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

NCT ID: NCT01182025

Last Updated: 2010-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Hand, Foot and Mouth Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Western therapy

Group Type ACTIVE_COMPARATOR

Western therapy

Intervention Type OTHER

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 Injection

Group Type EXPERIMENTAL

Xiyanping Injection

Intervention Type DRUG

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 medicine

Group Type EXPERIMENTAL

Xiyanping Injection with western medicine

Intervention Type DRUG

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

Interventions

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Western therapy

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;

Intervention Type OTHER

Xiyanping Injection

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.

Intervention Type DRUG

Xiyanping Injection with western medicine

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing University of Chinese Medicine

OTHER

Sponsor Role collaborator

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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The First Affiliated Hospital of Anhui College of Traditional Chinese Medicine

Principal Investigators

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Guoliang Zhang

Role: PRINCIPAL_INVESTIGATOR

An'Hui Chinese Medical College Affiliated No.1 Hospital

Locations

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Affiliated Hospital of Guilin Medical College

Guilin, Guangxi, China

Site Status RECRUITING

Liuzhou Worker's Hospital

Liuzhou, Guangxi, China

Site Status RECRUITING

Liuzhou People's Hospital

Liuzhou, Guangxi, China

Site Status RECRUITING

Shenzhen Maternity & Child Healthcare Hospital

Shenzhen, Guangzhou, China

Site Status RECRUITING

Jiangxi Provincial Children's Hospital

Nanchang, Jiangxi, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Xiong Li

Role: primary

13737728526

Liuping Tang

Role: primary

18977228768

Zhe Guo

Role: backup

13978009767

Tong Yang

Role: primary

13977286628

Xinying Zou

Role: primary

13129559135

Qingxiong Zhu

Role: primary

15979003000

Other Identifiers

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200907001-4

Identifier Type: -

Identifier Source: org_study_id

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