[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical trial of Calendula officinalis oral ulcer patch in the treatment of recurrent aphthous ulcer (heart and spleen heat accumulation syndrome)
在Ⅱ期临床试验基础上,以靶溃疡愈合时间为主要指标,以安慰剂作对照,确证侧金盏口腔溃疡贴片治疗复发性阿弗他溃疡(心脾积热证)的有效性,并进一步评价其安全性及可能的不良反应,为本品的注册审查提供依据。
[Translation] On the basis of Phase II clinical trials, with target ulcer healing time as the primary indicator and placebo as the control, the effectiveness of the Aphrodisiac Oral Ulcer Patch in the treatment of recurrent aphthous ulcers (heart and spleen heat accumulation syndrome) was confirmed, and its safety and possible adverse reactions were further evaluated to provide a basis for the registration review of this product.