- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02347319
To Evaluate the Efficacy of DDB/Garlic Oil in Patients With Elevated Transaminase Chronic Liver Disease
January 26, 2015 updated by: PharmaKing
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
Purpose
- To evaluate the efficacy of Biphenyl dimethyl dicarboxylate(DDB)/Garlic Oil in patients with elevated transaminase chronic liver disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
262
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
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Bucheon, Gyeonggi-do, Korea, Republic of, 420-717
- The catholic university of korea, Bucheon ST. Mary's Hosipital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pennel
This group will treated with DDB 25mg/Garlic oil 50mg for 12 weeks.
|
Pennel 2 Tablet, Legalon Placebo 1 tablet, Tid
Other Names:
|
Active Comparator: Legalon
This group will treated with Silymarin 140mg for 12 weeks.
|
Pennel Placebo 2 Tablet, Legalon 1 tablet, Tid
Other Names:
|
Placebo Comparator: Placebo
This group will treated with Placebo for 12 weeks.
|
Pennel Placebo 2 Tablet, Legalon Placebo 1 tablet, Tid
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Normalized rate in serum ALT
Time Frame: 12 weeks
|
The rate of alanine aminotransferase (ALT) normalization
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ALT
Time Frame: 8, 12 weeks
|
8, 12 weeks
|
AST
Time Frame: 8, 12 weeks
|
8, 12 weeks
|
γ-GTP
Time Frame: 8, 12 weeks
|
8, 12 weeks
|
AST/ALT ratio
Time Frame: 8, 12 weeks
|
8, 12 weeks
|
ALP
Time Frame: 8, 12 weeks
|
8, 12 weeks
|
Albumin
Time Frame: 8, 12 weeks
|
8, 12 weeks
|
Total Bilirubin
Time Frame: 8, 12 weeks
|
8, 12 weeks
|
The assessment of health-related quality of life
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
June 11, 2013
First Submitted That Met QC Criteria
January 26, 2015
First Posted (Estimate)
January 27, 2015
Study Record Updates
Last Update Posted (Estimate)
January 27, 2015
Last Update Submitted That Met QC Criteria
January 26, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P2010-PN004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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