To Evaluate the Efficacy of DDB/Garlic Oil in Patients With Elevated Transaminase Chronic Liver Disease

PharmaKing262 enrolled

Overview

Purpose \- To evaluate the efficacy of Biphenyl dimethyl dicarboxylate(DDB)/Garlic Oil in patients with elevated transaminase chronic liver disease.

Biphenyl dimethyl dicarboxylate (DDB) combined with garlic oil (pennel) has been used to treat chronic liver disease. A randomized, double-blind, active- and placebo-controlled clinical trial was conducted to investigate the efficacy, safety and quality of life in chronic liver disease patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

262

Conditions

Chronic Liver Disease

Interventions

PennelDRUG

Pennel 2 Tablet, Legalon Placebo 1 tablet, Tid

LegalonDRUG

Pennel Placebo 2 Tablet, Legalon 1 tablet, Tid

PlaceboDRUG

Pennel Placebo 2 Tablet, Legalon Placebo 1 tablet, Tid

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients over 20years of age * Patients with more 60 ALT in screening period. * To evaluate ALT and AST at least three months. * Serum Transaminase abnormal(before 6months), chronic liver disease or fatty liver, liver disease medical treatment at more than 30days * Women of childbearing age get her consent for contraception, pregnancy urine test result negative. Exclusion Criteria: * ALT\>10UNL on screening period. * Current treatment on another clinical trial * Pregnancy or breastfeeding

Locations (1)

The catholic university of korea, Bucheon ST. Mary's Hosipital

Bucheon-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Normalized rate in serum ALT

The rate of alanine aminotransferase (ALT) normalization

Time frame: 12 weeks

Secondary Outcomes

ALT

Time frame: 8, 12 weeks

AST

Time frame: 8, 12 weeks

γ-GTP

Time frame: 8, 12 weeks

AST/ALT ratio

Time frame: 8, 12 weeks

ALP

Time frame: 8, 12 weeks

Albumin

Time frame: 8, 12 weeks

Total Bilirubin

Time frame: 8, 12 weeks

The assessment of health-related quality of life

Time frame: 12 weeks

Data from ClinicalTrials.gov

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