Hand, Foot and Mouth Disease
Conditions
Keywords
Chinese medicines, Severe hand-foot-mouth diseases, effectiveness, safety
Brief summary
The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe hand-foot-mouth disease.
Interventions
DRUGHerbal concentrate-granules plus western therapy
Intervention time: 7-10 days; Follow-up time: 5 days.
Intervention time: 7-10 days; Follow-up time: 5 days.
DRUGWestern therapy
Intervention time: 7-10 days; Follow-up time: 5 days.
Sponsors
State Administration of Traditional Chinese Medicine of the People's Republic of China
China Academy of Chinese Medical Sciences
Beijing University of Chinese Medicine
Beijing YouAn Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. not more than 24 hours of occurrence of severe symptoms 3. age of 1-13 years 4. Patients or their guardians agree to participate in this study and signed the informed consent form
Exclusion criteria
1. Suffering from neurogenic pulmonary edema, heart or lung failure. 2. Complicated with other serious diseases such as chronic hepatitis, congenital heart disease, acute or chronic nephritis and blood diseases, etc 3. the history of allergies on Chinese medicine 4. the history of mild increase of blood bilirubin hemolysis (or uric bravery former positive) phenomenon 5. using hormonal therapy 6. Attending other clinical studies on hand-foot-mouth disease 7. Patients or their guardians suffering from mental illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of complications | 15 days |
| incidence of critically ill patients | 15 days |
Secondary
| Measure | Time frame |
|---|---|
| time of bringing down a fever | 15 days |
| length of stay | 15 days |
| case fatality rate | 15 days |
| safety outcome(adverse effects) | 15 days |
| dose and usage of hormones | 15 days |
| time of symptom disappearance | 15 days |
Countries
China
Outcome results
None listed