A Clinical Trial To Evaluate Reduning Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hand, Foot and Mouth Disease
- Sponsor
- Jiangsu Kanion Pharmaceutical Co., Ltd
- Enrollment
- 360
- Locations
- 6
- Primary Endpoint
- time of bringing down the fever
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
time of bringing down the fever
Time Frame: 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
Time Frame: 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 Outcomes
- time of symptom disappearance(10 days)
- time of tetter disappearance(10 days)
- dose and usage of medicine(10 days)
- case severity rate(10 days)
- adverse reaction incidence(10 days)