To provide a reference for the design of traditional Chinese medicine(TCM) clinical trials for acute tracheobronchitis by systematically analyzing the current application of outcome measures in randomized controlled trials(RCTs) of TCM treatment for this condition.Methods:A computer-based search was conducted across eight Chinese and English databases and two clinical trial registries for RCTs of TCM treatment for acute tracheobronchitis published over the past ten years.Two researchers independently performed literature screening,data extraction,and risk-of-bias assessment,followed by a systematic analysis of the application of outcome measures.Results:A total of 77 studies were included,involving 57 types of outcome measures reported 417 times in total.The top five most frequently used outcomes were clinical efficacy,adverse events,TCM syndrome score,cough symptom score,and safety indicators.Fifty studies reported Western medicine diagnostic criteria,42 studies reported TCM syndrome differentiation criteria,19 studies specified primary outcome measures,and only 5 studies reported standards for evaluating the efficacy of TCM syndromes.Conclusion:The application of outcome measures revealed several issues,including unclear distinction between primary and secondary outcomes,inconsistency in TCM syndrome differentiation and efficacy evaluation standards,insufficient reporting of safety and economic indicators,and inadequate attention to patient-reported outcomes.It is recommended that future clinical trials clearly differentiate primary and secondary outcomes,reasonably select TCM syndrome differentiation standards,establish scientific criteria for evaluating TCM syndrome efficacy,and emphasize the reporting of safety,economic,and patient-reported outcome indicators