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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| PENNEL capsule | Experimental | 1cap or 2cap T.I.D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PENNEL capsule | Drug | hard capsule DDB 25mg & GO 50mg in cap .......... 1 capsule 1 or 2 capsule, T.I.D |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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 |
|---|---|---|---|---|---|---|
| Korea Cancer Center Hospital | Seoul | Nowon-gu | 139706 | South Korea | ||
| Hanyang University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22943930 | Derived | 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. |
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| Placebo | Drug | Placebo |
|
| 6 weeks |
| 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. | 6 weeks |
| 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. | 6 weeks |
| Seoul |
| Seongdong-gu |
| 133792 |
| South Korea |