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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
230
Mannitol:0.5-1.0g/kg,q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin:1g/kg; Others:febrifuge,sedative,etc.
Xiyanping injection:5-10mg/kg/d (0.2-0.4ml/kg/d),qd ivgtt; Mannitol:0.5-1.0g/kg,q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin:1g/kg; Others:febrifuge,sedative,etc.
Liuzhou People's Hospital
Liuchow, Guangxi, China
Handan Maternal and Child Health Care Hospital
Handan, Hebei, China
Jiangxi Children's Hospital
Nanchang, Jiangxi, China
complication rate
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.
Time frame: 15 days
time of body temperature going back to normal
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.
Time frame: 15 days
time of symptom disappearance
Referring to the length of time when clinical symptoms and signs totally disappear after the medicine is used.
Time frame: 15 days
safety outcome
Calculated by adverse event
Time frame: 15 days
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