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CTRI Number  CTRI/2024/10/075627 [Registered on: 22/10/2024] Trial Registered Prospectively
Last Modified On: 25/10/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   The correlation between clinical profile, metabolic profile, laboratory profile and Fibroscan in MASLD- A real world experience 
Scientific Title of Study   The correlation between anthropometry, metabolic profile, laboratory profile, non invasive tests and Fibroscan in MASLD- Metabolic Dysfunction Associated Steatotic Liver Disease: A real world experience 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mhasisielie Zumu 
Designation  Registrar Medical Gastroenterology, Madras Medical Mission Hospital Chennai  
Affiliation  Madras Medical Mission Hospital  
Address  IGLD Dept, Madras Medical Mission Hospital, JJ Nagar , East Mogappair, Chennai, Tamil Nadu

Chennai
TAMIL NADU
600037
India 
Phone  9612499310  
Fax    
Email  asizumu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mhasisielie Zumu 
Designation  Registrar Medical Gastroenterology, Madras Medical Mission Hospital Chennai  
Affiliation  Madras Medical Mission Hospital  
Address  IGLD Dept, Madras Medical Mission Hospital, JJ Nagar , East Mogappair, Chennai, Tamil Nadu

Chennai
TAMIL NADU
600037
India 
Phone  9612499310  
Fax    
Email  asizumu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mhasisielie Zumu 
Designation  Registrar Medical Gastroenterology, Madras Medical Mission Hospital Chennai  
Affiliation  Madras Medical Mission Hospital  
Address  IGLD Dept, Madras Medical Mission Hospital, JJ Nagar , East Mogappair, Chennai, Tamil Nadu

Chennai
TAMIL NADU
600037
India 
Phone  9612499310  
Fax    
Email  asizumu@gmail.com  
 
Source of Monetary or Material Support  
Madras Medical Mission Hospital Chennai, Tamil Nadu, India- 600037 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 Mhasisielie Zumu  Madras Medical Mission Hospital  IGLD Dept, Madras Medical Mission Hospital, JJ Nagar , East Mogappair, Chennai, Tamil Nadu
Chennai
TAMIL NADU 		 09612499310

asizumu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, The Madras Medical Mission   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K768||Other specified diseases of liver,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  •Willingness to give consent and follow up
•Fulfilling the criteria for MASLD
•Patients with followup records available, with atleast one visit during the study period
 
 
ExclusionCriteria 
Details  •Cirrhosis patients
•Decompensated chronic Liver disease
•Pregnancy
•Chronic viral hepatitis Infections
•Hypotension/ shock
•History of CAM intake
•History of Hepatotoxic drug used in the last 3 months
•Alcohol Used disorder
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)To compare and correlate Non Invasive test and score – FIB 4/APRI/AST/ALT ratio /NFS with Fibroscan values – CAP /LSM
2)To compare and correlate anthropometry measurements with Fibroscan values – CAP /LSM
3)To compare the non Invasive tests- FIB 4/APRI/AST/ALT ratio /NFS and Fibroscan, pre and post treatment (after 6 months of standrard therapy).

 		 8 months  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)
Modification(s)  		 26/10/2024 
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="0"
Months="8"
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 - NO
Brief Summary   A systemic review and meta‑analysis by Shalimar et al. showed that pooled prevalence was 38.6% in adults and pooled prevalence was 35.4% in children. A systemic review and meta‑analysis by Shalimar et al. showed that pooled prevalence was 38.6% in adults and pooled prevalence was 35.4% in children. A systemic review and meta‑analysis by Shalimar et al. showed that pooled prevalence was 38.6% in adults and pooled prevalence was 35.4% in children. De Silva S, et al, performed a retrospective study on patients with histologically confirmed NAFLD,  showed that blood test-based non-invasive scores are less accurate in South Asian patients, irrespective of metabolic parameters. (population- younger, had lower body mass index) however Transient elastography was equally and highly accurate in both ethnicities. Mathew et al. - retrospective observational analytical study of patients who had a liver biopsy with a diagnosis of NAFLD, in south India- NFS of >0.676 had a sensitivity of 68% and specificity of 100%, and an FIB-4 index of >2.67 had a sensitivity of 67% and specificity of 95.6 % in diagnosing Advance fibrosis. Ornelas et al. -The total accuracy of the Fibroscan was found to be 66% (21 “good” correlation, 11 “poor” correlation). The accuracy of non-alcoholic steatohepatitis (NASH) was 91% compared to 52% for non-NASH liver diseases. Spearman rank correlation between Fibroscan and liver biopsy in NASH patients was found to be both positive and significant (Spearman’s correlation  0.699, P  0.017).  
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