| CTRI Number |
CTRI/2024/01/061701 [Registered on: 22/01/2024] Trial Registered Prospectively |
| Last Modified On: |
19/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy and safety of saroglitazar and Vitamin E In Non alcoholic fatty liver related chronic liver disease. |
|
Scientific Title of Study
|
Efficacy and Safety of Saroglitazar and Vitamin E in NAFLD Related Compensated Advanced Chronic Liver Disease. |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ganesh C P |
| Designation |
Senior Resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
Room No.36, Department of Hepatology, PGIMER Chandigarh Sector 12 Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09884214626 |
| Fax |
|
| Email |
ganesh4joy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ajay Duseja |
| Designation |
Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Room No.36, Department of Hepatology, PGIMER Chandigarh Sector 12 Chandigarh.
Chandigarh
CHANDIGARH
160011
India |
| Phone |
9884214626 |
| Fax |
|
| Email |
hepatologyhod@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
GANESH C P |
| Designation |
Senior Resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
Room No.36, Department of Hepatology, PGIMER Chandigarh Sector 12 Chandigarh.
Chandigarh
CHANDIGARH
160011
India |
| Phone |
09884214626 |
| Fax |
|
| Email |
ganesh4joy@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Room No.36, Department of Hepatology, PGIMER Chandigarh Sector 12 Chandigarh. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ganesh CP |
PGIMER |
Room No.36, Department of Hepatology, PGIMER Chandigarh Sector 12 Chandigarh.
Chandigarh
CHANDIGARH |
9884214626
ganesh4joy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER CHANDIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K740||Hepatic fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Saroglitazor
4mg OD for 6 months
|
Saroglitazor has been widely used in treatment of NAFLD with high fibrosis and for dyslipidemic diabetics so we are comparing it with vit E in cACLD group |
| Comparator Agent |
Vitamin E
400IU BD for 6 months |
Vitamin E has been widely used in treatment of NAFLD with high fibrosis, so we are comparing it with saroglitazor in cACLD group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
75.00 Day(s) |
| Gender |
Both |
| Details |
1. Age18-75years
2. Patients with NAFLD: Defined by the presence of hepatic steatosis on ultrasound or using CAP parameters (of FibroScan) in absence significant consumption of alcohol (<20g/day irrespective of gender) after ruling out other etiologies for hepatic steatosis or elevated transaminases including but not limited to chronic viral hepatitis, autoimmune Hepatitis, hemochromatosis, Wilson disease, celiac disease, Drug induced liver injury (DILI), etc.
3. Patients with LSM> 10kPa
4. Consent to participate in study
|
|
| ExclusionCriteria |
| Details |
1. Patients <18years of age
2. Patients with Hepatic decompensation
3. Patients with HCC or any other malignancy
4. Patients with concomitant other aetiologies for hepatic steatosis/fibrosis or elevated transaminases
5. Patients already on Vitamin E or pioglitazone
6. Pregnancy/Lactation and those non pregnant female patients recruited in the study who will conceive during the study period will be excluded from the study.
7. Patients who are too sick to conduct the protocol.
8. Those who do not consent to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcomes:
Improvement in the hepatic fibrosis in patients with NAFLD related compensated advanced chronic liver disease at the end of 6 months.
|
Primary Outcomes:
Improvement in the hepatic fibrosis in patients with NAFLD related compensated advanced chronic liver disease at the end of 6 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Hepatic fat fraction
Improvement in MRE
Improvement in FAST and MAST scores
Improvemnt in ALT
Improvement in Agaile 3+ and Agile 4 score |
at the end of 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
15/02/2024 |
| 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="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
|
NAFLD emerging as the most common liver disease in the modern era. Though obesity is a prominent cause of NAFLD, it is also observed in patients in prediabetic and patient with metabolic risk factors. Interventions resulting in weight loss has a prominent role in treatment of NAFLD. Saroglitazar is a DGCI approved drug for the treatment of NAFLD by pharmacotherapy. Saroglitazar may have beneficial role in NAFLD with cACLD. No studies have analyzed the role of pharmacotherapy in Pre-diabetic NAFLD this study will also give insight about various MRI parameters for detection of significant fibrosis in NAFLD. We will conduct this study to look for the safety and efficacy of Saroglitazar in the treatment of NAFLD patients with cACLD |