Phase II Trial of Silymarin for Non-Cirrhotic Patients With Non-Alcoholic Steatohepatitis
Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
Summary
Silymarin, also known as milk thistle, is an alternative medicine commonly found in health
food and vitamin stores. People with liver disease sometimes use silymarin because it is
thought to have liver protecting effects; however, this benefit has not been proven. The
purpose of this research study is to determine the effectiveness of silymarin and assess the
safety of different silymarin doses in patients with varying severity of liver disease
compared to a placebo (lactose pill).
Following a screening visit, patients with histologically confirmed NASH will be randomized
to either placebo or one of two active treatment groups of silymarin (Legalon®). One active
treatment group will receive 420 mg, each dose given three times daily, the other active
treatment group will receive 700 mg, each dose given three times daily. Patients will be
treated for 48-50 weeks. Participation in this research study requires the patient to travel
to the clinic for at least 11 visits so recruitment will be limited to a geographically
restricted area around participating clinical centers. Liver biopsy must be performed up to
12 months prior to, and immediately after, the treatment phase.
Phase:
Phase 2
Details
Lead Sponsor:
Madaus Inc
Collaborators:
Beth Israel Deaconess Medical Center Brooke Army Medical Center Thomas Jefferson University University of North Carolina University of Pennsylvania University of Pittsburgh