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

PharmaKing220 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

220

Conditions

Chronic Liver Disease

Interventions

NISSELDRUG

Biphenyl Dimethyl Dicarboxylate 25mg ............. 1 cap

PENNELDRUG

Biphenyl Dimethyl Dicarboxylate 25mg \& garlic oil 50mg ............. 1cap

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hanyang University Hospital

Seoul, Seongdong-gu,, South Korea

Outcomes

Primary Outcomes

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

Time frame: 10 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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