A randomized, double-blind, dose exploration, multicenter phase II clinical trial: Evaluation of the efficacy and safety of Xiao'er Qingzhen Oral liquid in treatment of stage 1 of young child hand-foot-and-mouth disease (syndrome of toxin accumulating Qi and Ying)
- Conditions
- hand-foot-and-mouth disease
- Registration Number
- ITMCTR1900002855
- Lead Sponsor
- The First Teaching Hospital of Tianjin University of TCM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to Resolution of Fever;
- Secondary Outcome Measures
Name Time Method 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;