Abstract: Clinical predictive modelling refers to the use of multifactorial models to predict the probability of having a certain disease or the occurrence of a certain outcome in the future. In recent years, studies related to predictive modelling in the field of traditional Chinese medicine (TCM) have gradually emerged, and the construction of TCM clinical predictive models can assist TCM physicians in clinical diagnosis and evidence-based decision-making. An appropriate sample size is essential to improve the accuracy and credibility of clinical prediction models. Insufficient sample size may result in failure to obtain statistically significant conclusions, while too large a sample size may result in a waste of resources. This study analyses the current situation regarding sample size estimation methods for clinical prediction models in the field of traditional Chinese medicine, and discusses in depth the sample size estimation methods, including the 10 Events Per Variable (10EPV) principle, the 10 Events Per Predictor (10EPP) rule, and the four-step method. sample size estimation method for clinical prediction models, and also demonstrated by examples. The aim of this study is to provide a practical reference for the sample size estimation of clinical prediction models, in order to promote the research related to clinical prediction models in the field of Chinese medicine.