[Translation] A randomized, double-blind, parallel-controlled, phase II clinical trial to evaluate the efficacy and safety of Canghuo Pingwei Granules in the treatment of chronic superficial gastritis (spleen and stomach damp-heat syndrome)
进行苍藿平胃颗粒治疗慢性浅表性胃炎(脾胃湿热证)消化不良症状8周后患者有效性和安全性的Ⅱ期临床研究,为Ⅲ期临床研究提供依据。 主要研究目的: 采用安慰剂对照,评价苍藿平胃颗粒治疗慢性浅表性胃炎(脾胃湿热证)消化不良症状有效性。 次要目的:通过评价两组间不良事件发生率,比较试验组与对照组安全性指标的差异。
[Translation] A Phase II clinical study was conducted to evaluate the effectiveness and safety of Canghuo Pingwei Granules in treating dyspepsia symptoms of chronic superficial gastritis (spleen and stomach damp-heat syndrome) after 8 weeks, to provide a basis for Phase III clinical studies. Main purpose of the study: To evaluate the effectiveness of Canghuo Pingwei Granules in treating dyspepsia symptoms of chronic superficial gastritis (spleen and stomach damp-heat syndrome) by placebo control. Secondary purpose: To compare the differences in safety indicators between the experimental group and the control group by evaluating the incidence of adverse events between the two groups.