Back to resultsStudy to Evaluate Efficacy, Safety and Tolerability of PENNEL Capsule in the Patients With Chronic Liver Disease
Primary Purpose
Chronic Liver Disease
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PENNEL capsule
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Liver Disease
Eligibility Criteria
Inclusion Criteria:
- Patients with chronic liver disease.
- Patients over 20, under 65 years of age.
- Patients with abnormal transaminase levels.
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
- Korea Cancer Center Hospital
- Hanyang University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
PENNEL capsule
Arm Description
1cap or 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 6 weeks (Change from Baseline in Alanine Aminotransferase at 6 weeks)
The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.
Secondary Outcome Measures
AST (Aspartate Aminotransferase)
To evaluate the efficacy of the PENNEL capsule on change AST from baseline to 6 weeks (Change from Baseline in Aspartate Aminotransferase at 6 weeks)
The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.
g-GT (γ-glutamyl transpeptidase)
To evaluate the efficacy of the PENNEL capsule on change g-GT from baseline to 6 weeks (Change from Baseline in γ-glutamyl transpeptidase at 6 weeks)
The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.
Total bilirubin
To evaluate the efficacy of the PENNEL capsule on change Total bilirubin from baseline to 6 weeks (Change from Baseline in Total bilirubin at 6 weeks)
The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01393665
Brief Title
Study to Evaluate Efficacy, Safety and Tolerability of PENNEL Capsule in the Patients With Chronic Liver Disease
Official Title
Multicenter, Randomized, Placebo-Controlled, Double-blind Phase 2 Study to Evaluate the Short-term Efficacy, Safety and Tolerance and to Find an Optimal Dosage of the PENNEL Capsule for the Patients With Chronic Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
December 1996 (undefined)
Primary Completion Date
May 1997 (Actual)
Study Completion Date
October 1997 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
PharmaKing
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The test agent in this study is a product of biphenylmethyl dicarboxylate (BDD) with garlic oil. The two components were confirmed to have complementary effects because of different operational mechanism in animal experiments, and were examined on humans in this study. Both BDD and garlic oil are expected to show better protection and treatment on hepatotoxicity caused by toxic substances, and the purpose of this study is to confirm efficacy of and safety on human body of the agent and to determine its optimal dose.
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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
PENNEL capsule
Arm Type
Experimental
Arm Description
1cap or 2cap T.I.D
Intervention Type
Drug
Intervention Name(s)
PENNEL capsule
Intervention Description
hard capsule DDB 25mg & GO 50mg in cap .......... 1 capsule
1 or 2 capsule, T.I.D
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
ALT (Alanine Aminotransferase)
Description
To evaluate the efficacy of the PENNEL capsule on change ALT from baseline to 6 weeks (Change from Baseline in Alanine Aminotransferase at 6 weeks)
The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.
Time Frame
6 week
Secondary Outcome Measure Information:
Title
AST (Aspartate Aminotransferase)
Description
To evaluate the efficacy of the PENNEL capsule on change AST from baseline to 6 weeks (Change from Baseline in Aspartate Aminotransferase at 6 weeks)
The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.
Time Frame
6 weeks
Title
g-GT (γ-glutamyl transpeptidase)
Description
To evaluate the efficacy of the PENNEL capsule on change g-GT from baseline to 6 weeks (Change from Baseline in γ-glutamyl transpeptidase at 6 weeks)
The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.
Time Frame
6 weeks
Title
Total bilirubin
Description
To evaluate the efficacy of the PENNEL capsule on change Total bilirubin from baseline to 6 weeks (Change from Baseline in Total bilirubin at 6 weeks)
The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.
Time Frame
6 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 with chronic liver disease.
Patients over 20, under 65 years of age.
Patients with abnormal transaminase levels.
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
Korea Cancer Center Hospital
City
Seoul
State/Province
Nowon-gu
ZIP/Postal Code
139706
Country
Korea, Republic of
Facility Name
Hanyang University Hospital
City
Seoul
State/Province
Seongdong-gu
ZIP/Postal Code
133792
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
22943930
Citation
Lee MH, Kim YM, Kim SG. Efficacy and tolerability of diphenyl-dimethyl-dicarboxylate plus garlic oil in patients with chronic hepatitis. Int J Clin Pharmacol Ther. 2012 Nov;50(11):778-86. doi: 10.5414/CP201746.
Results Reference
derived
Learn more about this trial
Study to Evaluate Efficacy, Safety and Tolerability of PENNEL Capsule in the Patients With Chronic Liver Disease
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