Clinical trial NCT01175915: A Clinical Trial To Evaluate Reduning Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hand, Foot and Mouth Disease
Keywords: Mild type of hand, foot and mouth disease
Reduning Injection
Effectiveness
Safety
Lead sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing University of Chinese Medicine
First posted: 2010-08-05
Enrollment: 360
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: time of bringing down the fever
timeFrame: 10 days
measure: time of body temperature going back to normal
timeFrame: 10 days
Secondary outcomes:
measure: time of symptom disappearance
timeFrame: 10 days
measure: time of tetter disappearance
timeFrame: 10 days
measure: dose and usage of medicine
timeFrame: 10 days
measure: case severity rate
timeFrame: 10 days
measure: adverse reaction incidence
timeFrame: 10 days
Other outcomes:
Locations:
city: Hefei
country: China
facility: An'Hui Provincial Children's Hospital
state: Anhui
city: Quanzhou
country: China
facility: Fujian Provincial Quanzhou City Children's Hospital
state: Fujian
city: Shijiazhuang
country: China
facility: The Fifth Hospital of Shijiazhuang City
state: Hebei
city: Kaifeng
country: China
facility: Kaifeng Municipal Children's Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Provincial Children's Hospital
state: Hunan
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
Study officials:
affiliation: Jiangsu Kanion Pharmaceutical Co., Ltd
name: Wei Xiao
role: PRINCIPAL_INVESTIGATOR
References: