Overview

Role of Obeticholic Acid in the Patients of NAFLD With Raised ALT

Status:
Recruiting

Trial end date:
2020-12-01

Target enrollment:
0

Participant gender:
All

Summary

This study will be conducted upon the patients with fatty liver disease. Patients who will be diagnosed as a case of fatty liver disease by ultrasound with raised liver enzyme (ALT) will be primarily selected for the study. A total number of 70 patients will be randomly selected for the study that will also be divided into two groups for the study purpose. The patients will be informed about the details of the study. After getting the detail information those who will give informed written consent will be finally included in the study. One group of patients will be treated by both life style modification and Obeticholic acid. Another group of patients by only life style modification. After 3 months of treatment the two groups will be compared of improvement of fatty liver disease and liver enzyme by improvement of fibroscan with CAP value as well as improvement of ALT value.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sir Salimullah Medical College Mitford Hospital

Treatments:

Chenodeoxycholic Acid

Criteria

Inclusion Criteria:

- NAFLD (by USG)

- Raised ALT (>40 U/L)

Exclusion Criteria:

- Patient with significant alcohol intake (more than 20 gm/day).

- Patient with history of taking drugs that may cause fatty liver (i.e. tamoxifen,
valproic acid, amiodarone, methotrexate, steroid, OCP) or history of taking drugs that
have shown benefit in previous NASH pilot studies (i.e. vitamin E, metformin,
thiazolidinediones, statin, ARB, fibrates, DPP-4 inhibitor, Omega-3 fatty acid).

- Chronic viral hepatitis (HBV, HCV).

- Pregnancy

- Patient with co-morbid condition (COPD, CKD, CCF etc.)

- Patient with history of recent MI

- Patient with liver failure

- Patient with hypothyroidism