A randomized, double-blind, parallel controlled, multicenter clinical trial for the efficacy and safety of Bairui granule in the treatment of acute upper respiratory tract infection (wind heat syndrome) in childre
- Conditions
- acute upper respiratory tract infection (wind heat syndrome) in children
- Registration Number
- ITMCTR2000003111
- Lead Sponsor
- Dongzhimen Hospital Beijing University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. It conforms to the diagnostic standard of Western medicine in children with acute upper respiratory tract infection;
2. Accord with syndrome differentiation standard of cold wind heat syndrome;
3. Aged >= 2 and < 13 years;
4. Course within 24 hours;
5. Fever before the first application (body temperature >= 37.3 degrees C and <= 38.5 degrees C);
6. The informed consent process is in accordance with the regulations, and the legal representative or the test child ( >= 8 years old) sign the informed consent together.
1. Children who have used other drugs to treat the disease (including cold medicine, antibiotics, antiviral drugs and similar traditional Chinese Medicine) within 24 hours before treatment;
2. Children with lower respiratory tract infection and infectious diseases such as bronchitis, bronchiolitis and pneumonia;
3. Total leukocyte count (WBC) >= 12 x10 ^9 / L or neutrophil absolute value (n) > 1.2 times the upper limit of reference value (ULN);
4. Children with history of epilepsy or febrile convulsion, children with recurrent respiratory tract infection;
5. Children with congenital immune deficiency, malnutrition, rickets, or other serious systemic diseases such as cardiovascular, brain, liver, kidney and hematopoietic system, among which ast, ALT > upper limit of reference value (ULN), bun > upper limit of reference value (ULN), SCR > upper limit of reference value (ULN);
6. Definitely diagnosed as children with mental development disorders;
7. Allergic constitution and children allergic to the test drug;
8. According to the judgment of researchers, it is easy to cause lost visitors.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical recovery time;
- Secondary Outcome Measures
Name Time Method Time of complete antipyretic;TCM syndrome integral;Disease recovery rate;Single symptom of traditional Chinese Medicine;