hand-foot-and-mouth disease
Conditions
Interventions
High dose group:1 ~ 3 years old (< 4 years old), high dose Xiao'er Qingzhen oral liquid 10ml/time, Tid
4 ~ 6 years old (< 7 years old), high dose Xiao'er Qingzhen oral liquid 15ml/time, Tid.
Extremely-low dose group:1 ~ 3 years old (< 4 years old), extremely-low dose Xiao'er Qingzhen oral liquid 10ml/time, Tid
4 ~ 6 years old (< 7 years old), extremely-low dose Xiao'er Qingzhen oral liquid 15ml/time, Tid.
Low dose group:1 ~ 3 years old (< 4 years old), low dose Xiao'er Qingzhen oral liquid 10ml/time, Tid
4 ~ 6 years old (< 7 years old), low dose Xiao'er Qingzhen oral liquid 15ml/time, Tid.
Sponsors
The First Teaching Hospital of Tianjin University of TCM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children who meet the stage 1 diagnostic criteria for hand, foot and mouth disease of western medicine; 2. Children who accord with the syndrome differentiation standard of syndrome of toxin accumulating Qi and Ying; 3. The maximum axillary temperature is >= 38 degree C 24h before treatment; 4. Aged 1 ~ 6 years; 5. Course of the disease is <= 24 hours; 6. The legal guardian signs the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Children with severe risk factors for HFMD included persistent high fever, nervous system manifestations, respiratory abnormalities, circulatory dysfunction, increased white blood cell count (>= 15 x 10^9/L), elevated fasting glucose ( > 8.3mmol/L), and elevated blood lactic acid ( >= 2.0mmol/L); 2. Children with varicella/shingles, rubella, herpetic pharyngitis, atypical measles, cheeper urgent rash, and papular urticaria; 3. Children with a history of febrile convulsions or seizures; 4. Children with severe malnutrition, rickets and severe primary diseases of the heart, brain, lung, liver, kidney and hematopoietic system; 5. Known or suspected to be allergic to the drug ingredients; 6. The investigator considers it inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Resolution of Fever; | — |
Secondary
| Measure | Time frame |
|---|---|
| negative rate of Viral ;Curative effect of TCM syndromes;disappear rate TCM symptoms (fever, rash/oral herpes, red face, headache, thirst, crying restlessness, yellow urine);Time of rash/oral herpes begins to shad;Time to resolution of rash/oral herpes;The rate of severe case; | — |
Countries
China
Contacts
Public ContactXinmin Li
The First Teaching Hospital of Tianjin University of TCM
Outcome results
None listed