Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 29 of 1425 for:    bilirubin AND alanine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01393678
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : July 13, 2011
Sponsor:
Information provided by:
PharmaKing

Tracking Information
First Submitted Date  ICMJE July 3, 2011
First Posted Date  ICMJE July 13, 2011
Last Update Posted Date July 13, 2011
Study Start Date  ICMJE November 1997
Actual Primary Completion Date March 1998   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2011)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Efficacy and Safety of PENNEL Capsule in the Patients With Chronic Liver Disease
Official Title  ICMJE A Multicenter, Randomized, Double-blind, 2 Parallel Group, Phase 3 Study of PENNEL Capsule in Chronic Liver Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Liver Disease
Intervention  ICMJE
  • Drug: NISSEL
    Biphenyl Dimethyl Dicarboxylate 25mg ............. 1 cap
  • Drug: PENNEL
    Biphenyl Dimethyl Dicarboxylate 25mg & garlic oil 50mg ............. 1cap
Study Arms  ICMJE
  • Experimental: PENNEL
    2cap T.I.D
    Intervention: Drug: PENNEL
  • Active Comparator: NISSEL

    NISSEL

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

    2cap T.I.D

    Intervention: Drug: NISSEL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2011)
220
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 1998
Actual Primary Completion Date March 1998   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01393678
Other Study ID Numbers  ICMJE PMK-PENNEL 3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party R&D department, CR team
Study Sponsor  ICMJE PharmaKing
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Minho Lee, MD.PhD Hanyang University
PRS Account PharmaKing
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP