[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial on the efficacy and safety of Lianxia Xiaopi granules in the treatment of functional dyspepsia (cold-heat syndrome)
主要研究目的:初步评价连夏消痞颗粒治疗功能性消化不良(寒热错杂证)的有效性和安全性,为后期临床试验提供依据。
探索性研究目的:探索服药前后体内内源性物质及免疫指标的变化,通过组学研究方法(包括代谢组学、蛋白组学、免疫组学中一项或多项组学研究)及系统生物学方法阐释药物作用机理,同时寻找潜在的临床生物标志物,用于临床试验的探索性亚组分析。
[Translation] Main research purpose: To preliminarily evaluate the efficacy and safety of Lianxia Xiaopi Granules in the treatment of functional dyspepsia (cold-heat syndrome) and provide a basis for later clinical trials.
Exploratory research purpose: To explore the changes in endogenous substances and immune indicators before and after medication, to explain the mechanism of drug action through omics research methods (including one or more omics studies in metabolomics, proteomics, and immunoomics) and systems biology methods, and to find potential clinical biomarkers for exploratory subgroup analysis of clinical trials.