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

NCT03836937 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-05-17

No results posted yet for this study

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.

Conditions

  • Non-Alcoholic Fatty Liver Disease

Interventions

DRUG

Obeticholic acid

Farnesoid X receptor ligand which is a semi synthetic bile acid analogue

Sponsors & Collaborators

  • Sir Salimullah Medical College Mitford Hospital

    lead OTHER_GOV

Principal Investigators

  • Md F Karim, MBBS,FCPS,MD · Sir Salimullah Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-05
Primary Completion
2020-11-30
Completion
2021-12-31

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03836937 on ClinicalTrials.gov