NCT00389376

Phase I Trial of Silymarin for Chronic Liver Diseases

Single and Multiple Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered Silymarin (Legalon) in Non-Cirrhotic Subjects With Chronic Hepatitis C or Non-Alcoholic Fatty Liver Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: National Center for Complementary and Integrative Health (NCCIH) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-01-01
• Completion: 2008-02-01
• First posted: 2006-10-18
• Last updated: 2008-02-20

Locations

5 sites across 1 country: United States