Objective: To refine and evaluate the clinical evidence, and provide proof and reference for Xinxuening's clinical program establishment from the perspective of evidence-based medicine through screening the clinical studies of cardiovascular disease by Xinxuening.s treatment. Method: The included and excluded criteria was established before the setting of search terms, eligible databases (PubMed, Web of Science, Ovid, Embase, Cochrane, CNKI, CBM, Wanfang and Vip) were searched and the quality evaluation and evidence classification was conducted for eligible documents. The software RevMan was used to evaluate the clinical evidence of Xinxuening in the treatment of cardiovascular disease (primary hypertension, coronary heart disease, heart failure and hyperlipidemia) and to explore the specific mechanism.Results: A total of 16 suitable studies were included, of which 15 were RCTs and 1 was observation study. 9 of the 16 studies were the C level evidence and 7 were the D level. The included studies were all low quality. The outcome indicators of clinical treatment for cardiovascular disease were: the efficacy of hypertension therapy, the level of systolic and diastolic blood pressure after therapy, the efficacy of angina pectoris and hyperlipidemia treatment, and the total cholesterol and triglyceride levels after treatment. The results showed that Xinxuening could significantly reduce the level of blood pressure for patients with hypertension, improve the symptoms of angina pectoris in patients with coronary heart disease, and reduce the levels of blood lipids (triglycerides and total cholesterol) . The results have statistical differences (P ＜ 0.05) . However, it the specific mechanism of Xinxuening in the treatment of cardiovascular disease was not found.Conclusion: Xinxuening has higher clinical effect on the treatment of some cardiovascular diseases compared with some western drugs and other proprietary Chinese medicine. However, it still needs further exploration of the specific clinical mechanism and to conduct high-quality clinical research.