YFZ-003治疗小儿急性扁桃体炎(风热证)有效性和安全性的随机、双盲双模拟、三臂平行对照、多中心Ⅱ期临床试验
[Translation] A randomized, double-blind, double-dummy, three-arm parallel-controlled, multicenter phase II clinical trial to investigate the efficacy and safety of YFZ-003 in treating acute tonsillitis (wind-heat syndrome) in children.
主要目的:在 3~13 岁小儿急性扁桃体炎(风热证)患儿中,治疗 5~7 天,以咽痛(吞咽痛)消失率为主要终点,比较YFZ-003与极低剂量YFZ-003是否有差异、原工艺YFZ-003与极低剂量YFZ-003是否有差异,YFZ-003是否非劣于原工艺YFZ-003,并进行疗程探索。
次要目的:在3~13岁小儿急性扁桃体炎(风热证)患儿中,治疗5~7天,探索咽痛(吞咽痛)消失时间、WBS评分较基线变化值、止痛起效时间、咽部体征消失率、完全退热时间、疾病痊愈率、中医证候疗效及中医证候积分较基线变化值、单项症状消失率等方面,各组间两两相比是否有差异;观察临床应用的安全性。
[Translation] Primary Objective: In children aged 3–13 years with acute tonsillitis (wind-heat syndrome), after 5–7 days of treatment, with the primary endpoint being the disappearance rate of sore throat (painful swallowing), this study aims to compare the differences between YFZ-003 and very low-dose YFZ-003, and between the original process YFZ-003 and very low-dose YFZ-003, and to determine whether YFZ-003 is non-inferior to the original process YFZ-003, and to explore the duration of treatment.
Secondary Objectives: In children aged 3–13 years with acute tonsillitis (wind-heat syndrome), after 5–7 days of treatment, this study aims to explore the following aspects: disappearance time of sore throat (painful swallowing), change in WBS score from baseline, time to onset of analgesia, disappearance rate of pharyngeal signs, time to complete fever reduction, disease cure rate, efficacy of TCM syndrome differentiation and change in TCM syndrome score from baseline, and disappearance rate of individual symptoms. Pairwise comparisons between groups are also necessary to observe the safety of clinical application.
/ Not yet recruitingPhase 4IIT A randomized controlled multi-center trial for Xiao'er Jin Qiao granules in the treatment of influenza(wind heat syndromes) in child
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