Clinical Trial: Silymarin for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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-Alcoholi
Brief 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 Summary:
OBJECTIVES OF STUDY Primary Objectives
- To assess the safety and adverse event profile of Silymarin compared to placebo.
- 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
- To compare NAS activity before and after Silymarin therapy.
- To characterize changes in ALT and AST during Silymarin therapy.
- To compare insulin resistance measured by HOMAr during Silymarin therapy.
Sponsor: University of Malaya
Current Primary Outcome: 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 [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: To assess the safety and adverse event profile of Silymarin compared to placebo [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: University of Malaya
Dates:
Date Received: December 4, 2013
Date Started: June 2012
Date Completion:
Last Updated: January 6, 2016
Last Verified: January 2016
