Coronary atery disease
Conditions
Interventions
SQSX group:Conventional treatment plus Shenqisuxin Granule, twice a day, 61 days
control group:Conventional treatment plus placebo, twice a day, 61 days
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Diagnosed as complex coronary artery lesions, when coronary angiography includes at least one of the following conditions: a.bifurcation lesions (side branch diameter>2.0mm); b.excessive tortuosity of proximal segment; c.severe coronary artery calcification; d.chronic total occlusion lesions (>3 months); e.left main lesions; f.aorto-ostial lesions; g.diffuse lesions (>20mm length); h.multivessel coronary artery stenosis (=2 two vessels); i.extremely angulated lesions(>90°bend); j.in-stent restenosis. (2) Diagnosed as stable angina of coronary atery disease; (3) NYHA function grade I-?; (4) Within 2 years after PCI, and at least one coronary stent has been implanted; (5) 18 ~ 75 years old; (6) Diagnosed as TCM syndrome of heart and spleen deficiency; (7) The patient did not take antibiotics, hormones, laxatives, antidiarrheal drugs, and probiotics within 3 months before enrollment; (8) Written informed consent is obtained.
Exclusion criteria
Exclusion criteria: (1) Indication of renal insufficiency with serum creatinine >220umo/l in men or >175umo/l in women; (2) Severe liver disease or ALT and AST both 3 times above the upper limit of normal; (3) Controlled systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg; (4) Diabetic patients with random blood glucose = 13.7 mmol/L or glycosylated hemoglobin = 9.5%; (5) Women who are pregnant or planning to become pregnant, or who are breastfeeding; (6) Severe acute or chronic cerebrovascular disease; (7) Malignancies; (8) Severe hematopoietic disorders; (9) Severe mental illness; (10) Inflammatory or malabsorptive intestinal disorders; (11) Patients who have participated within the last three months or are participating in other clinical trials;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak VO2/kg;MET; | — |
Secondary
| Measure | Time frame |
|---|---|
| High sensitivity C-reactive protein;Trimethylamine N-oxide;MACCE;HAMA;Seattle Angina scale;EQ-5D-5L;stasis syndrome score of CAD;Bleeding events;Fatigue severity Scale; | — |
Countries
China
Contacts
Public ContactPeili Wang
National Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed