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The graduate student quit.
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| Name | Class |
|---|---|
| Hospital das ClÃnicas de Ribeirão Preto | OTHER |
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Patients after the Fontan operation at a single institution will be randomized to receive a standardized extract of Aesculus hippocastanum L. (horse chestnut) or placebo for 4 months in a crossover clinical trial. The primary outcome will be the mesenteric artery resistance measured by Dopple sonography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aesculus hippocastanum | Experimental | Patients will receive extract of Aesculus hippocastanum |
|
| Placebo | Placebo Comparator | Patients will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aesculus Hippocastanum / Horse Chestnut | Drug | Treatment for 4 months, washout of 4 weeks, then crossover for another 4 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mesenteric artery resistance | Mesenteric artery resistance, measured by pulsed-wave Doppler, in 0.1 units | After 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das ClÃnicas da Faculdade de Medicina de Ribeirão Preto | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
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| ID | Term |
|---|---|
| D000080039 | Univentricular Heart |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| C517354 | horse chestnut seed |
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Patients will be randomized to receive Aesculus hippocastanum or placebo for 4 months, followed by 4 weeks of washout and crossover.
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The capsules will be identical in appearance and will be labelled only with patient's name.
| Placebo | Drug | Treatment for 4 months, washout of 4 weeks, then crossover for another 4 months. |
|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |