[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of Huang's Sound Spray (Children's Type) in patients with acute pharyngitis (exogenous wind-heat syndrome)
主要目的:在咽痛(吞咽痛)的严重程度达到WBS≥4分的急性咽炎(外感风热证)参与者中,接受黄氏响声喷雾剂(儿童型)治疗3天后在疼痛消失率上与安慰剂治疗是否有差异。
次要目的:(1)评价黄氏响声喷雾剂(儿童型)的治疗对急性咽炎(外感风热证)参与者的症状和体征改变的影响;(2)评价黄氏响声喷雾剂(儿童型)治疗急性咽炎(外感风热证)的安全性。
[Translation] Primary objective: To investigate whether the pain-free rate after 3 days of treatment with Huang's Sound Spray (Children's Type) is different from that of placebo in participants with acute pharyngitis (exogenous wind-heat syndrome) whose pharyngeal pain (dynophagia) is as severe as 4 points on the WBS. Secondary objectives: (1) To evaluate the effect of Huang's Sound Spray (Children's Type) on the changes in symptoms and signs of participants with acute pharyngitis (exogenous wind-heat syndrome); (2) To evaluate the safety of Huang's Sound Spray (Children's Type) in the treatment of acute pharyngitis (exogenous wind-heat syndrome).