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

Primary Purpose

Chronic Liver Disease

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Pennel

Legalon

Placebo

About this trial

This is an interventional treatment trial for Chronic Liver Disease

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Pennel

Legalon

Placebo

Arm Description

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

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

This group will treated with Placebo for 12 weeks.

Outcomes

Primary Outcome Measures

Normalized rate in serum ALT

The rate of alanine aminotransferase (ALT) normalization

Secondary Outcome Measures

ALT

AST

γ-GTP

AST/ALT ratio

ALP

Albumin

Total Bilirubin

The assessment of health-related quality of life

Full Information

NCT ID

NCT02347319

First Posted

June 11, 2013

Last Updated

January 26, 2015

Sponsor

PharmaKing

1. Study Identification

Unique Protocol Identification Number

NCT02347319

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PharmaKing

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Liver Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

262 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pennel

Arm Type

Experimental

Arm Description

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

Arm Title

Legalon

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

This group will treated with Placebo for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Pennel

Other Intervention Name(s)

DDB/Garlic oil

Intervention Description

Pennel 2 Tablet, Legalon Placebo 1 tablet, Tid

Intervention Type

Drug

Intervention Name(s)

Legalon

Other Intervention Name(s)

Silymarin

Intervention Description

Pennel Placebo 2 Tablet, Legalon 1 tablet, Tid

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Lactose

Intervention Description

Pennel Placebo 2 Tablet, Legalon Placebo 1 tablet, Tid

Primary Outcome Measure Information:

Title

Normalized rate in serum ALT

Description

The rate of alanine aminotransferase (ALT) normalization

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

ALT

Time Frame

8, 12 weeks

Title

AST

Time Frame

8, 12 weeks

Title

γ-GTP

Time Frame

8, 12 weeks

Title

AST/ALT ratio

Time Frame

8, 12 weeks

Title

ALP

Time Frame

8, 12 weeks

Title

Albumin

Time Frame

8, 12 weeks

Title

Total Bilirubin

Time Frame

8, 12 weeks

Title

The assessment of health-related quality of life

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

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

City

Bucheon

State/Province

Gyeonggi-do

ZIP/Postal Code

420-717

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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