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

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

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Guangxi
      • Guilin, Guangxi, China, 541001
        • Recruiting
        • Affiliated Hospital of Guilin Medical College
        • Contact:
        • Principal Investigator:
          • Xiong Li
      • Liuzhou, Guangxi, China, 541001
        • Recruiting
        • Liuzhou worker's hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Liuping Tang
        • Principal Investigator:
          • Zhe Guo
      • Liuzhou, Guangxi, China, 545001
        • Recruiting
        • Liuzhou People's Hospital
        • Contact:
        • Principal Investigator:
          • Tong Yang
    • Guangzhou
      • Shenzhen, Guangzhou, China, 518028
        • Recruiting
        • Shenzhen Maternity & Child Healthcare Hospital
        • Contact:
        • Principal Investigator:
          • Xinying Zou
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • Jiangxi Provincial Children's Hospital
        • Contact:
        • Principal Investigator:
          • Qingxiong Zhu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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;
Experimental: 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.

Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time of body temperature going back to normal
Time Frame: 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.
10 days
time of bringing down the fever
Time Frame: 10 days
Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time of symptom disappearance
Time Frame: 10 days
Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used.
10 days
case severity rate
Time Frame: 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.
10 days
direct medical cost
Time Frame: 10 days
Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc.
10 days
safety outcome
Time Frame: 10 days
Calculated by adverse event.
10 days
time of tetter disappearance
Time Frame: 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.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Guoliang Zhang, An'Hui Chinese Medical College Affiliated No.1 Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

May 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

August 13, 2010

First Submitted That Met QC Criteria

August 13, 2010

First Posted (Estimate)

August 16, 2010

Study Record Updates

Last Update Posted (Estimate)

August 17, 2010

Last Update Submitted That Met QC Criteria

August 16, 2010

Last Verified

August 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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