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
ConditionsHand, Foot and Mouth Disease
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.
Investigators
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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