NCT02006498

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: University of Malaya · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Non-alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	Sillymarin	Sillymarin is derived from the milk thistle plant, Silybum marianum, a herbal remedy that has been used for centuries for diseases of the liver. It is a complex mixture of 6 major flavonolignans (silybins A and B, isosilybins A and B, silychristin, and silydianin), as well as other minor polyphenolic compounds.
DRUG	Placebo	Placebo capsule with same appearances as study drug

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-12-10
• Last updated: 2016-01-08

Locations

1 site across 1 country: Malaysia