Study to Evaluate Efficacy and Safety of PENNEL Capsule in the Patients With Chronic Liver Disease

Study Overview
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Brief Summary
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The drug in this study is combined product of biphenyl dimethyl dicarboxylate (DDB) and garlic oil. This components showed synergistic enhancing effects in previous tests. In phase 2 test, 6 cap three times a day dosage (2cap T.I.D) is better than other dosage. Based on above, this study is phase 3 test to prove efficacy and safety of PENNEL.

Official Title
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A Multicenter, Randomized, Double-blind, 2 Parallel Group, Phase 3 Study of PENNEL Capsule in Chronic Liver Disease

Conditions
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Chronic Liver Disease

Intervention / Treatment
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* Drug: NISSEL
* Drug: PENNEL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with chronic hepatitis by biopsy Patients over 20, under 65 years of age. Patients with abnormal transaminase value. Exclusion Criteria: Pregnant and lactating women. Patients who have any history of esophageal bleeding, hepatic encephalopathy, ascites. Diabetes, thyroid dysfunction, fatty liver, liver cancer patients. Toxic hepatitis, alcoholic hepatitis. Total bilirubin value more than 3.0 mg/dl. Albumin value less than 3.0 g/dl. Patients who participating in other study about drug.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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>2cap T.I.D | Drug: PENNEL<br>* Biphenyl Dimethyl Dicarboxylate 25mg & garlic oil 50mg ............. 1cap<br>|
| Active Comparator: NISSEL<br>NISSEL BDD (biphenylmethyl dicarboxylate) ................25mg 2cap T.I.D | Drug: NISSEL<br>* Biphenyl Dimethyl Dicarboxylate 25mg ............. 1 cap<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALT(Alanine Aminotransferase) | To evaluate the efficacy of the PENNEL capsule on change ALT from baseline to 10 weeks (Change from Baseline in Alanine Aminotransferase at 10 weeks) The measurements were conducted four times, including ① before administration, ② the 4th week of administration, ③ the 8th week of administration ④ the 10th week of administration | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AST (Aspartate Aminotransferase) | To evaluate the efficacy of the PENNEL capsule on change AST from baseline to 10 weeks(Change from Baseline in Aspartate Aminotransferase at 10 weeks) The measurements were conducted four times, including ① before administration, ② the 4th week of administration, ③ the 8th week of administration ④ the 10th week of administration | 10 weeks | 
| g-GT (γ-glutamyl transpeptidase) | To evaluate the efficacy of the PENNEL capsule on change g-GT from baseline to 10 weeks (Change from Baseline in γ-glutamyl transpeptidase at 10 weeks) The measurements were conducted four times, including ① before administration, ② the 4th week of administration, ③ the 8th week of administration ④ the 10th week of administration | 10 weeks | 
| Total bilirubin | To evaluate the efficacy of the PENNEL capsule on change Total bilirubin from baseline to 10 weeks (Change from Baseline in Total bilirubin at 10 weeks) The measurements were conducted four times, including ① before administration, ② the 4th week of administration, ③ the 8th week of administration ④ the 10th week of administration | 10 weeks | 
| PLT (Platelet) | To evaluate the efficacy of the PENNEL capsule on change PLT from baseline to 10 weeks (Change from Baseline in Platelet count at 10 weeks) The measurements were conducted four times, including ① before administration, ② the 4th week of administration, ③ the 8th week of administration ④ the 10th week of administration | 10 weeks | 
| Total cholesterol | To evaluate the efficacy of the Oltipraz on change Total cholesterol from baseline to 10 weeks (Change from Baseline in Total cholesterol at 10 weeks) The measurements were conducted four times, including ① before administration, ② the 4th week of administration, ③ the 8th week of administration ④ the 10th week of administration | 10 weeks |