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

Study Overview
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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.

Official Title
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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

Conditions
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Chronic Liver Disease

Intervention / Treatment
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* Drug: Pennel
* Drug: Legalon
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pennel<br>This group will treated with DDB 25mg/Garlic oil 50mg for 12 weeks. | Drug: Pennel<br>* Pennel 2 Tablet, Legalon Placebo 1 tablet, Tid<br>* Other names: DDB/Garlic oil;|
| Active Comparator: Legalon<br>This group will treated with Silymarin 140mg for 12 weeks. | Drug: Legalon<br>* Pennel Placebo 2 Tablet, Legalon 1 tablet, Tid<br>* Other names: Silymarin;|
| Placebo Comparator: Placebo<br>This group will treated with Placebo for 12 weeks. | Drug: Placebo<br>* Pennel Placebo 2 Tablet, Legalon Placebo 1 tablet, Tid<br>* Other names: Lactose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalized rate in serum ALT | The rate of alanine aminotransferase (ALT) normalization | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALT |  | 8, 12 weeks | 
| AST |  | 8, 12 weeks | 
| γ-GTP |  | 8, 12 weeks | 
| AST/ALT ratio |  | 8, 12 weeks | 
| ALP |  | 8, 12 weeks | 
| Albumin |  | 8, 12 weeks | 
| Total Bilirubin |  | 8, 12 weeks | 
| The assessment of health-related quality of life |  | 12 weeks |