NCT01393678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 1997

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1997

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 1998

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 1998

Completed
13.2 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 13, 2011

Completed
Last Updated

July 13, 2011

Status Verified

July 1, 2011

Enrollment Period

4 months

First QC Date

July 3, 2011

Last Update Submit

July 12, 2011

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

  • ALT(Alanine Aminotransferase)

    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

    10 weeks

Secondary Outcomes (5)

  • AST (Aspartate Aminotransferase)

    10 weeks

  • g-GT (γ-glutamyl transpeptidase)

    10 weeks

  • Total bilirubin

    10 weeks

  • PLT (Platelet)

    10 weeks

  • Total cholesterol

    10 weeks

Study Arms (2)

PENNEL

EXPERIMENTAL

2cap T.I.D

Drug: PENNEL

NISSEL

ACTIVE COMPARATOR

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

Drug: NISSEL

Interventions

NISSELDRUG

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

NISSEL
PENNELDRUG

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

PENNEL

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with chronic hepatitis by biopsy
  • Patients over 20, under 65 years of age.
  • Patients with abnormal transaminase value.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang University Hospital

Seoul, Seongdong-gu,, South Korea

Location

Study Officials

  • Minho Lee, MD.PhD

    Hanyang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 3, 2011

First Posted

July 13, 2011

Study Start

November 1, 1997

Primary Completion

March 1, 1998

Study Completion

May 1, 1998

Last Updated

July 13, 2011

Record last verified: 2011-07

Locations

KR(1)