drugset

drugset / Trial / NCT00389376

Phase I Trial of Silymarin for Chronic Liver Diseases

NCT00389376 ↗

Phase 1 Completed 56 enrolled National Center for Complementary and Integrative Health (NCCIH) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab

RandomizedParallel-groupTriple-blindBasic science

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.

Timeline

Start: 2006-11
Primary completion: 2008-01
Completion: 2008-02

Publications

Schrieber SJ, Hawke RL, Wen Z, Smith PC, Reddy KR, Wahed AS, Belle SH, Afdhal NH, Navarro VJ, Meyers CM, Doo E, Fried MW. Differences in the disposition of silymarin between patients with nonalcoholic fatty liver disease and chronic hepatitis C. Drug Metab Dispos. 2011 Dec;39(12):2182-90. doi: 10.1124/dmd.111.040212. Epub 2011 Aug 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Silymarin	Traditional medicine (herbal / TCM)	140 mg	Oral
Subject	Silymarin	Traditional medicine (herbal / TCM)	280 mg	Oral
Subject	Silymarin	Traditional medicine (herbal / TCM)	560 mg	Oral
Subject	Silymarin	Traditional medicine (herbal / TCM)	700 mg	Oral

Indications