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

Phase 3

Completed

• Conditions: Chronic Liver Disease
• Interventions: Drug: PENNEL; Drug: NISSEL

• Registration Number: NCT01393678
• Lead Sponsor: PharmaKing

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-11
• Primary Completion: 1998-03
• Study Completion: 1998-05
• 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: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PENNEL	PENNEL	2cap T.I.D
NISSEL	NISSEL	NISSEL BDD (biphenylmethyl dicarboxylate) ................25mg 2cap T.I.D

Primary Outcome Measures

Name	Time	Method
ALT(Alanine Aminotransferase)	10 weeks	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

Secondary Outcome Measures

Name	Time	Method
AST (Aspartate Aminotransferase)	10 weeks	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
g-GT (γ-glutamyl transpeptidase)	10 weeks	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
Total bilirubin	10 weeks	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
PLT (Platelet)	10 weeks	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
Total cholesterol	10 weeks	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

Trial Locations

Locations (1)

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