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Clinical Trials/NCT01145664
NCT01145664
Unknown
Not Applicable

A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease

Beijing YouAn Hospital6 sites in 1 country390 target enrollmentMay 2010

Overview

Phase
Not Applicable
Intervention
Western therapy
Conditions
Hand, Foot and Mouth Disease
Sponsor
Beijing YouAn Hospital
Enrollment
390
Locations
6
Primary Endpoint
incidence of complications
Last Updated
15 years ago

Overview

Brief Summary

The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe hand-foot-mouth disease.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
August 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Beijing YouAn Hospital

Eligibility 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
  • not more than 24 hours of occurrence of severe symptoms
  • age of 1-13 years
  • Patients or their guardians agree to participate in this study and signed the informed consent form

Exclusion Criteria

  • Suffering from neurogenic pulmonary edema, heart or lung failure.
  • Complicated with other serious diseases such as chronic hepatitis, congenital heart disease, acute or chronic nephritis and blood diseases, etc
  • the history of allergies on Chinese medicine
  • the history of mild increase of blood bilirubin hemolysis (or uric bravery former positive) phenomenon
  • using hormonal therapy
  • Attending other clinical studies on hand-foot-mouth disease
  • Patients or their guardians suffering from mental illness

Arms & Interventions

Western therapy

Intervention: Western therapy

Herbal concentrate-granules plus western therapy

Intervention: Herbal concentrate-granules plus western therapy

Reduning Injection plus western therapy

Intervention: Reduning Injection plus western therapy

Outcomes

Primary Outcomes

incidence of complications

Time Frame: 15 days

incidence of critically ill patients

Time Frame: 15 days

Secondary Outcomes

  • dose and usage of hormones(15 days)
  • safety outcome(adverse effects)(15 days)
  • case fatality rate(15 days)
  • time of symptom disappearance(15 days)
  • time of bringing down a fever(15 days)
  • length of stay(15 days)

Study Sites (6)

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