Chinese Medicinal Treatment on Mild Hand, Foot, and Mouth Disease: Multicenter, Prospective, Randomized Double-blind, Placebo-controlled Study

China Academy of Chinese Medical Sciences

Status: Completed

Conditions: Hand, Foot and Mouth Disease

Treatments: Drug: JET; Drug: Placebo(for JET); Drug: Western therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01769794

ChinaACMS-HFMD

Details and patient eligibility

About

The study is aimed to evaluate the effectiveness and safety of Jinlianqingre Effervescent Tablets, a traditional Chinese medicine (TCM), in the treatment of Uncomplicated hand, foot, and mouth disease (HFMD).

Full description

By adopting a multicenter, prospective, randomized double-blind, placebo-controlled, this study is aimed to evaluate the effectiveness, safety of a traditional Chinese medicine, Jinlianqingre Effervescent Tablets, for treatment Uncomplicated HFMD, and to provide scientific evidence for the construction of TCM methods in treating HFMD.

Enrollment: 288 patients

Sex: All

Ages: 1 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of mild hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health;
• Within 48 hours of onset of fever and rash symptom.
• Age of 1-13 years.
• Documented body temperature 37.4 °C-39.0°C
• Patients or their guardians agree to participate in this study and signed the informed consent form.

Exclusion criteria

• Complicated with other serious diseases such as chronic hepatitis,chronic diarrhea disease,chronic diarrhea, congenital heart disease, acute or chronic nephritis and blood diseases.
• With history of allergies on traditional Chinese medicine.
• Attending other clinical studies on HFMD after diagnosed.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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288 participants in 2 patient groups

Western therapy & Placebo

Active Comparator group

Description:

Western therapy(oral care, skin care and reducing temperature) Placebo for JET(Jinlianqingre Effervescent Tablets )

Treatment:

Drug: Placebo(for JET)

Drug: Western therapy

Western therapy & JET

Experimental group

Description:

Jinlianqingre Effervescent Tablets plus western therapy

Treatment:

Drug: Western therapy

Drug: JET