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

July 20, 2012 updated by: Guoliang Zhang, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
The study is aimed to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) for treatment of hand, foot, and mouth disease (HFMD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 traditional Chinese medicine for treatment of HFMD, and to provide scientific evidence for the construction of TCM methods in treating HFMD.

Study Type

Interventional

Enrollment (Actual)

3000

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

  • China
    • Anhui
      • Hefei, Anhui, China
        • Anhui Provincial Children's Hospital
      • Hefei, Anhui, China
        • The First Affiliated Hospital of Anhui College of Traditional Chinese Medicine
    • Beijing
      • Beijing, Beijing, China
        • Beijing Ditan Hospital
      • Beijing, Beijing, China
        • Beijing You-An Hospital
    • Chongqing
      • Chongqing, Chongqing, China
        • Chongqing Hospital of Traditional Chinese Medicine
    • Fujian
      • Fuzhou, Fujian, China
        • Fuzhou Infectious Disease Hospital
      • Xiamen, Fujian, China
        • Xiamen Hospital of Traditional Chinese Medicine
    • Gausu
      • Lanzhou, Gausu, China
        • First Hospital of Lanzhou University
    • Guangzhou
      • Shenzhen, Guangzhou, China
        • Shenzhen Third People's Hospital
    • Hebei
      • Shijiazhuang, Hebei, China
        • The Fifth Hospital of Shijiazhuang, Hebei
    • Hubei
      • Wuhan, Hubei, China
        • Wuhan Hospital for Infectious Diseases
    • Inner Mongolia
      • Huhehaote, Inner Mongolia, China
        • Huhehaote Second Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Ninth Hospital of Nanchang
    • Jilin
      • Changchun, Jilin, China
        • Changchun Infectious Diseases Hospital
    • Ningxia Hui Autonomous
      • Yinchuan, Ningxia Hui Autonomous, China
        • Ningxia Hui Autonomous Region Forth People's Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China
        • The Eighth Hospital of Xi'an City
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai Public Health Center
    • Sichuan
      • Chengdu, Sichuan, China
        • Chengdu Hospital for Infectious Diseases
    • Xinjiang
      • Urumuqi, Xinjiang, China
        • Xinjiang Hongxing Hospital
    • Yunnan
      • Kunming, Yunnan, China
        • First Affiliated Hospital to Kunming Medical College
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The Sixth People's Hospital of Hangzhou

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

4 months to 12 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
Other: 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: TCM treatment
Drug: TCM Syndrome Differentiation and Treatment

  1. Lung-Spleen Damp-Heat Syndrome Symptoms: Fever, maculopapule and herpes on hand, foot and buttock; herpes on oral mucous membrane; redness in throat, salivation, tiredness, faint red tongue or reddish tongue, greasy fur, speedy pulse, red and purple fingerprint.

    Formula: Forsythia suspensa (Thunb.) vahl.(Lian Qiao), Lonicera japonica Thunb (Jin Yin Hua), Scutellaria baicalensis Georgi (Huang Qin), etc.

    Dosage: Adjusting by age and weight of patients. Decoction.

  2. Dampness-Heat Retention Syndrome Symptoms: High fever, dirty color of tetter, tiredness, oral ulcer, reddish tongue or deep red tongue, little saliva, yellow and greasy fur, fine and rapid pulse, deep purple fingerprint.

Formula: Forsythia suspensa (Thunb.) vahl.(Lian Qiao), Gardenia jasminoides Ellis (rough Zhi Zi), Scutellaria baicalensis Georgi (Huang Qin), etc.

Dosage: Adjusting by age and weight of patients. Decoction.
Experimental: Western therapy plus TCM treatment
The combination of both western therapy and TCM treatment.
Other: Western therapy plus TCM treatment
  1. Symptomatic treatment using the same treatment methods in western therapy group;
  2. Syndrome differentiation and treatment adopting the same methods in TCM treatment group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to onset
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
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

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
time of tetter and oral ulcer disappearance
Time Frame: 10 days
Refering to the length of time when the tetter due to HFMD disappears, characterised by no new tetter and oral ulcer develops, scab(s) or dropping; and time of oral ulcer concrescence, 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

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Collaborators

China Academy of Chinese Medical Sciences
Beijing University of Chinese Medicine

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

May 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 16, 2010

First Submitted That Met QC Criteria

August 16, 2010

First Posted (Estimate)

August 17, 2010

Study Record Updates

Last Update Posted (Estimate)

July 23, 2012

Last Update Submitted That Met QC Criteria

July 20, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200907001-3

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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