Effect and Safety of Xiao'er Jiebiao Oral Liquid in Combination With Standard Treatment on Hand-foot-mouth Disease in Pediatric Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Top body temperature at the 24th hour, 48th hour and the 72th hour from treatment starting.
研究概览
简要总结
This is a single-blinded randomized trial aiming to evaluate the effectiveness of Xiaoer Jiebiao Oral liquid in combination with Ribavirin treatment on patients with hand-foot-mouth disease compared with the controlgroup that recieve only libavirin treatment.
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
- Single (Participant)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects should meet all of the following
- •diagnosed as hand-foot-mouth disease grade I or grade II;
- •body temperature at admission T>38℃，fever length<48 hours;
- •no need for hormonotherapy or immunoglobulin therapy.
- •signed written informed consent form
排除标准
- •subjects should be excluded if meet any of the following
- •with history of any heart, lung, kidney or liver diseases; under any hormonotherapy, immunoglobulin therapy or any other therapy.
研究组 & 干预措施
Ribavirin treatment plus testing drug
干预措施: Ribavirin plus Xiao'er jiebiao oral liquid (Drug)
Ribavirin treatment
干预措施: Ribavirin (Drug)
结局指标
主要结局
Top body temperature at the 24th hour, 48th hour and the 72th hour from treatment starting.
时间窗: from starting of treatment to the 24th hour, 48th hour, and the 72th hour
top body temperature at 3 time points after treatment diarrhea
Time (hours) taken from treatment start till body temperature dropping to normal
时间窗: time length( hours) from treatment starting to the time that body temperature drop to normal 37.0 degree for 12 hours
Time (hours) taken from disease onset till body temperature dropping to normal
时间窗: time length (hours) from the disease onset (the starting of fever) till the time that body temperature dropped to normal (37.0 degree) and lasting for at least 12 hours
次要结局
- adverse digestive tract symptoms(from start of treatment to discharge)
- abnormal Urine routine(from the start of treatment to discharge)
- abnormal blood routine(from the start of treatment to discharge test)
研究者
Hui Yu
Professor, Director
Children's Hospital of Fudan University