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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 1998

Interventions

  • Drug: NISSEL
    • Biphenyl Dimethyl Dicarboxylate 25mg …………. 1 cap
  • Drug: PENNEL
    • Biphenyl Dimethyl Dicarboxylate 25mg & garlic oil 50mg …………. 1cap

Arms, Groups and Cohorts

  • Experimental: PENNEL
    • 2cap T.I.D
  • Active Comparator: NISSEL
    • NISSEL BDD (biphenylmethyl dicarboxylate) …………….25mg 2cap T.I.D

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • PharmaKing
  • Provider of Information About this Clinical Study
    • R&D department, CR team
  • Overall Official(s)
    • Minho Lee, MD.PhD, Principal Investigator, Hanyang University

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