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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01554930

Enrollment

230

Registered

2012-03-15

Start date

2010-05-31

Completion date

2011-12-31

Last updated

2012-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand, Foot, and Mouth Disease

Keywords

HFMD, Traditional Chinese Medicine, Xiyanping

Brief summary

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).

Detailed 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.

Interventions

DRUGWestern therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge)

Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.

DRUGXiyanping injection plus western therapy

Xiyanping injection:5-10mg/kg/d (0.2-0.4ml/kg/d),qd ivgtt; Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 13 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
complication rate	15 days	Refering to the ratio of patient having complications such as pulmonary edema, myocarditis，damage of central nervous system，shock, respiratory failure, multiple organ failur etc.

Secondary

Measure	Time frame	Description
time of body temperature going back to normal	15 days	Refering to the time of the armpit temperature of lower than 37.0 degrees Celsius, lasting for at least 24 hours, after the medicine is taken.
time of symptom disappearance	15 days	Referring to the length of time when clinical symptoms and signs totally disappear after the medicine is used.
safety outcome	15 days	Calculated by adverse event

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026