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CTRI Number  CTRI/2021/02/031007 [Registered on: 04/02/2021] Trial Registered Prospectively
Last Modified On: 02/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Yoga for migraine  
Scientific Title of Study   Effect of yoga protocol on migraine: a randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashwini Ghanshyam Pawar 
Designation  MD scholar  
Affiliation  Swami vivekananda yoga anusandana samantha  
Address  Swami vivekananda yoga anusandhana samsthanm Swami Vivekananda Road Kalluballu Post Anekal Jigani Karnataka 560105 Bangalore KARNATAKA 560105 India

Bangalore
KARNATAKA
560105
India 
Phone  8779486291  
Fax    
Email  ashu.parmar27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dhrithi Reddy  
Designation  Assistant professor  
Affiliation  Swami vivekananda yoga anusandana samantha(s-vyasa) 
Address  Swami vivekananda yoga anusandhana samsthanm Swami Vivekananda Road, Kalluballu Post Anekal Jigani Karnataka 560105 Bangalore KARNATAKA 560105 India

Bangalore
KARNATAKA
560105
India 
Phone  9482319833  
Fax    
Email  dhrithibreddy@svyasa.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Dhrithi Reddy  
Designation  Assistant professor  
Affiliation  Swami vivekananda yoga anusandana samantha(s-vyasa) 
Address  Swami vivekananda yoga anusandhana samsthanm Swami Vivekananda Road, Kalluballu Post Anekal Jigani Karnataka 560105 Bangalore KARNATAKA 560105 India

Bangalore
KARNATAKA
560105
India 
Phone  9482319833  
Fax    
Email  dhrithibreddy@svyasa.edu.in  
 
Source of Monetary or Material Support  
Department of yoga and life science, Swami Vivekananda Yoga Anusandhana Samsthana , Kalluballu Post, Anekal, Jigani, Bangalore, KARNATAKA, 560105 India 
 
Primary Sponsor  
Name  Swami Vivekananda Yoga Anusandhana Samsthana 
Address  Swami Vivekananda Yoga Anusandhana Samsthana Kalluballu Post Anekal Jigani Karnataka 560105 
Type of Sponsor  Other [[Swami Vivekananda Yoga Anusandhana Samsthana]] 
 
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 Ashwini Pawar   Vimal netralaya and phaco center   Ophthalmic department, room number 2, prabhakar bhavan, gavhane road pbn.
Parbhani
MAHARASHTRA 		 8779486291

ashu.parmar27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee SVYASA Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G439||Migraine, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard conventional treatment  Participants in the control group will follow their daily routine and standard conventional treatment protocol prescribed by their physician . After1 month of intervention period they would be invited for yoga practices. 
Intervention  Integrated yoga module   This research involves yoga module as an intervention. Yoga module involves loosening, stretching, breathing exercises, pranayama, Kapalabhathi and cyclic meditation. This intervention will be provided for 5days/week for month. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Diagnosed migraine patients who are willing to participate in the study, age group 18 to 45 years male and female, with or without medication are included.  
 
ExclusionCriteria 
Details  Those who are having other systemic diseases, Unstable medical and psychiatric conditions, pregnant and lactating women, patients who are taking other treatment are excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Functional ability on job, at school, at home and in social situations, level of pain.
 		 Headache impact test six Score (HIT)6 before and after one month intervention.
 
 
Secondary Outcome  
Outcome  TimePoints 
Impact of headaches on life and the level of pain, disability caused by headaches, find the best treatment.  Migraine disability assessment (MIDAS) score before and after one month intervention.
 
 
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)   09/02/2021 
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="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Migraine is a common neurological disorder leading to significant disability. The conventional management of migraine includes taking preventive medications. Limited studies on yoga in migraine indicate a positive benefit of use of yoga in management of migraine. However, there is a lack of clinical trials to generalize the effects of yoga. Thus, such study is warranted.    
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