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CTRI Number  CTRI/2019/07/020197 [Registered on: 15/07/2019] Trial Registered Prospectively
Last Modified On: 13/07/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   effects of yoga on pain, ability to do work and quality of life in young females suffering from migraine which occurs during menstruation 
Scientific Title of Study   effects of yoga on pain, disability and quality of life in young females suffering from menstrual migraine, a randomized control trial| 
Trial Acronym  a randomized control trial 
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shruti Sethiya 
Designation  masters in community physiotherapy 
Affiliation  sancheti institute college of physiotherapy 
Address  4th floor, community department, sancheti institute college of physiotherapy,11/12, thube park, shivaji nagar, pune
4th floor, community department, sancheti institute college of physiotherapy,11/12, thube park, shivaji nagar, pune
Pune
MAHARASHTRA
411005
India 
Phone  9420461622  
Fax    
Email  shrutisethiya@icloud.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Apurv Shimpi 
Designation  professor and head of community physiotherapy department 
Affiliation  sancheti institute college of physiotherapy 
Address  4th floor, community department, sancheti institute college of physiotherapy,11/12, thube park, shivaji nagar, pune
4th floor, community department, sancheti institute college of physiotherapy,11/12, thube park, shivaji nagar, pune
Pune
MAHARASHTRA
411005
India 
Phone  9890183195  
Fax    
Email  apurvshimpi@sha.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Apurv Shimpi 
Designation  professor and head of community physiotherapy department 
Affiliation  sancheti institute college of physiotherapy 
Address  4th floor, community department, sancheti institute college of physiotherapy,11/12, thube park, shivaji nagar, pune
4th floor, community department, sancheti institute college of physiotherapy,11/12, thube park, shivaji nagar, pune
Pune
MAHARASHTRA
411005
India 
Phone  9890183195  
Fax    
Email  apurvshimpi@sha.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Shruti Sethiya 
Address  11/12, thube park, shivaji nagar, pune 
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 
Shruti Sethiya  1st floor, community department, sancheti insitute college of physiotherapy   Pune, Maharashtra
Pune
MAHARASHTRA 
9420461622

shrutisethiya@icloud.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRB_SIOR/ Agenda 054  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  yoga  yoga as an intervention will be given for 8weeks , 45min per session, 2 supervised session and rest unsupervised sessions, to be performed on most days of the week 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  Women who are suffering from menstrual migraine.
Women of age 18-30 years.
Women who menstruate regularly. 
 
ExclusionCriteria 
Details  Women on OC pills.
Women who has undergone MTP in preceding 6 months.
Gravid mother, 1 year postpartum and are lactating currently. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Migraine pain scale
Migraine disability assessment
Migraine specific QOL questionnaire 
before the start of the session,at the end of 4th week, at the end of 8th week 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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)   01/08/2019 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  


Menstrual migraine is severe, lasts longer and causes associated nausea and disability, along with lowered QOL, special treatment strategies are often necessary, but however only about half of the people who suffer from migraines show clinically positive responses to medication. . As a result of these shortcomings, complimentary treatment is required to treat such conditions and as yoga exercises are considered to be an alternative medication for alleviating migraine, they can be considered as an alternative form of treatment for menstrual migraine on the basis of evidences which supports that yoga plays an important role in reducing sympathetic activity, increasing parasympathetic activity, improving QOL and decreasing leveled pain and disability in migraineurs. This study aims to find the effect of yoga on reducing the pain, disability and enhancing QOL in young women suffering from menstrual migraine using the migraine pain scale, migraine disability index, migraine specific QOL questionnaire as the assessment tools. The samples will be divided into intervention and control group. The intervention group will have to perform yoga for 8weeks, while no active intervention will be given to the control group. The participants will be assessed using the assessment tools at the beginning of the session, at the end of 4th week and at the end of 8th week. The results will then be compared using Wilcoxon Signed rank test for intra group analysis and Mann Whitney U test for the inter group analysis.

 

 

 

 
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