Silymarin for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title: A Randomised, Double-blind, Placebo-controlled, Phase II, Single-centre Study to Assess the Safety and Efficacy of Silymarin 700 mg Capsules TID for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)

Status Completed

Clinical Trial Summary

This is a randomised study to examine whether high dose Sillymarin will be able to help improve fat-induced liver damage in the liver. The study hypothesis is that high dose Sillymarin will be able to reduce steato-hepatitis (fat-related liver inflammation) better than placebo.

Clinical Trial Description

OBJECTIVES OF STUDY Primary Objectives

1. To assess the safety and adverse event profile of Silymarin compared to placebo.

2. To assess the efficacy of Silymarin as defined by an improvement in non-alcoholic steatosis (NAS) activity score by at least 30% from baseline compared to placebo.

Secondary Objectives

1. To compare NAS activity before and after Silymarin therapy.

2. To characterize changes in ALT and AST during Silymarin therapy.

3. To compare insulin resistance measured by HOMAr during Silymarin therapy. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

• NCT number: NCT02006498
• Study type: Interventional
• Source: University of Malaya
• Status: Completed
• Phase: Phase 2
• Start date: June 2012
• Completion date: December 2015