Skip to main content
OpenTrials
Completed

NCT Number: NCT02347319

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

Purpose

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Liver Disease

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Bucheon-si, Gyeonggi-do, 420-717, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pennel

Drug

Pennel 2 Tablet, Legalon Placebo 1 tablet, Tid

Other names: DDB/Garlic oil

Legalon

Drug

Pennel Placebo 2 Tablet, Legalon 1 tablet, Tid

Other names: Silymarin

Placebo

Drug

Pennel Placebo 2 Tablet, Legalon Placebo 1 tablet, Tid

Other names: Lactose

Primary outcomes

  1. Normalized rate in serum ALT

    Time frame: 12 weeks

    The rate of alanine aminotransferase (ALT) normalization

Secondary outcomes

  1. ALT

    Time frame: 8, 12 weeks

  2. AST

    Time frame: 8, 12 weeks

  3. γ-GTP

    Time frame: 8, 12 weeks

  4. AST/ALT ratio

    Time frame: 8, 12 weeks

  5. ALP

    Time frame: 8, 12 weeks

  6. Albumin

    Time frame: 8, 12 weeks

  7. Total Bilirubin

    Time frame: 8, 12 weeks

  8. The assessment of health-related quality of life

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

PharmaKing

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 27, 2015
Registry last updated
Jan 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.