[Translation] A randomized, double-blind, double-dummy, dose-exploration, parallel-controlled, multi-center phase II clinical trial of the efficacy and safety of Qingchang Wenzhong Tablet in the treatment of moderately active ulcerative colitis (mixed cold and heat, damp-heat stasis syndrome)
采用随机、双盲双模拟、剂量探索、阳性药平行对照、多中心临床试验设计,初步评价清肠温中片治疗中度活动期溃疡性结肠炎(寒热错杂、湿热瘀阻证)的有效性和安全性,探索清肠温中片对溃疡性结肠炎患者诱导缓解的作用,并为确证性临床试验提供数据支持。
[Translation] A randomized, double-blind, double-dummy, dose-exploration, active-drug parallel-controlled, multi-center clinical trial design was used to preliminarily evaluate the efficacy of Qingchang Wenzhong Tablet in the treatment of moderately active ulcerative colitis (mixed cold and heat, damp-heat stasis syndrome) and safety, explore the effect of Qingchang Wenzhong Tablet in inducing remission in patients with ulcerative colitis, and provide data support for confirmatory clinical trials.