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

Phase 2

Completed

• Conditions: Chronic Liver Disease
• Interventions: Drug: Placebo; Drug: PENNEL capsule

• Registration Number: NCT01393665
• Lead Sponsor: PharmaKing

Brief Summary

The test agent in this study is a product of biphenylmethyl dicarboxylate (BDD) with garlic oil. The two components were confirmed to have complementary effects because of different operational mechanism in animal experiments, and were examined on humans in this study. Both BDD and garlic oil are expected to show better protection and treatment on hepatotoxicity caused by toxic substances, and the purpose of this study is to confirm efficacy of and safety on human body of the agent and to determine its optimal dose.

Detailed Description

Not available

Study Timeline

• Study Start: 1996-12
• Primary Completion: 1997-05
• Study Completion: 1997-10
• Status Verified: 2011-07
• Study First Submitted: 2011-07-03
• Study First Submitted QC: 2011-07-12
• Last Update Submitted: 2011-07-12
• Study First Posted: 2011-07-13
• Last Update Posted: 2011-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Patients with chronic liver disease.
• Patients over 20, under 65 years of age.
• Patients with abnormal transaminase levels.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
PENNEL capsule	PENNEL capsule	1cap or 2cap T.I.D

Primary Outcome Measures

Name	Time	Method
ALT (Alanine Aminotransferase)	6 week	To evaluate the efficacy of the PENNEL capsule on change ALT from baseline to 6 weeks (Change from Baseline in Alanine Aminotransferase at 6 weeks); The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.

Secondary Outcome Measures

Name	Time	Method
AST (Aspartate Aminotransferase)	6 weeks	To evaluate the efficacy of the PENNEL capsule on change AST from baseline to 6 weeks (Change from Baseline in Aspartate Aminotransferase at 6 weeks); The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.
g-GT (γ-glutamyl transpeptidase)	6 weeks	To evaluate the efficacy of the PENNEL capsule on change g-GT from baseline to 6 weeks (Change from Baseline in γ-glutamyl transpeptidase at 6 weeks); The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.
Total bilirubin	6 weeks	To evaluate the efficacy of the PENNEL capsule on change Total bilirubin from baseline to 6 weeks (Change from Baseline in Total bilirubin at 6 weeks); The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.

Trial Locations

Locations (2)

Korea Cancer Center Hospital; 🇰🇷 Seoul, Nowon-gu, Korea, Republic of

Hanyang University Hospital; 🇰🇷 Seoul, Seongdong-gu, Korea, Republic of