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

NCT ID: NCT01393678

Last Updated: 2011-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-11-30

Study Completion Date

1998-05-31

Brief Summary

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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

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Conditions

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Chronic Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PENNEL

2cap T.I.D

Group Type EXPERIMENTAL

PENNEL

Intervention Type DRUG

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

NISSEL

NISSEL

BDD (biphenylmethyl dicarboxylate) ................25mg

2cap T.I.D

Group Type ACTIVE_COMPARATOR

NISSEL

Intervention Type DRUG

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

Interventions

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NISSEL

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

Intervention Type DRUG

PENNEL

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PharmaKing

INDUSTRY

Sponsor Role lead

Responsible Party

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CR team

Principal Investigators

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Minho Lee, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Hanyang University

Locations

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Hanyang University Hospital

Seoul, Seongdong-gu,, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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PMK-PENNEL 3

Identifier Type: -

Identifier Source: org_study_id

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