Phase I Trial of Silymarin for Chronic Liver Diseases

Phase 1

Completed

• Conditions: Hepatitis C; Non-Alcoholic Fatty Liver Disease
• Interventions: Drug: Placebo; Drug: Silymarin

• Registration Number: NCT00389376
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-10-16
• Study First Submitted QC: 2006-10-16
• Study First Posted: 2006-10-18
• Study Start: 2006-11
• Primary Completion: 2008-01
• Status Verified: 2008-02
• Study Completion: 2008-02
• Last Update Submitted: 2008-02-15
• Last Update Posted: 2008-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Placebo	Placebo and 140 mg single dose + every 8 hours
Group 3	Placebo	Placebo and 280mg every 8 hours
Group 1	Silymarin	Placebo and 140 mg single dose + every 8 hours
Group 2	Placebo	Placebo and 280 mg single dose
Group 4	Placebo	Placebo and 280 single dose + every 8 hours
Group 5	Placebo	Placebo and 560 mg single dose + every 8 hours
Group 6	Placebo	Placebo and 560 mg single dose + every 8 hours
Group 6	Silymarin	Placebo and 560 mg single dose + every 8 hours
Group 7	Placebo	Placebo and 700 mg single dose + every 8 hours
Group 7	Silymarin	Placebo and 700 mg single dose + every 8 hours
Group 2	Silymarin	Placebo and 280 mg single dose
Group 3	Silymarin	Placebo and 280mg every 8 hours
Group 4	Silymarin	Placebo and 280 single dose + every 8 hours
Group 5	Silymarin	Placebo and 560 mg single dose + every 8 hours

Primary Outcome Measures

Name	Time	Method
Adverse events	10 days

Trial Locations

Locations (5)

The University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburgh, Graduate School of Public Health; 🇺🇸 Pittsburgh, Pennsylvania, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States