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

Phase 4

Completed

• Conditions: Chronic Liver Disease
• Interventions: Drug: Pennel; Drug: Placebo; Drug: Legalon

• Registration Number: NCT02347319
• Lead Sponsor: PharmaKing

Brief Summary

Purpose

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

Detailed Description

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 Timeline

• Study Start: 2012-04
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Study First Submitted: 2013-06-11
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-26
• Last Update Submitted: 2015-01-26
• Study First Posted: 2015-01-27
• Last Update Posted: 2015-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pennel	Pennel	This group will treated with DDB 25mg/Garlic oil 50mg for 12 weeks.
Placebo	Placebo	This group will treated with Placebo for 12 weeks.
Legalon	Legalon	This group will treated with Silymarin 140mg for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Normalized rate in serum ALT	12 weeks	The rate of alanine aminotransferase (ALT) normalization

Secondary Outcome Measures

Name	Time	Method
Total Bilirubin	8, 12 weeks
AST/ALT ratio	8, 12 weeks
γ-GTP	8, 12 weeks
ALP	8, 12 weeks
Albumin	8, 12 weeks
ALT	8, 12 weeks
AST	8, 12 weeks
The assessment of health-related quality of life	12 weeks

Trial Locations

Locations (1)

The catholic university of korea, Bucheon ST. Mary's Hosipital; 🇰🇷 Bucheon, Gyeonggi-do, Korea, Republic of