A pilot trial is an important prerequisite to ensure the success of high-quality clinical trials

and it can also provide references for future sample size estimate of larger full-scale trilas. This study aimed to explain the purpose and significance of conducting a pilot trial in TCM. By fully considering the characteristics of TCM clinical trials

and taking randomized controlled trials（RCTs） as an example

this study discussed how to determine the sample size of pilot trials from the perspectives of feasibility

precision

minimization of total sample size and standardized effect size.