利胃胶囊与三九胃泰胶囊对照治疗慢性非萎缩性胃炎伴糜烂(湿热瘀滞证)的随机、双盲、多中心III期临床试验
[Translation] A randomized, double-blind, multicenter phase III clinical trial of Liwei Capsule and Sanjiuweitai Capsule in the treatment of chronic non-atrophic gastritis with erosion (damp-heat stasis syndrome)
主要目的:确定连续服药28天后胃脘疼痛消失率。 次要目的:评价连续28天患者胃脘痞胀消失率、中医症候疗效总有效率、胃镜下胃黏膜糜烂痊愈率、胃黏膜病变总体疗效痊愈率、活动性和慢性炎症组织学的痊愈率、Hp根除率是否相同,并比较患者的安全性。为注册申请的审查提供依据。
[Translation] Main purpose: To determine the disappearance rate of epigastric pain after 28 days of continuous medication. Secondary objective: To evaluate the disappearance rate of epigastric distention in patients for 28 consecutive days, the total effective rate of TCM symptoms, the recovery rate of gastric mucosal erosion under gastroscopy, the overall curative effect recovery rate of gastric mucosal lesions, the recovery rate of active and chronic inflammation histology, Whether the Hp eradication rate is the same, and compare the safety of patients. Provide a basis for the review of registration applications.
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