A Clinical Trial To Evaluate Reduning Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
- Conditions
- Hand, Foot and Mouth Disease
- Interventions
- Other: Western therapyOther: Reduning InjectionOther: Reduning Injection plus western therapy
- Registration Number
- NCT01175915
- Lead Sponsor
- Jiangsu Kanion Pharmaceutical Co., Ltd
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 360
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Western therapy Western therapy - Reduning Injection Reduning Injection - Reduning Injection plus western therapy Reduning Injection plus western therapy -
- Primary Outcome Measures
Name Time Method time of bringing down the fever 10 days Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.
time of body temperature going back to normal 10 days 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.
- Secondary Outcome Measures
Name Time Method time of symptom disappearance 10 days Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used.
time of tetter disappearance 10 days 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.
dose and usage of medicine 10 days Refering to the dose and frequency of using the medicine.
case severity rate 10 days Refering to the ratio of patient with mild type of HFMD to severe type.
adverse reaction incidence 10 days Calculated by adverse event.
Trial Locations
- Locations (6)
Kaifeng Municipal Children's Hospital
🇨🇳Kaifeng, Henan, China
Hunan Provincial Children's Hospital
🇨🇳Changsha, Hunan, China
An'Hui Provincial Children's Hospital
🇨🇳Hefei, Anhui, China
Fujian Provincial Quanzhou City Children's Hospital
🇨🇳Quanzhou, Fujian, China
The Fifth Hospital of Shijiazhuang City
🇨🇳Shijiazhuang, Hebei, China
Shanghai Public Health Clinical Center
🇨🇳Shanghai, Shanghai, China