Phase II Trial of Silymarin for Patients With Chronic Hepatitis C Who Have Failed Conventional Antiviral Treatment
Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
Summary
Silymarin (Legalon), 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).
Eligible subjects will be randomized to treatment with placebo or one of two dosages of
Legalon® 420 mg or 700 mg administered orally thrice daily. Investigators and subjects will
be masked to treatment assignment. The study design includes a screening period during which
patients will undergo full medical evaluation to verify protocol eligibility and a treatment
period of 24 weeks during which time clinic visits and laboratory studies will be performed
every 2-4 weeks to monitor for safety and efficacy of therapy. Subjects will continue to be
followed for an additional 12 weeks after the completion of study medication to monitor for
adverse events and investigate post-treatment outcomes. Participation in this research study
requires the subject to travel to the clinic for at least 10 visits so recruitment will be
limited to a geographically restricted area around participating clinical centers.
Phase:
Phase 2
Details
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Collaborators:
Beth Israel Deaconess Medical Center National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Thomas Jefferson University University of North Carolina, Chapel Hill University of Pennsylvania University of Pittsburgh