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

NCT01393665 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2011-07-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PENNEL capsule

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

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • PharmaKing

    lead INDUSTRY

Principal Investigators

  • Minho Lee, MD.PhD · Hanyang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-12-31
Primary Completion
1997-05-31
Completion
1997-10-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01393665 on ClinicalTrials.gov