[Translation] A randomized, double-blind, multicenter phase III clinical trial comparing Liwei capsule with Sanjiu Weitai 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] Primary purpose: To determine the disappearance rate of epigastric pain after taking the medicine for 28 consecutive days. Secondary purpose: To evaluate the disappearance rate of epigastric distension, the total effective rate of TCM symptom efficacy, the cure rate of gastric mucosal erosion under gastroscopy, the cure rate of overall efficacy of gastric mucosal lesions, the cure rate of active and chronic inflammatory histology, and the eradication rate of Hp in patients for 28 consecutive days, and to compare the safety of patients. To provide a basis for the review of registration applications.