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

• Status: Completed
• Trial end date: 1998-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PharmaKing
• Treatments: 7,7'-dimethoxy-(4,4'-bi-1,3-benzodioxole)-5,5'-dicarboxylic acid dimethyl ester

Criteria

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.