Silymarin, the active ingredient in milk thistle, has been in longstanding use as an anti-oxidant and hepatoprotective agent but has not been rigorously evaluated in clinical trials for liver disease. This phase II multiple arm placebo controlled randomized clinical trial will assess the safety and efficacy of a standardized orally administered silymarin preparation for treating two groups of patients:
- patients with chronic hepatitis C virus (HCV) who failed conventional antiviral therapy
- patients with non-alcoholic steatohepatitis (NASH)
Participants will be randomized to treatment with placebo or one of two dosages of silymarin administered orally three times per day. Patients with HCV will undergo treatment for 6 months with a goal to achieve reduction in liver enzyme levels whereas patients with NASH will undergo liver biopsies prior to and following 1 year of therapy, with the goal of reducing the NASH activity score (NAS).
