A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Status

Unknown

Conditions

Hand, Foot and Mouth Disease

Treatments

Drug: Xiyanping Injection

Other: Western therapy

Drug: Xiyanping Injection with western medicine

Study type

Interventional

Funder types

Other

Identifiers

NCT01182025

200907001-4

Details and patient eligibility

About

The aim of this study is to evaluate the effectiveness and safety of Xiyanping Injection for mild type of hand, foot, and mouth disease.

Full 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.

Enrollment

360 estimated patients

Sex

All

Ages

1 to 14 years old

Volunteers

No Healthy Volunteers

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.