NCT04035317撤回2 期
Effect of Aesculus Hippocastanum L. (Sapindaceae, "Horse Chestnut") on Fontan Circulation - a Randomized Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mesenteric artery resistance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The capsules will be identical in appearance and will be labelled only with patient's name.
入排标准
- 年龄范围
- 2 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Underwent Fontan surgery
排除标准
- •Severe adverse reaction
- •Personal or parental request
研究组 & 干预措施
Aesculus hippocastanum
Experimental
Patients will receive extract of Aesculus hippocastanum
干预措施: Aesculus Hippocastanum / Horse Chestnut (Drug)
Placebo
Placebo Comparator
Patients will receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mesenteric artery resistance
时间窗: After 4 months
Mesenteric artery resistance, measured by pulsed-wave Doppler, in 0.1 units
次要结局
未报告次要终点
研究者
Fabio Carmona
MD, PhD
Casa Espirita Terra de Ismael
研究点 (1)
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