Handfoot-mouth Disease
Conditions
Keywords
Mild and Moderate Severe Patients With hand_foot-mouth Disease
Brief summary
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.
Interventions
DRUGRibavirin plus Xiao'er jiebiao oral liquid
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）
DRUGRibavirin
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）
Sponsors
Weihai Rensheng Pharmacy
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time (hours) taken from treatment start till body temperature dropping to normal | 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 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. | from starting of treatment to the 24th hour, 48th hour, and the 72th hour | top body temperature at 3 time points after treatment diarrhea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse digestive tract symptoms | from start of treatment to discharge | proportion of patients with digestive tract symptoms during treatment, such as vomit, abdomial pain or diarrhea |
| abnormal blood routine | from the start of treatment to discharge test | defined as 1 if any abnormal blood routine occur, otherwise defined as 0 |
| abnormal Urine routine | from the start of treatment to discharge | defined as 1 if any liver function examination or kidney function examination occur, otherwise defined as 0 |
Countries
China
Outcome results
None listed