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

PharmaKing88 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Liver Disease

Interventions

PENNEL capsuleDRUG

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

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (2)

Korea Cancer Center Hospital

Seoul, Nowon-gu, South Korea

Hanyang University Hospital

Seoul, Seongdong-gu, South Korea

Outcomes

Primary Outcomes

ALT (Alanine Aminotransferase)

To evaluate the efficacy of the PENNEL capsule on change ALT from baseline to 6 weeks (Change from Baseline in Alanine Aminotransferase at 6 weeks) The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.

Time frame: 6 week

Secondary Outcomes

AST (Aspartate Aminotransferase)

To evaluate the efficacy of the PENNEL capsule on change AST from baseline to 6 weeks (Change from Baseline in Aspartate Aminotransferase at 6 weeks) The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.

Time frame: 6 weeks

g-GT (γ-glutamyl transpeptidase)

To evaluate the efficacy of the PENNEL capsule on change g-GT from baseline to 6 weeks (Change from Baseline in γ-glutamyl transpeptidase at 6 weeks) The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.

Time frame: 6 weeks

Total bilirubin

To evaluate the efficacy of the PENNEL capsule on change Total bilirubin from baseline to 6 weeks (Change from Baseline in Total bilirubin at 6 weeks) The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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