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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2013

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.

Interventions

  • Drug: Pennel
    • Pennel 2 Tablet, Legalon Placebo 1 tablet, Tid
  • Drug: Legalon
    • Pennel Placebo 2 Tablet, Legalon 1 tablet, Tid
  • Drug: Placebo
    • Pennel Placebo 2 Tablet, Legalon Placebo 1 tablet, Tid

Arms, Groups and Cohorts

  • Experimental: Pennel
    • This group will treated with DDB 25mg/Garlic oil 50mg for 12 weeks.
  • Active Comparator: Legalon
    • This group will treated with Silymarin 140mg for 12 weeks.
  • Placebo Comparator: Placebo
    • This group will treated with Placebo for 12 weeks.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • PharmaKing
  • Provider of Information About this Clinical Study
    • Sponsor

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