| CTRI Number |
CTRI/2024/03/063735 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Saroglitazar in Non alcoholic fatty liver disease |
|
Scientific Title of Study
|
Effect of Saroglitazar on hepatic steatosis in non-alcoholic fatty liver disease patients: a randomised double blind placebo controlled trial |
| Trial Acronym |
NAFLD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Harsha |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Pharmacology
All India Institute of Medical Sciences, Phulwarisharif, Patna
Department of Pharmacology,
All India Institute of Medical Sciences, Phulwarisharif
Patna
BIHAR
801507
India |
| Phone |
7903799905 |
| Fax |
|
| Email |
divya12345.dd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Maharshi |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Pharmacology
All India Institute of Medical Sciences, Phulwarisharif, Patna
Department of Pharmacology
All India Institute of Medical Sciences, Phulwarisharif
Patna
BIHAR
801507
India |
| Phone |
8368035562 |
| Fax |
|
| Email |
divya12345.dd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Harsha |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Pharmacology,
All India Institute of Medical Sciences, Phulwarisharif, Patna
Department of Pharmacology,
All India Institute of Medical Sciences, Phulwarisharif
Patna
BIHAR
801507
India |
| Phone |
7903799905 |
| Fax |
|
| Email |
divya12345.dd@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Phulwarisharif, Patna |
|
|
Primary Sponsor
|
| Name |
No sponsor |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable ] |
|
|
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 |
| Dr Divya Harsha |
All India Institute of Medical Sciences, Patna |
Department of Gastroenterology,
All India Institute of Medical Sciences
Patna
BIHAR |
7903799905
divya12345.dd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K77||Liver disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Placebo once daily for 6 months |
| Intervention |
Saroglitazar |
Tab. Saroglitazar 4mg Once a day for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
i) Age -18-60 years
ii) Either of the gender (Male and female)
iii)Evidence of fatty liver on USG
iv) Patient’s willingness to comply with the study protocol and prior written informed consent |
|
| ExclusionCriteria |
| Details |
1)Alcoholics for past 6 months
2)Patients with type i or type 2 diabetes mellitus
3) Patients with alternate causes of fatty liver including:
-Patients on TPN and those who underwent surgical procedures within 90 days
from randomization
-presence of other chronic liver disease such as hepatitis B or C, liver
cirrhosis, Wilson’s disease or any other autoimmune condition leading to fatty liver
4) Use of drugs with potential effect on NASH such as: Ursodeoxycholic acid, SAdenosyl Methionine(SAM-e), Betaine, Pentoxyfylline, Obeticholic acid, milk thistle, Vitamin E, statins, CYP3C8 inhibitors or substrate -within 3 months before visit 1
5) Presence of bleeding disorders, myopathy, malignancy, hypothyroidism
6) Presence of anaemia, acute or chronic kidney disease, acute or chronic liver disease
7) Participation in other NAFLD/NASH related study within last 3 months
8) Pregnant or lactating females or couples planning pregnancy within 3 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change from baseline in CAP values on Fibroscan |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change from baseline in serum alanine amino transferase values |
24 weeks |
| Mean change from baseline in lipid profile |
24 weeks |
| Mean change from baseline in FBS, HbA1c, HOMA-IR |
24 weeks |
| Mean change from baseline in BMI, body weight, Waist-Hip ratio |
24 weeks |
| Mean change in LSM values from baseline |
24 weeks |
| Mean change in FIB-4 score |
24 weeks |
| Mean change in Hepatic steatosis index |
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "139"
Final Enrollment numbers achieved (India)="139" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/03/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
There is currently no guideline on Pharmacotherapy of NAFLD in non diabetic patients, one retrospective observational study has been conducted but no clinical trials for use of Saroglitazar in non diabetic non alcoholic patient is available hence this study will generate evidence for the use of Saroglitazar in non diabetic NAFLD patients ⦠Saroglitazar in a drug approved for diabetic dyslipidemia and there are clinical trials which have shown the efficacy on NAFLD in patients with diabetic dyslipidemia |