NCT01145664Unknown不适用
A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease
Beijing YouAn Hospital6 个研究点 分布在 1 个国家目标入组 390 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 390
- 试验地点
- 6
- 主要终点
- incidence of complications
研究概览
简要总结
The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe hand-foot-mouth disease.
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
- None
入排标准
- 年龄范围
- 1 Year 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of severe hand-foot-mouth disease patients according to hand-foot-mouth disease treatment guidelines 2010 issued by China's Ministry of Health
- •not more than 24 hours of occurrence of severe symptoms
- •age of 1-13 years
- •Patients or their guardians agree to participate in this study and signed the informed consent form
排除标准
- •Suffering from neurogenic pulmonary edema, heart or lung failure.
- •Complicated with other serious diseases such as chronic hepatitis, congenital heart disease, acute or chronic nephritis and blood diseases, etc
- •the history of allergies on Chinese medicine
- •the history of mild increase of blood bilirubin hemolysis (or uric bravery former positive) phenomenon
- •using hormonal therapy
- •Attending other clinical studies on hand-foot-mouth disease
- •Patients or their guardians suffering from mental illness
研究组 & 干预措施
Western therapy
Active Comparator
干预措施: Western therapy (Drug)
Herbal concentrate-granules plus western therapy
Experimental
干预措施: Herbal concentrate-granules plus western therapy (Drug)
Reduning Injection plus western therapy
Experimental
干预措施: Reduning Injection plus western therapy (Drug)
结局指标
主要结局
incidence of complications
时间窗: 15 days
incidence of critically ill patients
时间窗: 15 days
次要结局
- dose and usage of hormones(15 days)
- safety outcome(adverse effects)(15 days)
- case fatality rate(15 days)
- time of symptom disappearance(15 days)
- time of bringing down a fever(15 days)
- length of stay(15 days)
研究者
研究点 (6)
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