A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease

Capital Medical University

Status: Unknown

Conditions: Hand, Foot and Mouth Disease

Treatments: Drug: Western therapy; Drug: Reduning Injection plus western therapy; Drug: Herbal concentrate-granules plus western therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01145664

200907001-3

Details and patient eligibility

About

The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe hand-foot-mouth disease.

Enrollment: 390 estimated patients

Sex: All

Ages: 1 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
2. not more than 24 hours of occurrence of severe symptoms
3. age of 1-13 years
4. Patients or their guardians agree to participate in this study and signed the informed consent form

Exclusion criteria

1. Suffering from neurogenic pulmonary edema, heart or lung failure.
2. Complicated with other serious diseases such as chronic hepatitis, congenital heart disease, acute or chronic nephritis and blood diseases, etc
3. the history of allergies on Chinese medicine
4. the history of mild increase of blood bilirubin hemolysis (or uric bravery former positive) phenomenon
5. using hormonal therapy
6. Attending other clinical studies on hand-foot-mouth disease
7. Patients or their guardians suffering from mental illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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390 participants in 3 patient groups

Western therapy

Active Comparator group

Treatment:

Drug: Western therapy

Herbal concentrate-granules plus western therapy

Experimental group

Treatment:

Drug: Herbal concentrate-granules plus western therapy

Reduning Injection plus western therapy

Experimental group

Treatment:

Drug: Reduning Injection plus western therapy