Chinese Medicinal Treatment on Mild Hand, Foot, and Mouth Disease: Multicenter, Prospective, Randomized Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 4
- 主要终点
- The time of body temperature going back to normal
研究概览
简要总结
The study is aimed to evaluate the effectiveness and safety of Jinlianqingre Effervescent Tablets, a traditional Chinese medicine (TCM), in the treatment of Uncomplicated hand, foot, and mouth disease (HFMD).
详细描述
By adopting a multicenter, prospective, randomized double-blind, placebo-controlled, this study is aimed to evaluate the effectiveness, safety of a traditional Chinese medicine, Jinlianqingre Effervescent Tablets, for treatment Uncomplicated 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 mild hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health;
- •Within 48 hours of onset of fever and rash symptom.
- •Age of 1-13 years.
- •Documented body temperature 37.4 °C-39.0°C
- •Patients or their guardians agree to participate in this study and signed the informed consent form.
排除标准
- •Complicated with other serious diseases such as chronic hepatitis,chronic diarrhea disease,chronic diarrhea, congenital heart disease, acute or chronic nephritis and blood diseases.
- •With history of allergies on traditional Chinese medicine.
- •Attending other clinical studies on HFMD after diagnosed.
研究组 & 干预措施
Western therapy & Placebo
Western therapy(oral care, skin care and reducing temperature) Placebo for JET(Jinlianqingre Effervescent Tablets )
干预措施: Western therapy (Drug)
Western therapy & Placebo
Western therapy(oral care, skin care and reducing temperature) Placebo for JET(Jinlianqingre Effervescent Tablets )
干预措施: Placebo(for JET) (Drug)
Western therapy & JET
Jinlianqingre Effervescent Tablets plus western therapy
干预措施: Western therapy (Drug)
Western therapy & JET
Jinlianqingre Effervescent Tablets plus western therapy
干预措施: JET (Drug)
结局指标
主要结局
The time of body temperature going back to normal
时间窗: 10 days
Referring 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
- Healing time of skin or oral mucosa lesions symptom(10 days)
- Score of skin or oral mucosa lesions symptom during the study period time(10 days)
- the length of hospital stay(10 days)
- major complications rate(10 days)
研究者
Liyun He
chief
China Academy of Chinese Medical Sciences