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

• Status: Completed
• Trial end date: 1997-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PharmaKing

Criteria

Inclusion Criteria:

• Patients with chronic liver disease.

• Patients over 20, under 65 years of age.

• Patients with abnormal transaminase levels.

Exclusion Criteria:

• Pregnant and lactating women.

• Patients who have any history of esophageal bleeding, hepatic encephalopathy, ascites.

• Diabetes, thyroid dysfunction, fatty liver, liver cancer patients.

• Toxic hepatitis, alcoholic hepatitis.

• Total bilirubin value more than 3.0 mg/dl.

• Albumin value less than 3.0 g/dl.

• Patients who participating in other study about drug.