NCT04766177招募中3 期
Role of Bumetanide in Treatment of Autism Spectrum Disorder in Children
Sherief Abd-Elsalam1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of patients with improved CARS score
研究概览
简要总结
Role of bumetanide in Autism
详细描述
Role of Bumetanide in Treatment of Autism spectrum disorder in children
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with ASD diagnosed by CARS rating Scale⩾
- •Age of patients range between (3-12) years.
排除标准
- •Patients with ASD associated with neurological antecedents (including epilepsies and febrile seizures), hepatic, renal dysfunction or electrocardiogram abnormalities and syndromatic children(Rett).
研究组 & 干预措施
bumetanide group
Experimental
Bumetanide a dose of 0.5 mg twice per day
干预措施: Bumetanide (Drug)
Placebo
Placebo Comparator
Placebo twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients with improved CARS score
时间窗: 6 months
the patients with improved CARS score
次要结局
未报告次要终点
研究者
Sherief Abd-Elsalam
Ass. Prof. Tropical Medicine
Tanta University
研究点 (1)
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