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

January 26, 2015 updated by: PharmaKing

A Double-Blind, Randomized, Multicenter Trial Examining the Efficacy of Biphenyl Dimethyl Dicarboxylate Combined With Garlic Oil in Patients With Transaminase Elevated Chronic Liver Disease

Purpose

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

Study Overview

Status

Completed

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 Type

Interventional

Enrollment (Actual)

262

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gyeonggi-do
      • Bucheon, Gyeonggi-do, Korea, Republic of, 420-717
        • The catholic university of korea, Bucheon ST. Mary's Hosipital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pennel
This group will treated with DDB 25mg/Garlic oil 50mg for 12 weeks.
Pennel 2 Tablet, Legalon Placebo 1 tablet, Tid
Other Names:
  • DDB/Garlic oil
Active Comparator: Legalon
This group will treated with Silymarin 140mg for 12 weeks.
Pennel Placebo 2 Tablet, Legalon 1 tablet, Tid
Other Names:
  • Silymarin
Placebo Comparator: Placebo
This group will treated with Placebo for 12 weeks.
Pennel Placebo 2 Tablet, Legalon Placebo 1 tablet, Tid
Other Names:
  • Lactose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normalized rate in serum ALT
Time Frame: 12 weeks
The rate of alanine aminotransferase (ALT) normalization
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
ALT
Time Frame: 8, 12 weeks
8, 12 weeks
AST
Time Frame: 8, 12 weeks
8, 12 weeks
γ-GTP
Time Frame: 8, 12 weeks
8, 12 weeks
AST/ALT ratio
Time Frame: 8, 12 weeks
8, 12 weeks
ALP
Time Frame: 8, 12 weeks
8, 12 weeks
Albumin
Time Frame: 8, 12 weeks
8, 12 weeks
Total Bilirubin
Time Frame: 8, 12 weeks
8, 12 weeks
The assessment of health-related quality of life
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 11, 2013

First Submitted That Met QC Criteria

January 26, 2015

First Posted (Estimate)

January 27, 2015

Study Record Updates

Last Update Posted (Estimate)

January 27, 2015

Last Update Submitted That Met QC Criteria

January 26, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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