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CTRI Number  CTRI/2023/06/054027 [Registered on: 16/06/2023] Trial Registered Prospectively
Last Modified On: 12/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Problems in Musculoskeletal system in Women After Menopause  
Scientific Title of Study   Musculoskeletal Disorders in Postmenopausal Women  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priyal shah 
Designation  PG student  
Affiliation  College of physiotherapy, Sumandeep Vidhyapeeth An Institute Deemed To Be University  
Address  PG Classroom, On Ground Floor, College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At And Post Pipariya, Taluka-Waghodia, Vadodara Gujarat
PG Classroom, On Ground Floor, College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At And Post Pipariya, Taluka-Waghodia, Vadodara Gujarat
Vadodara
GUJARAT
391760
India 
Phone  9426490550  
Fax    
Email  priyalshah504@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrNeha Mukkamala 
Designation  Associate Professor  
Affiliation  College of physiotherapy, Sumandeep Vidhyapeeth An Institute Deemed To Be University  
Address  Staff room,On Ground Floor, College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At And Post Pipariya, Taluka-Waghodia, Vadodara Gujarat
Staff room, On Ground Floor, College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At And Post Pipariya, Taluka-Waghodia, Vadodara Gujarat
Vadodara
GUJARAT
391760
India 
Phone  9898216184  
Fax    
Email  neha.cop@sumandeepvidyapeethdu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Priyal shah 
Designation  PG student  
Affiliation  College of physiotherapy, Sumandeep Vidhyapeeth An Institute Deemed To Be University  
Address  PG Classroom, On Ground Floor, College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At And Post Pipariya, Taluka-Waghodia, Vadodara Gujarat
PG Classroom, On Ground Floor, College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At And Post Pipariya, Taluka-Waghodia, Vadodara Gujarat
Vadodara
GUJARAT
391760
India 
Phone  9426490550  
Fax    
Email  priyalshah504@gmail.com  
 
Source of Monetary or Material Support  
This is a self funded study. The infrastructure is provided is by college of physiotherapy, sumandeep vidhyapeeth, An institutional deemend to be university vadodara gujarat 
 
Primary Sponsor  
Name  Priyal Shah 
Address  PG Classroom, On Ground Floor, College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At And Post Pipariya, Taluka-Waghodia, Vadodara Gujarat 
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 
Priyal Shah  Dhiraj general hospital  1st floor,Gynecology department Dhiraj general hospital sumandeep vidhyapeeth pipariya vadodara gujarat
Vadodara
GUJARAT 
9426490550

priyalshah504@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Dhiraj hospital   No Objection Certificate 
Sumandeep vidyapeeth Institutional Ethics Committee (SVIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  postmenopausal women 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  All postmenopausal women (menopause for > 1 year) 
 
ExclusionCriteria 
Details  1.women with unnatural menopause
2.women on medication such as anxiolytic and antidepresaant
3.women having mental retardation
4.women diagnosed with neurological disorders, metabolic disorders.
5.women diagnosed with malignancy
6.women hving musculoskeletal pain prior to menopause 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
cornell musculoskeletal discomfort questtionaire  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="95"
Sample Size from India="95" 
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)   30/06/2023 
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    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a observational study. In my study the postmenopausal women including in my inclusion criteria will be asseed and screened for the different musculoskeletal disorder. All the womens will be explained about the study in their own languge. They will be administered using cornell musculoskeletal discomfort questionnaire. Depending on the joint involvement they will be assesed in detail. 
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