Clinical trial NCT01182025: A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping 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
Xiyanping Injection
Effectiveness
Safety
Lead sponsor: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Beijing University of Chinese Medicine
name: China Academy of Chinese Medical Sciences
First posted: 2010-08-16
Enrollment: 360
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
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 Xiyanping Injection for mild type of hand, foot, and mouth disease.

Detailed description: By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the efficacy and safety of Xiyanping Injection in the treatment of mild type of Hand, Foot and Mouth Disease (HFMD), and designed to combine both observational and interventional methodologies in this research.

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 fever and/or occurrence of tetter or herpes.
* Age of 1-14 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 traditional Chinese medicine.
* Patients or their guardians suffering from Psychiatric diseases.
* 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: case severity rate
timeFrame: 10 days
measure: time of tetter disappearance
timeFrame: 10 days
measure: direct medical cost
timeFrame: 10 days
measure: safety outcome
timeFrame: 10 days
Other outcomes:
Locations:
city: Guilin
country: China
facility: Affiliated Hospital of Guilin Medical College
state: Guangxi
city: Liuzhou
country: China
facility: Liuzhou Worker's Hospital
state: Guangxi
city: Liuzhou
country: China
facility: Liuzhou People's Hospital
state: Guangxi
city: Shenzhen
country: China
facility: Shenzhen Maternity & Child Healthcare Hospital
state: Guangzhou
city: Nanchang
country: China
facility: Jiangxi Provincial Children's Hospital
state: Jiangxi
Study officials:
affiliation: An'Hui Chinese Medical College Affiliated No.1 Hospital
name: Guoliang Zhang
role: PRINCIPAL_INVESTIGATOR
References: