[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of Kangfuxin enteric-coated capsules combined with mesalazine in the treatment of mild to moderate active ulcerative colitis
以临床缓解率、临床有效率、内镜应答率、黏膜愈合率、组织学临床缓解率等为疗效指标,采用多中心、随机、双盲、安慰剂平行对照的临床试验设计,初步评估康复新肠溶胶囊联合美沙拉秦治疗轻、中度活动期溃疡性结肠炎的有效性及安全性。
[Translation] Using clinical remission rate, clinical effective rate, endoscopic response rate, mucosal healing rate, histological clinical remission rate and other efficacy indicators, a multicenter, randomized, double-blind, placebo-controlled clinical trial design was adopted to preliminarily evaluate the efficacy and safety of Kangfuxin Enteric-coated Capsules combined with mesalazine in the treatment of mild to moderate active ulcerative colitis.