[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial to evaluate the efficacy and safety of Fengye Kechuanping oral liquid (children's type) in the treatment of acute bronchitis (wind-heat cough syndrome) in children.
(1)初步评价风叶咳喘平口服液(儿童型)治疗小儿急性支气管炎(风热咳嗽证)缓解支气管炎病情/症状体征、缩短病程和改善中医证候作用。
观察指标:支气管炎严重程度评分(BSS)及其症状体征因子分,咳嗽症状积分,临床疗效总评-病情改善程度,咳嗽起效时间/率,咳嗽消失时间/率,中医证候疗效。
(2)观察风叶咳喘平口服液(儿童型)临床应用的安全性。
观察指标:不良事件/不良反应发生率,生命体征,实验室检查等。
[Translation] (1) To preliminarily evaluate the effect of Fengye Kechuanping oral liquid (children's type) in treating acute bronchitis (wind-heat cough syndrome) in relieving bronchitis symptoms/symptoms and signs, shortening the course of the disease, and improving TCM syndromes in children.
Observation indicators: Bronchitis severity score (BSS) and its symptom and sign factor score, cough symptom score, clinical efficacy summary-degree of improvement, cough onset time/rate, cough disappearance time/rate, TCM syndrome efficacy.
(2) To observe the safety of Fengye Kechuanping oral liquid (children's type) in clinical application.
Observation indicators: incidence of adverse events/adverse reactions, vital signs, laboratory tests, etc.