A randomized, double-blind, parallel controlled, multi-center clinical trial of the effectiveness and safety of Qingke Pingchuan Granules in the treatment of children with acute bronchitis (phlegm-heat stagnation lung syndrome)

Shanghai Traditional Chinese Medicine Hospital0 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. Meet the diagnostic criteria of western medicine for acute bronchitis in children;
•2. TCM syndrome differentiation accords with phlegm-heat stagnation syndrome;
•3. 6 years old <= age <= 14 years old, no gender limit;
•4. Course of disease <= 48h;
•5. Parents or guardians voluntarily agree and sign the informed consent form, and the children = 8 years old participate in the informed consent and sign the informed consent form.

•1. Severe bronchitis and pneumonia are difficult to distinguish in the early stage;
•2. Suffer from acute infectious diseases such as measles, whooping cough and influenza;
•3. Children with acute upper respiratory tract infection, bronchial asthma, bronchiolitis, bronchopneumonia and other respiratory diseases;
•4. Children with acute attacks of chronic bronchitis;
•5. The total number of white blood cells > 12 x 10^9/L, and the percentage of neutrophils > 70%;
•6. Children with malnutrition and immunodeficiency;
•7. Children whose body temperature exceeds 38.0 degrees C;
•8. Liver function test values (ALT, AST) > upper limit of normal value, blood creatinine > upper limit of normal value;
•9. Those who are allergic to the test drug or its components;
•10. Children who have used antibiotics, cough-reducing and phlegm-resolving medicines and other Chinese and Western medicines that have an impact on cough within 24 hours before treatment;
•11. Combined with serious primary diseases such as severe heart, liver, kidney, digestive and hematopoietic system;
•12. According to the judgment of the investigator, there are other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as unstable living environment, inconvenient transportation, etc. that may easily cause loss to follow-up.

发起方

Shanghai Traditional Chinese Medicine Hospital