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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
For mild (Phase I) patients: recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, ivgg, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years. For moderate (Phase II) patients: recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.③anti-intracranial pressure treatment: mannitol 2\~5ml/kg,iv, Bid\~tid）
For mild (PhaseI) patients : recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip. For moderate (PhaseII) patients: recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.③anti-intracranial pressure treatment: mannitol 2\~5ml/kg, iv, Bid\~tid）
Children's Hospital of Fudan University
Shanghai, China
Time (hours) taken from treatment start till body temperature dropping to normal
Time frame: 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
Time frame: 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
Top body temperature at the 24th hour, 48th hour and the 72th hour from treatment starting.
top body temperature at 3 time points after treatment diarrhea
Time frame: from starting of treatment to the 24th hour, 48th hour, and the 72th hour
adverse digestive tract symptoms
proportion of patients with digestive tract symptoms during treatment, such as vomit, abdomial pain or diarrhea
Time frame: from start of treatment to discharge
abnormal blood routine
defined as 1 if any abnormal blood routine occur, otherwise defined as 0
Time frame: from the start of treatment to discharge test
abnormal Urine routine
defined as 1 if any liver function examination or kidney function examination occur, otherwise defined as 0
Time frame: from the start of treatment to discharge
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