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 children

Dongzhimen Hospital Beijing University of Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•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.

发起方

Dongzhimen Hospital Beijing University of Chinese Medicine