[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical trial on the efficacy and safety of Changkang granules in the treatment of diarrhea-predominant irritable bowel syndrome
主要研究目的:初步评价肠康颗粒治疗腹泻型肠易激综合征的有效性和安全性,并进行中医证型的探索。 探索性研究目的:探索IBS受试者服用肠康颗粒后体内内源性物质变化,通过代谢组学及系统生物学方法阐明肠康颗粒的作用机理,同时寻找可能的临床生物标记物。
[Translation] The main purpose of the study is to preliminarily evaluate the efficacy and safety of Changkang Granules in the treatment of diarrhea-predominant irritable bowel syndrome and explore the TCM syndrome types. The purpose of the exploratory study is to explore the changes in endogenous substances in IBS subjects after taking Changkang Granules, to clarify the mechanism of action of Changkang Granules through metabolomics and systems biology methods, and to find possible clinical biomarkers.