功能性便秘是兒童時期常見的功能性胃腸病，也是中醫(yī)藥治療的優(yōu)勢病種之一。在病證結(jié)合的模式下，以臨床價值為導(dǎo)向，基于國內(nèi)外最新的診療指南、研究進(jìn)展、權(quán)威專著，結(jié)合本機(jī)構(gòu)的臨床經(jīng)驗，重點介紹中藥治療兒童功能性便秘的臨床試驗設(shè)計、研究策略及評價方法，以期為中藥治療兒童功能性便秘臨床試驗提供方法學(xué)參考。

Functional constipation (FC) is a common functional gastrointestinal disease among children, and it's also one of the diseases benefit most from Chinese materia medica (CMM) treatment. Based on the mode of syndrome combined disease, clinical value oriented, as well as the latest research progress in the diagnosis and treatment of guidelines, and authoritative monograph, combined with the agency's clinical experience, this paper focus on the study design of CMM intended for the treatment of FC, research strategies and evaluation methods, so as to provide methodological reference for the clinical trial of CMM in the treatment of functional constipation in children.