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CTRI Number  CTRI/2024/09/074418 [Registered on: 26/09/2024] Trial Registered Prospectively
Last Modified On: 25/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Clinical And Autoantibody Profile of Patients with Systemic Sclerosis 
Scientific Title of Study   Clinical and autoantibody profile of patients of systemic sclerosis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dipak Ramesh Mokariya 
Designation  Post graduate 
Affiliation  Maulana Azad Medical College 
Address  Room no. 126, 1st floor,medicine department,BL Taneja block,MAMC,New Delhi

Central
DELHI
110002
India 
Phone  08780286745  
Fax    
Email  deepakmokariya7699@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sumeet Singla 
Designation  Professor 
Affiliation  Maulana Azad Medical College 
Address  Room no. 126, 1st floor,medicine department,BL Taneja block,MAMC,New Delhi

Central
DELHI
110002
India 
Phone  9810104431  
Fax    
Email  sumeetsingla555@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dipak Ramesh Mokariya 
Designation  Post graduate 
Affiliation  Maulana Azad Medical College 
Address  Room no. 126, 1st floor,medicine department,BL Taneja block,MAMC,New Delhi

Central
DELHI
110002
India 
Phone  08780286745  
Fax    
Email  deepakmokariya7699@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College and associated lok nayak hospital,G.I.P.M.E.R, And G.N.E.C. Hospitals, New Delhi-110002 New Delhi,Delhi  
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  Maulana Azad Medical College and associated Lok Nayak hospital,G.I.P.M.E.R and G.N.E.C Hospital ,New Delhi-110002  
Type of Sponsor  Government medical college 
 
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 Dipak Ramesh Mokariya  Lok Nayak Hospital  Maulana Azad Medical College and associated lok nayak hospital,G.I.P.M.E.R, And G.N.E.C. Hospitals, New Delhi-110002 New Delhi,Delhi
Central
DELHI 		 8780286745

deepakmokariya7699@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M349||Systemic sclerosis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients more than 12 years of age diagnosed with systemic sclerosis according to acr eular criteria of 2013 
 
ExclusionCriteria 
Details  Smokers,Pregnant patient,Patient with Diabetes meliitus,Patient with Mixed connective tissue disorer and overlap syndrome 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To determine the frequency, severity and patterns of interstitial lung disease in systemic sclerosis
To document and analysis the frequency and severity of other organ involvement in systemic sclerosis viz. cutaneous,
renal, cardiac, gastrointestinal and musculoskeletal
To study the autoantibody profile of patients of systemic sclerosis 		 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To estimate the proportion of diffuse SSc versus limited SSc patients and differences in their clinical presentation and autoantibody profile
To find out associations between clinical features and autoantibody profile in SSc patients 		 1 year 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   01/11/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [deepakmokariya7699@gmail.com].

  6. For how long will this data be available start date provided 19-09-2024 and end date provided 19-09-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Systemic sclerosis patient are at high risk of developing various organ involvement and have variety of autoimmune antibody in serum. My study would detect frequency and severity of organ involvement in systemic sclerosis patient and their correlation with antibody in patient’s serum 
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