Effect of Xiaoer Jiebiao Oral Liquid on Hand-foot-mouth Disease

Study Overview
=================
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.

Official Title
-----------------
Effect and Safety of Xiao'er Jiebiao Oral Liquid in Combination With Standard Treatment on Hand-foot-mouth Disease in Pediatric Patients

Conditions
-----------------
Handfoot-mouth Disease

Intervention / Treatment
-----------------
* Drug: Ribavirin plus Xiao'er jiebiao oral liquid
* Drug: Ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ribavirin treatment plus testing drug<br> | Drug: Ribavirin plus Xiao'er jiebiao oral liquid<br>* 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）<br>|
| Active Comparator: Ribavirin treatment<br> | Drug: Ribavirin<br>* 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）<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | top body temperature at 3 time points after treatment diarrhea | from starting of treatment to the 24th hour, 48th hour, and the 72th hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse digestive tract symptoms | proportion of patients with digestive tract symptoms during treatment, such as vomit, abdomial pain or diarrhea | from start of treatment to discharge | 
| abnormal blood routine | defined as 1 if any abnormal blood routine occur, otherwise defined as 0 | 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 | from the start of treatment to discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mild and Moderate Severe Patients With hand_foot-mouth Disease