drugset / Trial / NCT01393665
Study to Evaluate Efficacy, Safety and Tolerability of PENNEL Capsule in the Patients With Chronic Liver Disease
RandomizedParallel-groupQuadruple-blindTreatment
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
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 |