Trial | NCT01393665  Report issue

Title

Study to Evaluate Efficacy, Safety and Tolerability of PENNEL Capsule in the Patients With Chronic Liver Disease
Multicenter, Randomized, Placebo-Controlled, Double-blind Phase 2 Study to Evaluate the Short-term Efficacy, Safety and Tolerance and to Find an Optimal Dosage of the PENNEL Capsule for the Patients With Chronic Liver Disease

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    88
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.
Study Started
Dec 31
1996
Primary Completion
May 31
1997
Study Completion
Oct 31
1997
Last Update
Jul 13
2011
Estimate

Drug PENNEL capsule

hard capsule DDB 25mg & GO 50mg in cap .......... 1 capsule 1 or 2 capsule, T.I.D

Drug Placebo

Placebo

Placebo Placebo Comparator

PENNEL capsule Experimental

1cap or 2cap T.I.D

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.
No Results Posted