OBJECTIVETo observe the clinical efficacy and safety of Xinluotong Tablet (XLTT, with actions of benefiting qi, activating blood, and supplementing Shen) in treatment of stable coronary heart disease angina patients of qi deficiency and blood stasis syndrome.

METHODS240 stable coronary heart disease angina patients of qi deficiency and blood stasis syndrome were randomly assigned to the trial group and the control group, 120 in each group. The trial group was treated with XLTT, four tablets each time, three times a day, while the control group was treated with Yangxinshi Tablet (YXST), three tablets each time, three times a day. The double blinded treatment lasted for four weeks. The therapeutic effects on angina, electrocardiogram (ECG), the exercise test, the improvement of Chinese medicine syndromes, and the safety index were observed.

RESULTSThe trial group was superior to the control group after treatment in aspects of the therapeutic effects on angina (91.45% vs 84.87%) and the ECG (65.81% vs 55.46%), but with no statistical difference (P>0.05). There was no statistical difference in the the exercise test or the improvement of Chinese medicine syndromes (P>0.05). No adverse reaction occurred during the therapeutic course.

CONCLUSIONXLTT was safe and effective in treatment of stable coronary heart disease angina patients of qi deficiency blood stasis syndrome.