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Clinical Trials/NCT01554930
NCT01554930CompletedNot Applicable

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

Jiangxi Qingfeng Pharmaceutical Co. Ltd.3 sites in 1 country230 target enrollmentStarted: May 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
230
Locations
3
Primary Endpoint
complication rate

Study Overview

Brief Summary

The study is aimed to evaluate the effectiveness and safety of Xiyanping injection,a traditional Chinese medicine (TCM), in the treatment of severe type of hand, foot, and mouth disease (HFMD).

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
1 Year to 13 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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 24 hours of occurrence of fever and/or occurrence of tetter or herpes.
  • Age of 1-13 years.
  • Patients or their guardians agree to participate in this study and signed the informed consent form.

Exclusion Criteria

  • Complicated with other diseases such as neurogenic pulmonary edema, cardiopulmonary failure.
  • 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 who using glucocorticoids for based diseases.
  • Patients who having history of hemolysis.
  • Patients or their guardians suffering from Psychiatric diseases.
  • Attending other clinical studies on HFMD after diagnosed.

Arms & Interventions

Western therapy

Active Comparator

Intervention: Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge) (Drug)

Xiyanping injection plus western therapy

Experimental

Intervention: Xiyanping injection plus western therapy (Drug)

Outcomes

Primary Outcomes

complication rate

Time Frame: 15 days

Refering to the ratio of patient having complications such as pulmonary edema, myocarditis,damage of central nervous system,shock, respiratory failure, multiple organ failur etc.

Secondary Outcomes

  • time of body temperature going back to normal(15 days)
  • time of symptom disappearance(15 days)
  • safety outcome(15 days)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (3)

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