As traditional Chinese medicine (TCM) attach importance to clinic, shortage of objective and quantitative criteria in evaluating therapeutic effect is one of the largest obstacles for TCM to move toward the world and win wide approval. The introduction of evidence-based medicine (EBM) concept brings favorable opportunity to research on TCM. The authors have conducted clinical studies on restenosis after percutaneous coronary intervention (PCI) intervened by TCM, in the period of Tenth Five-Year Project, and realized EBM was indeed a vital principle for clinical study on TCM. However, randomized controlled trial should be applied reasonably, attention should be paid to the standardized design of research, including estimation of sample size, concealment of randomized sequence, extension of blindness and selection of control, and stress should be put on the quality control in implementation, so as to provide objective evidence for effect evaluation of TCM treatment.