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

This study has been completed.
Sponsor:
Collaborators:
Beijing University of Chinese Medicine
China Academy of Chinese Medical Sciences
Information provided by (Responsible Party):
Guoliang Zhang, The First Affiliated Hospital of Anhui College of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01182532
First received: August 16, 2010
Last updated: July 20, 2012
Last verified: July 2012
  Purpose

The study is aimed to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) for treatment of hand, foot, and mouth disease (HFMD).


Condition Intervention
Hand, Foot and Mouth Disease
Other: Western therapy
Drug: TCM Syndrome Differentiation and Treatment
Other: Western therapy plus TCM treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • time to onset [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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:
  • time of symptom disappearance [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used.

  • case severity rate [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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 and oral ulcer disappearance [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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.

  • direct medical cost [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc.

  • safety outcome [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    Calculated by adverse event.


Enrollment: 3000
Study Start Date: May 2010
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   1 Year to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182532

  Show 21 Study Locations
Sponsors and Collaborators
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Beijing University of Chinese Medicine
China Academy of Chinese Medical Sciences
Investigators
Principal Investigator: Guoliang Zhang An'Hui Chinese Medical College Affiliated No.1 Hospital
  More Information

No publications provided

Responsible Party: Guoliang Zhang, Chief, The First Affiliated Hospital of Anhui College of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01182532     History of Changes
Other Study ID Numbers: 200907001-3
Study First Received: August 16, 2010
Last Updated: July 20, 2012
Health Authority: China: Ethics Committee

Keywords provided by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine:
Mild type of hand, foot and mouth disease
Traditional Chinese Medicine
Effectiveness
Safety

Additional relevant MeSH terms:
Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Mouth Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Coxsackievirus Infections
Enterovirus Infections
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 23, 2014