A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,000
- 试验地点
- 21
- 主要终点
- time to onset
研究概览
简要总结
The study is aimed to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) for treatment 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 traditional Chinese medicine 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 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)
TCM treatment
干预措施: TCM Syndrome Differentiation and Treatment (Drug)
Western therapy plus TCM treatment
The combination of both western therapy and TCM treatment.
干预措施: Western therapy plus TCM treatment (Other)
结局指标
主要结局
time to onset
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 and oral ulcer disappearance(10 days)
- direct medical cost(10 days)
- safety outcome(10 days)
研究者
Guoliang Zhang
Chief
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine