功能性腹痛是學齡期兒童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。在參考國內外最新診療方法、專業(yè)權威著作、最新學術進展的基礎上，結合本機構多年的臨床試驗設計與實踐經驗，重點介紹了中藥治療兒童功能性腹痛的臨床研究策略、設計與評價的技術要點，以期為治療該病的中藥臨床試驗設計提供參考。

Functional abdominal pain is one of the most common problems in functional gastrointestinal disorders, and it's also one of the diseases benefit most from traditional Chinese medicine (TCM) treatment. This paper illustrates some key considerations on the study design of traditional Chinese medicine intended for the treatment of FAP based on the latest treatment and evaluation guidelines, technical guidance, professional authority works as well as the latest clinical studies, and combined with experience of clinical trial design. It hopes to offer helps for research designers in this genera.