[Translation] A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial on the efficacy and safety of Jianwei Qutong Pills in the treatment of chronic non-atrophic gastritis (spleen and stomach qi deficiency with damp-heat stasis syndrome)
以用药8周后慢性非萎缩性胃炎症状应答有效率为主要疗效指标,与安慰剂对照,在II期临床试验基础上,进一步研究和评价健胃祛痛丸治疗慢性非萎缩性胃炎(脾胃气虚兼湿热瘀滞证)的有效性和安全性,最终为药物注册申请提供充分依据。
[Translation] Taking the effective rate of symptom response of chronic non-atrophic gastritis after 8 weeks of medication as the main efficacy indicator, compared with placebo, on the basis of Phase II clinical trials, further study and evaluate the effectiveness and safety of Jianwei Qutong Pills in the treatment of chronic non-atrophic gastritis (spleen and stomach qi deficiency with damp-heat and blood stasis syndrome), ultimately provide sufficient basis for drug registration application.