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

PharmaKing

Status and phase

Completed

Phase 2

Conditions

Chronic Liver Disease

Treatments

Drug: Placebo

Drug: PENNEL capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT01393665

PMK-PENNEL 2

Details and patient eligibility

About

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.

Enrollment

88 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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.