RESUMO
ObjectiveTo effectively organize the interdisciplinary knowledge of traditional Chinese medicine （TCM） and evidence-based medicine contained in the clinical trial literature of TCM and facilitate the processing and mapping of multi-source data， this paper organized the knowledge of clinical trial literature of TCM by ontology modeling. MethodThe seven-step method and skeleton method were used to develop the ontology. After the structure and language characteristics of TCM clinical trial literature were analyzed， the ontological and non-ontological resources such as top-level framework of Scientific Evidence and Provenance Information Ontology （SEPIO） and TCM language system （TCMLS） were reused to determine the domain concepts and attribute relationship. Finally， the core concepts and attribute relationship such as disease， syndrome， symptom， grouping， intervention measures， outcome indicators and literature quality information were determined. ResultThe information contained in the clinical trial literature of TCM was divided into five categories. According to the Cochrane risk of bias assessment tool and CONSORT 2010 statement， the literature quality evaluation information was mapped to the ontology， and a total of 68 categories， 8 object attributes， and 38 data attributes were established， which basically realized the structured expression of clinical trial literature. ConclusionThe ontology of TCM clinical trial literature constructed in this study can well organize， utilize， and present the construction and association of internal knowledge system in TCM clinical trial literature， underpinning the reasoning of strength of evidence and information of diagnosis and treatment in the future.