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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PENNEL | Experimental | 2cap T.I.D |
|
| NISSEL | Active Comparator | NISSEL BDD (biphenylmethyl dicarboxylate) ................25mg 2cap T.I.D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NISSEL | Drug | Biphenyl Dimethyl Dicarboxylate 25mg ............. 1 cap |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Minho Lee, MD.PhD | Hanyang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University Hospital | Seoul, Seongdong-gu, | South Korea |
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| PENNEL |
| Drug |
Biphenyl Dimethyl Dicarboxylate 25mg & garlic oil 50mg ............. 1cap |
|
| 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 | 10 weeks |
| 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 | 10 weeks |
| 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 | 10 weeks |
| 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 | 10 weeks |