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

Not Applicable

Completed

• Conditions: Hand, Foot, and Mouth Disease
• Interventions: Drug: Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge); Drug: Xiyanping injection plus western therapy

• Registration Number: NCT01554930
• Lead Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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.

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2010-11
• Study Completion: 2011-12
• Status Verified: 2012-03
• Study First Submitted: 2012-03-11
• Study First Submitted QC: 2012-03-14
• Last Update Submitted: 2012-03-14
• Study First Posted: 2012-03-15
• Last Update Posted: 2012-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Western therapy	Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge)	-
Xiyanping injection plus western therapy	Xiyanping injection plus western therapy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Liuzhou People's Hospital; 🇨🇳 Liuzhou, Guangxi, China

Handan Maternal and Child Health Care Hospital; 🇨🇳 Handan, Hebei, China

Jiangxi Children's Hospital; 🇨🇳 Nanchang, Jiangxi, China