Objective To investigate the effectiveness and safety of Xuefu Zhuyu Capsule（ 血府逐瘀胶囊） on qi stagnation and blood stasis syndrome. Methods A total of 120 participants with qi stagnation and blood stasis syndrome from 3 hospitals were enrolled in this prospective center stratified block randomization

placebo controlled parallel

double blinded clinical trial. The treatment group（ 60 participants） was given Xuefu Zhuyu Capsule

while the control group（ 60 participants） was given simulant of Xuefu Zhuyu Capsule. Both groups were given 6 capsules each time

twice daily

7 weeks as a treatment course. The syndrome improvement of qi stagnation and blood stasis syndrome was evaluated based on Patient-reported qi Stagnation and Blood Stasis Syndrome Scale（ qi Stagnation and Blood Stasis Syndrome PRO scale） in 2

4

6

and 7 weeks’ intervention

and those were taken as primary outcomes to evaluate clinical efficacy. The secondary outcomes included improvement of related symptoms and signs of qi stagnation and blood stasis syndrome. Safety outcomes included blood routine

urinalysis

stool routine + occult blood

liver and kidney function

coagulation function and electrocardiogram. Results The treatment group demonstrated a significantly greater reduction in qi Stagnation and Blood Stasis Syndrome PRO Scale score than the control group after 7 weeks’ treatment（ P < 0. 05）. Xuefu Zhuyu Capsule significantly improved the pain

chest tightness

palpitation

rib-side distention

abdominal distension

sighing

insomnia

dizziness

numbness

dark complexion

purple lips

dark purple tongue

tongue image and pulse better than the placebo（ P < 0. 05）

and there was no statistically significant difference between the 2 groups in improving irritation and lump when compared with the placebo（ P >0. 05）. Stool routine showed stronger heterogeneity（ Kappa = 0. 06

P = 0. 384） before and after treatment

and blood routine

liver and kidney function

coagulation function

urine routine

urine biochemistry

electrocardiogram showed homogeneity before and after treatment（ P < 0. 01）. Conclusion Xuefu Zhuyu Capsule can effectively improve the qi stagnation and blood stasis syndrome with good clinical safety.