[Translation] A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial of Qingyan Lihou capsule in the treatment of acute pharyngitis (lung and stomach heat syndrome)
主要目的:
以用药结束后疾病痊显率为评价指标,评价清咽利喉胶囊与安慰剂比较治疗急性咽炎(肺胃热盛证)的有效性。
次要目的:
(1)以咽痛消失率、咽痛消失时间、VAS评分、中医证候单项症状消失率、中医证候积分和咽部体征为评价指标,评价清咽利喉胶囊与安慰剂比较治疗急性咽炎(肺胃热盛证)的有效性。
(2)评价清咽利喉胶囊与安慰剂比较治疗急性咽炎(肺胃热盛证)的安全性。
[Translation] Main purpose:
Using the disease recovery rate after the end of medication as an evaluation index, to evaluate the effectiveness of Qingyan Lihou Capsule compared with placebo in the treatment of acute pharyngitis (lung and stomach heat syndrome).
Secondary purpose:
(1) Using the rate of disappearance of pharyngitis, time of disappearance of pharyngitis, VAS score, disappearance rate of single symptom of TCM syndrome, TCM syndrome score and pharyngeal signs as evaluation indicators, to evaluate the effectiveness of Qingyan Lihou Capsule compared with placebo in the treatment of acute pharyngitis (lung and stomach heat syndrome).
(2) To evaluate the safety of Qingyan Lihou Capsule compared with placebo in the treatment of acute pharyngitis (lung and stomach heat syndrome).