Phase I Trial of Silymarin for Chronic Liver Diseases

Summary

The purpose of this study is to determine the safety and tolerability of different dosages of silymarin on subjects with Hepatitis C or Non-Alcoholic Fatty Liver Disease.

Conditions

• Hepatitis C
• Non-Alcoholic Fatty Liver Disease

Interventions

DRUG

Placebo

Placebo

DRUG

Silymarin

140 mg every 8 hours

DRUG

Silymarin

280 mg single dose

DRUG

Silymarin

280 mg single dose + every 8 hours

DRUG

Silymarin

560 mg single dose + every 8 hours

DRUG

Silymarin

560 mg single dose + every 8 hours

DRUG

Silymarin

280 mg every 8 hours

DRUG

Silymarin

700 mg single dose + every 8 hours

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• National Center for Complementary and Integrative Health (NCCIH)

  lead NIH

Principal Investigators

• K. Rajender Reddy, MD · University of Pennsylvania

• Victor Navarro, MD · Thomas Jefferson University

• Nezam Afdhal, MD · Beth Israel Deaconess Medical Center

• Michael Fried, MD · University of North Carolina

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-11-30

Primary Completion

2008-01-31

Completion

2008-02-29

Countries

• United States

Study Locations