Back to resultsStudy to Evaluate Efficacy and Safety of PENNEL Capsule in the Patients With Chronic Liver Disease
Primary Purpose
Chronic Liver Disease
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
NISSEL
PENNEL
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Liver Disease
Eligibility Criteria
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.
Sites / Locations
- Hanyang University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PENNEL
NISSEL
Arm Description
2cap T.I.D
NISSEL BDD (biphenylmethyl dicarboxylate) ................25mg 2cap T.I.D
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
AST (Aspartate Aminotransferase)
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)
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
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)
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01393678
Brief Title
Study to Evaluate Efficacy and Safety of PENNEL Capsule in the Patients With Chronic Liver Disease
Official Title
A Multicenter, Randomized, Double-blind, 2 Parallel Group, Phase 3 Study of PENNEL Capsule in Chronic Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
November 1997 (undefined)
Primary Completion Date
March 1998 (Actual)
Study Completion Date
May 1998 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
PharmaKing
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PENNEL
Arm Type
Experimental
Arm Description
2cap T.I.D
Arm Title
NISSEL
Arm Type
Active Comparator
Arm Description
NISSEL
BDD (biphenylmethyl dicarboxylate) ................25mg
2cap T.I.D
Intervention Type
Drug
Intervention Name(s)
NISSEL
Intervention Description
Biphenyl Dimethyl Dicarboxylate 25mg ............. 1 cap
Intervention Type
Drug
Intervention Name(s)
PENNEL
Intervention Description
Biphenyl Dimethyl Dicarboxylate 25mg & garlic oil 50mg ............. 1cap
Primary Outcome Measure Information:
Title
ALT(Alanine Aminotransferase)
Description
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
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
AST (Aspartate Aminotransferase)
Description
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
Time Frame
10 weeks
Title
g-GT (γ-glutamyl transpeptidase)
Description
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
Time Frame
10 weeks
Title
Total bilirubin
Description
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
Time Frame
10 weeks
Title
PLT (Platelet)
Description
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
Time Frame
10 weeks
Title
Total cholesterol
Description
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
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minho Lee, MD.PhD
Organizational Affiliation
Hanyang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanyang University Hospital
City
Seoul, Seongdong-gu,
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate Efficacy and Safety of PENNEL Capsule in the Patients With Chronic Liver Disease
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