[Translation] An open, single-arm, self-controlled, multicenter phase IV clinical trial on the safety and efficacy of Wuwei Kushen Enteric-coated Capsules in the treatment of active ulcerative colitis
(1) 考察在广泛使用条件下的安全性和有效性; (2) 评价安全性,特别重点关注肝功能和心血管安全性; (3) 评价在普通、特殊人群中使用的利益与风险关系,评估风险因素,制定风险控制措施,完善管理计划; (4) 探索适宜的优势人群; (5) 进行风险/受益评估。
[Translation] (1) Examine the safety and effectiveness under conditions of widespread use; (2) Evaluate safety, with a particular focus on liver function and cardiovascular safety; (3) Evaluate the benefit-risk relationship of use in general and special populations, assess risk factors, develop risk control measures, and improve management plans; (4) Explore appropriate advantage populations; (5) Conduct a risk/benefit assessment.