A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effectiveness and safety of Xiyanping Injection for mild type of hand, foot, and mouth disease.

Detailed Description
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By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the efficacy and safety of Xiyanping Injection in the treatment of mild type of Hand, Foot and Mouth Disease (HFMD), and designed to combine both observational and interventional methodologies in this research.

Conditions
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Hand, Foot and Mouth Disease

Intervention / Treatment
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* Other: Western therapy
* Drug: Xiyanping Injection
* Drug: Xiyanping Injection with western medicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of severe hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health; More than 1/3 patients should be diagnosed by etiological examination. Less than 48 hours of occurrence of fever and/or occurrence of tetter or herpes. Age of 1-14 years. Patients or their guardians agree to participate in this study and signed the informed consent form. Exclusion Criteria: Complicated with other serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc. With history of allergies on traditional Chinese medicine. Patients or their guardians suffering from Psychiatric diseases. Attending other clinical studies on HFMD after diagnosed.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Western therapy<br> | Other: Western therapy<br>* Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care. Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius; Using Ibuprofen suspension when patient's temperature higher than 38.5 degree Celsius;<br>|
| Experimental: Xiyanping Injection<br> | Drug: Xiyanping Injection<br>* Dosage for child medication: 5-10mg/kg/d (0.2-0.4ml/kg/d) in 5% Glucose solution, IV, with speed of 20-30 drops per minute, each day; or as directed by doctor.<br>|
| Experimental: Xiyanping Injection with western medicine<br> | Drug: Xiyanping Injection with western medicine<br>* Symptomatic treatment using the same treatment methods in western therapy group; Symptomatic treatment using the same treatment methods in Xiyanpin injection group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of bringing down the fever | Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken. | 10 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. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of symptom disappearance | Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used. | 10 days | 
| case severity rate | Refering to the ratio of patient with mild type of HFMD to severe type, such as damage of central nervous system, pulmonary edema, heart failure, respiratory failure, etc. | 10 days | 
| time of tetter disappearance | Refering to the length of time when the tetter due to HFMD disappears, characterised by scab(s) or dropping; and time of oral ulcer concrescence, etc. | 10 days | 
| direct medical cost | Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc. | 10 days | 
| safety outcome | Calculated by adverse event. | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild type of hand, foot and mouth disease, Xiyanping Injection, Effectiveness, Safety