Multi-center randomized controlled clinical study of Saffron Yellow Sterile Powder for Injection for the treatment of stable angina pectoris with heart-blood stagnation syndrome in patients

AIM To evaluate the efficacy and safety of Saffron Yellow Sterile Powder for Injection(SYSPI) for the treatment of stable angina pectoris with heart-blood stagnation syndrome in patients.METHODS A multi-center,randomized,single-blind,parallel to the positive drug control clinical trial was carried out in 220 patients.Patients were randomly divided into two groups: test group received SYSPI(250 mg) in 0.9% NaCl 100 mL(n=110),and the control group received Honghua Injection 15 mL in 5% glucose injection 250 mL(n=110).After 14-day treatment,the efficacy and safety of SYSPI were evaluated.RESULTS The points of heart-blood stagnation syndrome of two groups were significantly lower than those before treatment(P0.05).There was no significant difference between the two groups in total effective rate based on traditional Chinese medicine syndrome(P0.05).There was no significant difference between the two groups in total effective rate based on angina pectoris analyzed(P0.05).The points of angina pectoris of the two groups were significantly lower than those before treatment(P0.05).There was no significant difference between the two groups in effective rate of reduction or stop of nitroglycerin and ECG(P0.05).The incidence of adverse events in the two groups was 2.8% and 3.7%,respectively,and there was no significant difference between the two groups(P0.05).CONCLUSION SYSPI is effective and safe for the treatment of stable angina pectoris with heart-blood stagnation syndrome in patients with coronary heart disease.