A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 360
- 试验地点
- 5
- 主要终点
- time of bringing down the fever
研究概览
简要总结
The aim of this study is to evaluate the effectiveness and safety of Xiyanping Injection for mild type of hand, foot, and mouth disease.
详细描述
By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the efficacy and safety of Xiyanping Injection in the treatment of mild type of Hand, Foot and Mouth Disease (HFMD), and designed to combine both observational and interventional methodologies in this research.
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 14 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; More than 1/3 patients should be diagnosed by etiological examination.
- •Less than 48 hours of occurrence of fever and/or occurrence of tetter or herpes.
- •Age of 1-14 years.
- •Patients or their guardians agree to participate in this study and signed the informed consent form.
排除标准
- •Complicated with other serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc.
- •With history of allergies on traditional Chinese medicine.
- •Patients or their guardians suffering from Psychiatric diseases.
- •Attending other clinical studies on HFMD after diagnosed.
研究组 & 干预措施
Western therapy
干预措施: Western therapy (Other)
Xiyanping Injection
干预措施: Xiyanping Injection (Drug)
Xiyanping Injection with western medicine
干预措施: Xiyanping Injection with western medicine (Drug)
结局指标
主要结局
time of bringing down the fever
时间窗: 10 days
Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.
time of body temperature going back to normal
时间窗: 10 days
Refering to the time of the armpit temperature of lower than 37.0 degrees Celsius, lasting for at least 24 hours, after the medicine is taken.
次要结局
- time of symptom disappearance(10 days)
- case severity rate(10 days)
- time of tetter disappearance(10 days)
- direct medical cost(10 days)
- safety outcome(10 days)