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

Chronic Liver Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02347319
• Other study ID #: P2010-PN004
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2013
• Last updated: January 26, 2015
• Start date: April 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2015
• Source: PharmaKing
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Purpose

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Liver Disease
• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	The catholic university of korea, Bucheon ST. Mary's Hosipital	Bucheon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
PharmaKing

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normalized rate in serum ALT	The rate of alanine aminotransferase (ALT) normalization	12 weeks	No
Secondary	ALT		8, 12 weeks	No
Secondary	AST		8, 12 weeks	No
Secondary	?-GTP		8, 12 weeks	No
Secondary	AST/ALT ratio		8, 12 weeks	No
Secondary	ALP		8, 12 weeks	No
Secondary	Albumin		8, 12 weeks	No
Secondary	Total Bilirubin		8, 12 weeks	No
Secondary	The assessment of health-related quality of life		12 weeks	No