NCT07388615招募中2 期
The Effect of Echinacea (Immulant ®) in the Treatment of CRYPTOSPORIDIOSIS in Immunocompromised Children
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To measure the changes in parasite count in stool samples after treatment
研究概览
简要总结
This study aims to:
- To evaluate the effectiveness of Immulant ® addition to standard treatment in reducing clinical symptoms of Cryptosporidiosis in immunocompromised children.
- To measure the changes in parasite count in stool samples after treatment with Immulant ®.
- To assess the safety and tolerability of Immulant ® in children participating in the study.
详细描述
The present prospective study will be (open labelled) Randomized Clinical Trial and was approved by the Research Ethical Committee Of national nutritional institute. Oral and written consent will be obtained from all patients and controls after a full explanation of the study.
A total of at least 60 immunocompromised children consecutively diagnosed with cryptosporidiosis were recruited from the outpatient clinic of National Nutritional Institute.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Cryptosporidiosis Disease
- •Age from 5-12 years
- •Immunocompromised children
- •Not receiving any drugs causing immunosuppression
排除标准
- •Patients undergoing organ transplantation
- •Patients suffering from autoimmune diseases.
- •Patients suffering from hypersensitivity of this plant extract
研究组 & 干预措施
interventional arm
Active Comparator
干预措施: Echinacea Extract (Drug)
结局指标
主要结局
To measure the changes in parasite count in stool samples after treatment
时间窗: six months
次要结局
未报告次要终点
研究者
Maha Abd Elrhman
Principal Investigator
Al-Azhar University
研究点 (1)
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