Hand, foot, and mouth disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 1 to 14 years who have been clinically diagnosed as mild HFMD, according to the Diagnosis and treatment guidelines of HFMD, 2010 version issued by Ministry of Health of China; (>1000 cases of mild HFMD in last year) The clinical diagnosis of uncomplicated HFMD was guided by fever with skin papular/vesicular rash on the hand, foot, mouth, or buttock. A few cases may not have fever; 2. In the absence of the World Health Organization standardized case definitions and guidelines for clinical management of HFMD cases, several countries developed their official guidelines. The guidelines issued by China emphasized the importance of diagnosis that is supported by clinical symptoms and laboratory diagnosis and of nervous system involvement; 3. Patients with a history of vesicles or fever with a maximum duration of 48 hours; 4. If patients with fever, the temperature no more than 39 degree; 5. Patients provide the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with congenital heart disease, chronic hepatitis, nephritis or hematological diseases; 2. Patients prone to allergies or with known allergy to the study drug; 3. Patients guardians with psychiatric disorders; 4. Patients with chronic diarrhea; 5. Patients already participate in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: Time to the first disappearance of oral ulcers and vesicles on hand or foot within 10 days (including 3-day follow up), and time to the first normalization of temperature (fever clearance);Developing rate of severe HFMD from participated patients; | — |
Countries
China
Contacts
Second affiliated hospital of Shantou university medical college