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

PharmaKing

Status and phase: Completed; Phase 3

Conditions: Chronic Liver Disease

Treatments: Drug: NISSEL; Drug: PENNEL

Study type: Interventional

Funder types: Industry

Identifiers

NCT01393678

PMK-PENNEL 3

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 2 patient groups

PENNEL

Experimental group

Description:

2cap T.I.D

Treatment:

Drug: PENNEL

NISSEL

Active Comparator group

Description:

NISSEL BDD (biphenylmethyl dicarboxylate) ................25mg 2cap T.I.D

Treatment:

Drug: NISSEL