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

N/AUnknownNCT01182025

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine360 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

360

Conditions

Hand, Foot and Mouth Disease

Interventions

Western therapyOTHER

Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care. 1. Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius; 2. Using Ibuprofen suspension when patient's temperature higher than 38.5 degree Celsius;

Xiyanping InjectionDRUG

Dosage for child medication: 5-10mg/kg/d (0.2-0.4ml/kg/d) in 5% Glucose solution, IV, with speed of 20-30 drops per minute, each day; or as directed by doctor.

Xiyanping Injection with western medicineDRUG

1. Symptomatic treatment using the same treatment methods in western therapy group; 2. Symptomatic treatment using the same treatment methods in Xiyanpin injection group.

Eligibility

Sex: ALLMin age: 1 YearMax age: 14 Years

Medical Language ↔ Plain English

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.

Locations (5)

Affiliated Hospital of Guilin Medical College

Guilin, Guangxi, China

RECRUITING

Liuzhou Worker's Hospital

Liuzhou, Guangxi, China

RECRUITING

Liuzhou People's Hospital

Liuzhou, Guangxi, China

Outcomes

Primary Outcomes

time of bringing down the fever

Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.

Time frame: 10 days

time of body temperature going back to normal

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 frame: 10 days

Secondary Outcomes

time of symptom disappearance

Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used.

Time frame: 10 days

case severity rate

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 frame: 10 days

time of tetter disappearance

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.

Time frame: 10 days

direct medical cost

Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc.

Time frame: 10 days

safety outcome

Calculated by adverse event.

Time frame: 10 days

Data from ClinicalTrials.gov

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