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

NCT ID: NCT02347319

Last Updated: 2015-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-06-30

Brief Summary

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Purpose

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

Detailed Description

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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.

Conditions

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Chronic Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pennel

This group will treated with DDB 25mg/Garlic oil 50mg for 12 weeks.

Group Type EXPERIMENTAL

Pennel

Intervention Type DRUG

Pennel 2 Tablet, Legalon Placebo 1 tablet, Tid

Legalon

This group will treated with Silymarin 140mg for 12 weeks.

Group Type ACTIVE_COMPARATOR

Legalon

Intervention Type DRUG

Pennel Placebo 2 Tablet, Legalon 1 tablet, Tid

Placebo

This group will treated with Placebo for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Pennel Placebo 2 Tablet, Legalon Placebo 1 tablet, Tid

Interventions

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Pennel

Pennel 2 Tablet, Legalon Placebo 1 tablet, Tid

Intervention Type DRUG

Legalon

Pennel Placebo 2 Tablet, Legalon 1 tablet, Tid

Intervention Type DRUG

Placebo

Pennel Placebo 2 Tablet, Legalon Placebo 1 tablet, Tid

Intervention Type DRUG

Other Intervention Names

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DDB/Garlic oil Silymarin Lactose

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PharmaKing

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Bucheon-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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P2010-PN004

Identifier Type: -

Identifier Source: org_study_id

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