Study to Evaluate Efficacy, Safety and Tolerability of PENNEL Capsule in the Patients With Chronic Liver Disease

Summary

The test agent in this study is a product of biphenylmethyl dicarboxylate (BDD) with garlic oil. The two components were confirmed to have complementary effects because of different operational mechanism in animal experiments, and were examined on humans in this study. Both BDD and garlic oil are expected to show better protection and treatment on hepatotoxicity caused by toxic substances, and the purpose of this study is to confirm efficacy of and safety on human body of the agent and to determine its optimal dose.

Timeline

Start

1996-12

Primary completion

1997-05

Completion

1997-10

Outcome

Met primary endpoint

paper The proportions of patients whose ALT levels returned to normal ranges at Week 6, a primary outcome, were significantly different among 4 groups: PMID 22943930 ↗

paper The proportions were significantly higher in Groups C (p = 0.022) and D (p < 0.001) but not in Group B compared to Group A. PMID 22943930 ↗

Publications

• Lee MH, Kim YM, Kim SG. Efficacy and tolerability of diphenyl-dimethyl-dicarboxylate plus garlic oil in patients with chronic hepatitis. Int J Clin Pharmacol Ther. 2012 Nov;50(11):778-86. doi: 10.5414/CP201746.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	dimethyl-4,4'-dimethoxy-5,6,5',6'-dimethylene dioxybiphenyl-2,2'-dicarboxylate	Unknown	50 mg	Oral
Subject	dimethyl-4,4'-dimethoxy-5,6,5',6'-dimethylene dioxybiphenyl-2,2'-dicarboxylate	Unknown	75 mg	Oral
Subject	dimethyl-4,4'-dimethoxy-5,6,5',6'-dimethylene dioxybiphenyl-2,2'-dicarboxylate	Unknown	150 mg	Oral
Subject	garlic oil	Traditional medicine (herbal / TCM)	100 mg	Oral
Subject	garlic oil	Traditional medicine (herbal / TCM)	150 mg	Oral
Subject	garlic oil	Traditional medicine (herbal / TCM)	300 mg	Oral

Indications