Observation on therapeutic effect of Qingjie Jie Re granule on children influenza
Phase 4
- Conditions
- influenza
- Registration Number
- ITMCTR2200005693
- Lead Sponsor
- Children's Hospital of Fudan University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1. Meet the western diagnostic criteria for influenza; 2. Out-patient children with the course of disease within 48 hours; 3. Conforming to the syndrome differentiation standard of TCM wind-heat syndrome; 4. Aged from 3 to 12; 5. The informed consent process is in accordance with the provisions, and the legal representative or the subject child (=8 years old) jointly signed the informed consent.
Exclusion Criteria
1. Severe or critical cases of influenza; 2. Antiviral drugs were used within 48 hours before this visit; 3. Children with chronic and serious underlying diseases; 4. Children with intolerance to study drugs; 5. The researcher thinks that the person is not suitable to participate in this experiment.
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events/reactions occurred during treatment were recorded;CARIFS symptom dimension score and its area under the curve relative to time;Disappearance rate of single symptom;Hospitalization rates;Use rate of antifebrile drugs;Vital signs (temperature, respiration, heart rate, blood pressure), blood routine, urine routine, ELECTROcardiogram, liver function (ALT, AST, ALP), kidney function (BUN, Cr);Curative effect of TCM syndromes (cure rate);Influenza virus nucleic acid negative conversion rate;Time of antipyretic effect;Time for complete fever reduction;Duration of immediate fever reduction;
- Secondary Outcome Measures
Name Time Method