A Clinical Trial To Evaluate Reduning 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 Reduning Injection for mild type of hand-foot-mouth disease.

Detailed Description
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By adopting a multi-center, prospective, randomized and controlled clinical trial, this study is aimed to evaluate the efficacy and safety of Reduning Injection in the treatment of mild type of Hand, Foot and Mouth Disease (HFMD), and to provide medical evidence of Reduning Injection for HFMD, especially to offer suggestions in clinical practice.

Conditions
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Hand, Foot and Mouth Disease

Intervention / Treatment
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* Other: Western therapy
* Other: Reduning Injection
* Other: Reduning 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 48 hours of occurrence of mild symptoms, with an armpit temperature of more than 37.5 degrees Celsius. Less than 48 hours of 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 serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc. With history of allergies on the experimental medicine, or severe allergies to other medicines. Using other western medicine or Chinese medicine for treating HFMD when consulted. 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Western therapy<br> | Other: Western therapy<br>* 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 lasting for more than 2 hours; No specific treatment for tetter and ulcer, but Bingpeng powder, Watermelon tablet or frost for oral herpes. Intervention time: 3-7 days; Follow-up time: 3 days.<br>|
| Experimental: Reduning Injection<br> | Other: Reduning Injection<br>* Lifestyle counseling, vitamin supplementation if necessary, and non-use of antibiotics; Reduning Injection, 0.5 15ml, depending on patient's condition, IV per day, or according to the instruction; Using Ibuprofen suspension when patient's temperature higher than 39 degree Celsius lasting for more than 2 hours. Intervention time: 3-7 days; Follow-up time: 3 days.<br>|
| Experimental: Reduning Injection plus western therapy<br> | Other: Reduning Injection plus western therapy<br>* General treatment including lifestyle counseling, vitamin supplementation if necessary, non-use of antibiotics, and symptomatic treatment as follows; Symptomatic treatment by western therapy adopting the same plan in western therapy comparator group; Symptomatic treatment by Reduning Injection adopting the same plan in Reduning Injection experimental group. Intervention time: 3-7 days; Follow-up time: 3 days.<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 | 
| 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 | 
| dose and usage of medicine | Refering to the dose and frequency of using the medicine. | 10 days | 
| case severity rate | Refering to the ratio of patient with mild type of HFMD to severe type. | 10 days | 
| adverse reaction incidence | 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, Reduning Injection, Effectiveness, Safety