[Translation] A multicenter, randomized, double-blind, positive-drug parallel-controlled phase II clinical study to evaluate the efficacy and safety of Pudinghewei Capsule in the treatment of chronic non-atrophic gastritis
主要目的:初步评价患者连续服药14天后胃脘胀或(和)痛、口黏且苦症状消失率以及药物的安全性。 次要目的: 初步评价连续14天患者中医症候疗效总有效率、幽门螺旋杆菌(Hp)清除率。 为药物Ⅲ期临床研究方案的确定提供依据。
[Translation] Primary purpose: To preliminarily evaluate the disappearance rate of epigastric distension or (and) pain, sticky and bitter mouth symptoms and the safety of the drug after patients took the drug for 14 consecutive days. Secondary purpose: To preliminarily evaluate the total effective rate of TCM symptoms and Helicobacter pylori (Hp) clearance rate of patients for 14 consecutive days. To provide a basis for the determination of the Phase III clinical research plan of the drug.