Abstract: OBJECTIVE: To describe a protocol to assess the effects of Traditional Chinese Medicine(TCM) on patients with coronary heart disease(CHD) showing symptoms of phlegm-heat-stasis symptom pattern.METHODS: This is a single-blind randomized controlled trial that will be conducted in the First Teaching Hospital of Tianjin University of TCM and 60 patients with CHD showing phlegm-heat-stasis symptom pattern will be included. Patients will be randomly divided into either a treatment group(Qingre Huatan formulae + Western Medicine) or to acontrol group(conventional Western Medicine only) for 7-14 d. Primary patient outcomes will be vascular endothelial function and quality of life. Measurement data will be expressed as mean ± standard deviation using t-test analysis or repeated-measure variance analysis. Enumeration data will be expressed by cases and percentages, using χ~2 analysis, and rank sum test will be used for ranked data.RESULTS: This study further verified the effectiveness and safety of Qingre Huatan formulae for the phlegm-heat-stasis syndrome pattern of CHD on the basis of previous studies on the characteristics of syndromes and medication rules.DISCUSSION: Phlegm-heat-stasis symptom pattern has become a common manifestation in CHD.Standardized Western medications together with TCM have been extensively used in China and have developed into a comprehensive treatment model.Our trial will help formulate recommendations for symptom maintenance and provide clinical evidence for the application of TCM for patients with CHD showing phlegm-heat-stasis symptom pattern.

Key words: coronary disease, medicine,Chinese traditional, phlegm-heat-stasis, symptom complex, vascular endothelial function, quality of life, clinical trial protocol