Chronic Coronary syndrome (CCS)
Conditions
Interventions
Experimental Group:Xiaoyu Jiangzhi capsule
Control group:Xiaoyu Jiangzhi capsule placebo
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old =3 months or coronary artery bypass grafting (CABG) >=12 months before enrollment; Coronary angiography (CAG) or coronary CT angiography (CTA) confirmed stenosis of at least 50% (or moderate or greater) in at least one major coronary artery (left main coronary artery, left anterior descending artery, left circumflex artery, right coronary artery). 3. hs-CRP>=2 mg/L; 4. sign the informed consent and can cooperate with the relevant tests, examinations and follow-up.
Exclusion criteria
Exclusion criteria: 1. hs-CRP > 10 mg/L or other comorbidities that may affect hs-CRP levels, such as peripheral neuritis, myocarditis, chronic inflammatory diseases (such as rheumatoid arthritis, inflammatory bowel disease, chronic infection, chronic kidney disease, etc.), Acute inflammatory diseases (such as upper respiratory tract infection, urinary tract infection, acute gastroenteritis, etc.) or persistent febrile illness within the past 2 weeks, or other diseases that may be affected by the investigator's judgment; 2. patients with a history of myocardial infarction, stroke, severe trauma, or major surgery within 3 months before admission; 3. planned to undergo any arterial revascularization (coronary, peripheral, or carotid) or any other procedure during the study treatment period; 4. cardiogenic shock, refractory ventricular arrhythmia or severe heart failure (ejection fraction 3 times the upper limit of the reference value; b. Renal injury: serum creatinine (Scr) > 1.5 times the upper limit of reference value or glomerular filtration rate (eGFR) <30 mL/(min×1.73 m²); 10. use of colchicine, non-steroidal anti-inflammatory drugs (except aspirin and indobuphin), antibiotics, topical corticosteroids (including percutaneous, intranasal, intraocular, and articular) within 2 weeks before screening, or systemic corticosteroids or immunosuppressants within 30 days before screening; 11. taking any Chinese medicine or patent Chinese medicine within 2 weeks before screening; 12. known allergic to the trial drug or its components; 13. with a long history of alcohol and drug abuse; 14. women who are pregnant or lactating or women/men who are planning to give birth, or the subject does not consent to use a medically approved method of contraception during the study treatment and for 6 months after the last dose; 15. patients who had participated in another drug clinical trial within 3 months before enrollment; 16. who were deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hs-CRP; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiovascular and Cerebrovascular Events?, MACCE;Quality of life Scores;Blood lipid indicators (LDL-C, TC, TG, HDL-C, non-HDL-C, Lp(a));MPO, IL-6;Neutrophil count and NLR were calculated; | — |
Countries
China
Contacts
Public ContactHe Ben
Shanghai East Hospital
Outcome results
None listed