"
Days="30" 
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  

Migraine prevalence is notably increasing among adolescents and young adults, significantly compromising their quality of life . Headache disorders particularly migraine have very large detrimental effect on public health and productivity. One of the commonest risk factor associated with migraine are Insufficient sleep and stress. Considering the growing burden of migraine , there is a growing need for safe, non-pharmacological treatments that can complement or even reduce reliance on traditional medications. Buteyko breathing is one of the ancient breath retraining strategies used profoundly in conditions like asthma, COPD, Stress and Hypertension, is known to effective in therapeutic management of these conditions and improving the quality of life.

The Non Pharmacological Approach Buteyko Breathing could offer a low-cost, accessible, and sustainable intervention that complements conventional treatment, ultimately improving clinical outcomes and the overall well-being of individuals suffering from migraines. The study shall contain two groups, Experimental Group where Buteyko Breathing shall be taught for 6 weeks along with the routine pharmacological treatment and Control Group which shall continue to receive Pharmacological intervention as prescribed. Outcome measures like Heart Rate Variability, Headache intensity, frequency, quality of life and disability, along with Perceived Stress and Sleep quality , as they are a major risk factor for Migraine.

The results of this study could fill a crucial gap in migraine treatment options by providing evidence of a holistic approach that addresses multiple aspects of migraine, including autonomic dysfunction, stress, sleep, and quality of life.

 
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