A Clinical Trial To Evaluate Reduning Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease

Jiangsu Kanion Pharmaceutical

Status

Unknown

Conditions

Hand, Foot and Mouth Disease

Treatments

Other: Western therapy

Other: Reduning Injection

Other: Reduning Injection plus western therapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01175915

200907001-3-1

Details and patient eligibility

About

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

Full 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.

Enrollment

360 estimated 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 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.