A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Severe Type of Hand, Foot, and Mouth Disease
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
Intervention: Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge) (Drug)
Xiyanping injection plus western therapy
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)