[Translation] A randomized, double-blind, dose-controlled, multicenter phase II clinical trial on the efficacy and safety of Zhenzhu Drop Pills in the treatment of recurrent oral ulcers (heart and spleen heat accumulation syndrome)
从靶溃疡愈合率、愈合时间、疼痛消失率、疼痛消失时间等方面,初步评价珍珠滴丸治疗复发性口腔溃疡(心脾积热证)的有效性及安全性,同时进行剂量探索,初步评价剂量与疗效及安全性的关系,为下一阶段临床试验设计提供依据。
[Translation] The effectiveness and safety of Pearl Drops in the treatment of recurrent oral ulcers (heart and spleen heat accumulation syndrome) were preliminarily evaluated in terms of target ulcer healing rate, healing time, pain disappearance rate, pain disappearance time, etc. At the same time, dose exploration was carried out to preliminarily evaluate the relationship between dose and efficacy and safety, providing a basis for the design of the next stage of clinical trials.