To confirm the efficacy and safety of Wufuxinnaoqing Soft Capsule (五福心脑清胶囊

WSC) in the treatment of chronic stable angina (blood stasis syndrome). A multicenter

randomized

double-blind

placebo-controlled trial with superiority test was designed. A total of 240 patients with chronic stable angina (blood stasis syndrome) from multiple centers were randomly and equally assigned to the treatment group and the control group. Based on standard treatment of Western medicine

the treatment group was given WSC

while the control group was given WSC mimetic

both for 12 weeks. Observed indicators included the efficacy in angina

the efficacy in Chinese medicine syndrome

the withdrawal or reduce rate of nitroglycerin and routine safety indices. After 12-week treatment

the significant effective rate and total effective rate of the treatment group were significantly better than those of the control group (23.5% vs. 9.2%

64.7% vs. 30.8%)

respectively

with statistically significant difference (P<0.01). After 12-week treatment

the decreased points and the decreased rate of angina symptom score in the treatment group were better than in the control group (5.1±4.2 points vs. 2.8±3.5 points

44.9%±37.2% vs. 25.4%±30.7%) respectively

with significant difference (P<0.01). After 12-week treatment

the significant effective rate and total effective rate of the treatment group were better than the control group (respectively

30.3% vs. 15.0%

67.2% vs. 45.0%

P<0.01). After 8- or 12-week treatment

the decreased points and the decreased rate of Chinese medicine syndrome score in the treatment group were better than the control group (P<0.05 orP<0.01). After 12-week treatment

nitroglycerin withdrawal rate and the withdrawal or reduce rate in treatment group were better than the control group (P<0.01). On safety evaluation

the incidence of adverse events (7.563% vs. 7.500%) and the incidence of cardiovascular events (0.840% vs. 0.000%) in the treatment group were similar with the control group

and the difference was not statistically significant (P>0.05). In treatment of chronic stable angina (blood stasis syndrome)

WSC can reduce angina attacks and consumption of nitroglycerin

decrease angina severity degree

effectively relieve the blood stasis syndromes

such as chest pain

chest tightness

palpitations

dark purple tongue and other symptoms. Besides

adverse events and cardiovascular adverse events in the treatment group and the control group showed no difference. All shows that the drug is safe and effective. [This study was registered in Chinese Clinical Trial Registry (ChiCTR)

with registration number: ChiCTR-TRC-14005158.]