功能性腹痛是学龄期儿童常见的功能性胃肠病，也是中医药治疗的优势病种之一。在参考国内外最新诊疗方法、专业权威著作、最新学术进展的基础上，结合本机构多年的临床试验设计与实践经验，重点介绍了中药治疗儿童功能性腹痛的临床研究策略、设计与评价的技术要点，以期为治疗该病的中药临床试验设计提供参考。

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.