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
|
|
Primary Sponsor
|
Name |
Shruti Sethiya |
Address |
11/12, thube park, shivaji nagar, pune |
Type of Sponsor |
Other [self] |
|
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 |
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
|
|
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. |