A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Severe Type of Hand, Foot, and Mouth Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 3
- 主要终点
- complication rate
研究概览
简要总结
The study is aimed to evaluate the effectiveness and safety of Xiyanping injection,a traditional Chinese medicine (TCM), in the treatment of severe type of hand, foot, and mouth disease (HFMD).
详细描述
By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the effectiveness, safety and economic evaluation of a traditional Chinese medicine, Xiyanping injection,for treatment of HFMD, and to provide scientific evidence for the construction of TCM methods in treating HFMD.
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; More than 1/3 patients should be diagnosed by etiological examination.
- •Less than 24 hours of occurrence of fever and/or occurrence of tetter or herpes.
- •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
- •Complicated with other diseases such as neurogenic pulmonary edema, cardiopulmonary failure.
- •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 who using glucocorticoids for based diseases.
- •Patients who having history of hemolysis.
- •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 (mannitol, methylprednisolone, immunoglobulin, febrifuge) (Drug)
Xiyanping injection plus western therapy
干预措施: Xiyanping injection plus western therapy (Drug)
结局指标
主要结局
complication rate
时间窗: 15 days
Refering to the ratio of patient having complications such as pulmonary edema, myocarditis，damage of central nervous system，shock, respiratory failure, multiple organ failur etc.
次要结局
- time of body temperature going back to normal(15 days)
- time of symptom disappearance(15 days)
- safety outcome(15 days)