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CTRI Number  CTRI/2022/07/044146 [Registered on: 19/07/2022] Trial Registered Prospectively
Last Modified On: 15/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Clinical features of fatty liver in non alcoholic and its association with obesity, type 2 diabetes 
Scientific Title of Study   Study of clinical profile of Non alcoholic fatty liver disease/Non alcoholic steatohepatitis and its association with metabolic syndrome 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Basavesh Gongadashetti 
Designation  Resident 
Affiliation  D.Y. Patil School of Medicine, Navi Mumbai 
Address  3rd floor Department of Geneal Medicine DR D Y Patil School Of Medicine Sector 7 Nerul
Dr D Y Patil School Of Medicine Sector 7 Nerul
Thane
MAHARASHTRA
400706
India 
Phone  9900488521  
Fax    
Email  sgbasavesh114@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Basavesh Gongadashetti 
Designation  Resident 
Affiliation  D.Y. Patil School of Medicine, Navi Mumbai 
Address  3rd floor Department of General Medicine DR D Y Patil School Of Medicine Sector 7 Nerul
Dr D Y Patil School Of Medicine Sector 7 Nerul
Thane
MAHARASHTRA
400706
India 
Phone  9900488521  
Fax    
Email  sgbasavesh114@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Smita Patil 
Designation  Professor 
Affiliation  Dr. D. Y. Patil Hospital and Deemed to be University 
Address  Department Of General Medicine Dr D Y Patil Hospital Sector 7 Nerul
Dr D Y Patil Hospital Sector 7 Nerul
Thane
MAHARASHTRA
400706
India 
Phone  9821027742  
Fax    
Email  smita.patil@dypatil.edu  
 
Source of Monetary or Material Support  
Dr D Y Patil hospital School Of Medicine 
 
Primary Sponsor  
Name  DR Basavesh Gongadashetti 
Address  3rd floor Department of General Medicine Dr D Y Patil School Of Medicine Sector 7 Nerul 
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 
Dr Basavesh Gongadashetti  D.Y. Patil Hospital  3rd Floor Department Of General Medicine Dr D Y Patil Hospital Sector 7 Nerul
Thane
MAHARASHTRA 		 9900488521

sgbasavesh114@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E888||Other specified metabolic disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1 All patients diagnosed as NASH/NAFLD by abdominal 2 ultrasonography and blood investigations
3 Patients giving consent for the study
Age>18years 
 
ExclusionCriteria 
Details  1 Patients with history of alcohol intake more than 30grams/day in males and more than 20grams/day
2 Patients with any other chronic illness
3 Patients not giving consent for the study
4 Patients<18years 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Association of NASH/NAFLD with metabolic syndrome  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Cirrhosis in NASH/NAFLD patients   Duration of hospital stay or till in hospital death 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   20/07/2022 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
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-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sgbasavesh114@gmail.com].

  6. For how long will this data be available start date provided 30-11-2022 and end date provided 30-11-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The present study is the clinical observational study for completion under Dr D Y Patil School Of Medicine Deemed to be University
Total duration of trial 1 year


TITLE: Study Of Clinical Feature Of NASH/NAFLD and its Association with Metabolic Syndrome


STUDY GROUP: Sample Size 30


Study Centre: School of Medicine Dr D Y PTIL deemed to be University and Hospital, Nerul, Navimumbai

 
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