Effectiveness and Safety of Chinese Medicine to Treat Hand, Foot, and Mouth Disease

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Severe Type of Hand, Foot, and Mouth Disease

Conditions
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Hand, Foot, and Mouth Disease

Intervention / Treatment
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* Drug: Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge)
* Drug: Xiyanping injection plus western therapy


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 24 hours of occurrence of fever and/or occurrence of tetter or herpes. Age of 1-13 years. Patients or their guardians agree to participate in this study and signed the informed consent form. Exclusion Criteria: Complicated with other diseases such as neurogenic pulmonary edema, cardiopulmonary failure. 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 who using glucocorticoids for based diseases. Patients who having history of hemolysis. 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: 13 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> | Drug: Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge)<br>* Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.<br>|
| Experimental: Xiyanping injection plus western therapy<br> | Drug: Xiyanping injection plus western therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 15 days | 
| time of symptom disappearance | Referring to the length of time when clinical symptoms and signs totally disappear after the medicine is used. | 15 days | 
| safety outcome | Calculated by adverse event | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HFMD, Traditional Chinese Medicine, Xiyanping