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Completed

NCT Number: NCT01393678

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

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.

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Key information

Conditions

Chronic Liver Disease

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hanyang University Hospital

Seoul, Seongdong-gu,, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NISSEL

Drug

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

Pennel

Drug

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

Primary outcomes

  1. ALT(Alanine Aminotransferase)

    Time frame: 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 outcomes

  1. AST (Aspartate Aminotransferase)

    Time frame: 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

  2. g-GT (γ-glutamyl transpeptidase)

    Time frame: 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

  3. Total bilirubin

    Time frame: 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

  4. PLT (Platelet)

    Time frame: 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

  5. Total cholesterol

    Time frame: 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

Sponsors and collaborators

Lead sponsor

PharmaKing

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, 2 Parallel Group, Phase 3 Study of PENNEL Capsule in Chronic Liver Disease

Important dates

Study start
1997
Primary completion
1998
Study completion
1998
First posted
Jul 13, 2011
Registry last updated
Jul 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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