Effectiveness and Safety of Chinese Medicine to Treat Hand, Foot, and Mouth Disease

Qingfeng Pharmaceutical

Status

Completed

Conditions

Hand, Foot, and Mouth Disease

Treatments

Drug: Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge)

Drug: Xiyanping injection plus western therapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01554930

200907001-3

Details and patient eligibility

About

The study is aimed to evaluate the effectiveness and safety of Xiyanping injection,a traditional Chinese medicine (TCM), in the treatment of severe type of hand, foot, and mouth disease (HFMD).

Full description

By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the effectiveness, safety and economic evaluation of a traditional Chinese medicine, Xiyanping injection,for treatment of HFMD, and to provide scientific evidence for the construction of TCM methods in treating HFMD.

Enrollment

230 patients

Sex

All

Ages

1 to 13 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 24 hours of occurrence of fever and/or 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 diseases such as neurogenic pulmonary edema, cardiopulmonary failure.
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 who using glucocorticoids for based diseases.
Patients who having history of hemolysis.
Patients or their guardians suffering from Psychiatric diseases.
Attending other clinical studies on HFMD after diagnosed.