[Translation] A multicenter, prospective cohort design, phase IV clinical study of Jingxing cough granules in children for the treatment of acute bronchitis and post-infectious cough based on a real medical environment
观察小儿荆杏止咳颗粒在真实医疗环境下的有效性与安全性,为该药临床推广应用提供支持,为变更适用人群、增加功能主治提供探索性依据,同时为该药品再注册提供安全性和有效性证据。(1)观察该药治疗 1~14 岁儿童急性支气管炎风寒化热证的有效性与安全性;(2)观察该药治疗 3~14 岁儿童感染后咳嗽(PIC)风寒化热证的有效性与安全性。
[Translation] To observe the effectiveness and safety of Jingxing Antitussive Granules for Children in a real medical environment, provide support for the clinical promotion and application of the drug, provide exploratory basis for changing the applicable population and adding functional indications, and provide safety and effectiveness evidence for the re-registration of the drug. (1) To observe the effectiveness and safety of the drug in the treatment of wind-cold-heat syndrome of acute bronchitis in children aged 1 to 14 years; (2) To observe the effectiveness and safety of the drug in the treatment of wind-cold-heat syndrome of post-infectious cough (PIC) in children aged 3 to 14 years.