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

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Status: Completed

Conditions: Hand, Foot and Mouth Disease

Treatments: Other: Western therapy plus TCM treatment; Drug: TCM Syndrome Differentiation and Treatment; Other: Western therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01182532

200907001-3

Details and patient eligibility

About

The study is aimed to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) for treatment 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 traditional Chinese medicine for treatment of HFMD, and to provide scientific evidence for the construction of TCM methods in treating HFMD.

Enrollment: 3,000 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,000 participants in 3 patient groups

Western therapy

Active Comparator group

Treatment:

Other: Western therapy

TCM treatment

Experimental group

Treatment:

Drug: TCM Syndrome Differentiation and Treatment

Western therapy plus TCM treatment

Experimental group

Description:

The combination of both western therapy and TCM treatment.

Treatment:

Other: Western therapy plus TCM treatment