A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-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 Chinese herbal medicines for severe hand-foot-mouth disease.

Conditions
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Hand, Foot and Mouth Disease

Intervention / Treatment
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* Drug: Herbal concentrate-granules plus western therapy
* Drug: Reduning Injection plus western therapy
* Drug: 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 not more than 24 hours of occurrence of severe symptoms age of 1-13 years Patients or their guardians agree to participate in this study and signed the informed consent form Exclusion Criteria: Suffering from neurogenic pulmonary edema, heart or lung failure. Complicated with other serious diseases such as chronic hepatitis, congenital heart disease, acute or chronic nephritis and blood diseases, etc the history of allergies on Chinese medicine the history of mild increase of blood bilirubin hemolysis (or uric bravery former positive) phenomenon using hormonal therapy Attending other clinical studies on hand-foot-mouth disease Patients or their guardians suffering from mental illness

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<br>* Intervention time: 7-10 days; Follow-up time: 5 days.<br>|
| Experimental: Herbal concentrate-granules plus western therapy<br> | Drug: Herbal concentrate-granules plus western therapy<br>* Intervention time: 7-10 days; Follow-up time: 5 days.<br>|
| Experimental: Reduning Injection plus western therapy<br> | Drug: Reduning Injection plus western therapy<br>* Intervention time: 7-10 days; Follow-up time: 5 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of complications |  | 15 days | 
| incidence of critically ill patients |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| case fatality rate |  | 15 days | 
| time of symptom disappearance |  | 15 days | 
| time of bringing down a fever |  | 15 days | 
| length of stay |  | 15 days | 
| dose and usage of hormones |  | 15 days | 
| safety outcome(adverse effects) |  | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chinese medicines, Severe hand-foot-mouth diseases, effectiveness, safety