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

Not Applicable

• Conditions: Hand, Foot and Mouth Disease
• Interventions: Other: Western therapy; Drug: Xiyanping Injection; Drug: Xiyanping Injection with western medicine

• Registration Number: NCT01182025
• Lead Sponsor: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Brief Summary

The aim of this study is to evaluate the effectiveness and safety of Xiyanping Injection for mild type of hand, foot, and mouth disease.

Detailed Description

By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the efficacy and safety of Xiyanping Injection in the treatment of mild type of Hand, Foot and Mouth Disease (HFMD), and designed to combine both observational and interventional methodologies in this research.

Study Timeline

• Study Start: 2010-06
• Status Verified: 2010-08
• Study First Submitted: 2010-08-13
• Study First Submitted QC: 2010-08-13
• Study First Posted: 2010-08-16
• Last Update Submitted: 2010-08-16
• Last Update Posted: 2010-08-17
• Primary Completion: 2011-05
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Western therapy	Western therapy	-
Xiyanping Injection	Xiyanping Injection	-
Xiyanping Injection with western medicine	Xiyanping Injection with western medicine	-

Primary Outcome Measures

Name	Time	Method
time of bringing down the fever	10 days	Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.
time of body temperature going back to normal	10 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.

Secondary Outcome Measures

Name	Time	Method
time of symptom disappearance	10 days	Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used.
case severity rate	10 days	Refering to the ratio of patient with mild type of HFMD to severe type, such as damage of central nervous system, pulmonary edema, heart failure, respiratory failure, etc.
time of tetter disappearance	10 days	Refering to the length of time when the tetter due to HFMD disappears, characterised by scab(s) or dropping; and time of oral ulcer concrescence, etc.
direct medical cost	10 days	Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc.
safety outcome	10 days	Calculated by adverse event.

Trial Locations

Locations (5)

Affiliated Hospital of Guilin Medical College; 🇨🇳 Guilin, Guangxi, China

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

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

Shenzhen Maternity & Child Healthcare Hospital; 🇨🇳 Shenzhen, Guangzhou, China

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