| CTRI Number |
CTRI/2024/08/071952 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on the relation between platelets and liver enzymes with Liver fibroscan to find the severity of liver disease in patients who have non alcoholic fatty liver disease |
|
Scientific Title of Study
|
Association of APRI,FIB-4,AST/ALT with Fibroscan in Patients of Non Alcoholic Fatty Liver Disease for assesing Hepatic Fibrosis |
| 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.Nannaka Vikas |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College and Hospital manipal |
| Address |
Department of General Medicine, kasturba medical college , madhav nagar Manipal ,Udupi district,karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9640065306 |
| Fax |
|
| Email |
nannaka.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Shubhada |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical College and Hospital Manipal |
| Address |
Department of General Medicine, Kasturba medical College ,Madhav Nagar Manipal,Udupi district, Karnataka state,India
Udupi
KARNATAKA
576104
India |
| Phone |
9844465447 |
| Fax |
|
| Email |
Shubhada.u@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Shubhada |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College and Hospital Manipal |
| Address |
Department of General Medicine
Kasturba Medical College ,Madhav Nagar Manipal,Udupi district,Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9844465447 |
| Fax |
|
| Email |
Shubhada.u@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of General Medicine Kasturba Medical College and Hospital madhav nagar Manipal,Udupi district,karnataka state ,India
Pincode:576104 |
|
|
Primary Sponsor
|
| Name |
Department of general medicine |
| Address |
Kasturba Medical College and Hospital Madhav Nagar, Manipa,Udupi district,Karnataka state,India
PIN code:576104 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of medical gastroenterology |
Kasturba medical college madhav nagar Manipal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrNannaka vikas |
KASTURBA HOSPITAL MANIPAL |
Department of General Medicine, Kasturba Medical College and Hospital, Madhav nagar,manipal,Udupi district, Karnataka state,India
Pincode 576104
Udupi
KARNATAKA |
9640065396
nannaka.kmcmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba Hospital Institutional Ethics committee-Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are diagnosed having NAFLD and NASH , undergoing fibrous scan in kasturba hospital Manipal |
|
| ExclusionCriteria |
| Details |
Hepatitis B, hepatitis C, auto immune hepatitis, ITP ,history of herbal medication use, history of inherited jaundice |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Find out association of APRI,FIB-4,AST/ALT ration with fibroscan and using it for assessing hepatic fibrosis |
Cross sectional study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find which score among these have better association with fibroscan |
Cross sectional study |
|
|
Target Sample Size
|
Total Sample Size="113"
Sample Size from India="113"
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)
|
15/08/2024 |
| 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="6"
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
|
The study will recruit the patients of NAFLD who have underwent fibroscan and cbc,Lft in the a duration of one month both from op and IP of general medicine and medical gastroenterology And APRI,FIB-4,AST/ALT ratio will be calculated and is used to find association with fibroscan in assessing hepatic fibrosis |