Coronary Atherosclerosis
Conditions
Interventions
treatment group:2 capsules of Xuesaitong Soft Capsules orally, twice daily.
control group:Standard preventive measures for coronary atherosclerosis, including plaque stabilization, antiplatelet therapy, and blood pressure control.
Sponsors
The first people's hospital of Yunnan Province
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) The subject has voluntarily signed the informed consent with his/her own approval, and is willing and able to comply with the scheduled visits, study treatment, laboratory tests, imaging examinations, and other study procedures. (2) Age 40–70 years, no gender restriction. (3) Confirmed by coronary computed tomography angiography (CCTA) or coronary angiography (CAG): coronary artery wall thickening, calcification, luminal stenosis (stenosis degree 90°, or presence of cholesterol crystals, macrophages, microchannels, healed plaque, vasa vasorum). (4) TCM syndrome presents as Blood Stasis Syndrome: Major symptoms: Stabbing pain with fixed location and tenderness; venous congestion (e.g., purplish lips, gums, nails, spider nevi, or exposed distended abdominal veins); subcutaneous ecchymosis; abdominal mass; bleeding outside the vessels; purplish dark tongue or tongue with ecchymosis/petechiae; distended sublingual veins; rough pulse, absent pulse, deep-stringy pulse, or stringy-slow pulse. Minor symptoms: Dry and scaly skin; numbness or hemiplegia; dementia, mania, or poor memory; abnormal local sensation; history of trauma, surgery, or induced abortion. Diagnostic criteria: 2 major symptoms, or 1 major symptom + 2 minor symptoms. (5) Has signed this informed consent, is able to comply with the study visits, examinations and treatment procedures, and demonstrates good compliance. (6) Meets the auxiliary diagnostic criteria for coronary atherosclerosis in combination with risk factors including hypertension, hyperlipidemia, diabetes mellitus, smoking, obesity, and family history.
Exclusion criteria
Exclusion criteria: (1) Imaging examinations (CCTA or CAG) reveal smooth coronary artery walls without thickening, calcification, luminal stenosis or dilation, and no evidence of atherosclerotic plaques.(2) No definite risk factors for coronary atherosclerosis, and no suspected myocardial ischemia symptoms such as chest pain or chest tightness.(3) Complicated with malignant tumors or autoimmune diseases (e.g., inflammatory bowel disease, positive antiphospholipid antibodies, positive lupus anticoagulant, thrombophilia, Takayasu arteritis, etc.).(4) Being pregnant or lactating, having the intention of childbearing within 1 year, or being of childbearing age without effective contraceptive measures.(5) Abnormal liver function (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] exceeding 5.0 times the upper limit of normal) or abnormal renal function (serum creatinine exceeding 2 mg/dl).(6) Suffering from severe chronic obstructive pulmonary disease (COPD) or respiratory failure; having a history of gastrointestinal, respiratory, or other organ bleeding, severe infection within the past month; or being in a state of severe debilitation such as cachexia.(7) Expected survival time of less than 1 year.(8) Hypersensitivity to the components of the study drug, or concurrent participation in other clinical studies.(9) TCM syndrome differentiation inconsistent with blood stasis syndrome, or planned use of similar traditional Chinese medicines (including proprietary Chinese medicines and decoctions) after enrollment.(10) Having received treatment with antacids, probiotics, antibiotics, immunosuppressants, glucocorticoids, or antimicrobials within 30 days prior to sample collection.(11) Other circumstances deemed inappropriate for participation in the study by the investigators (e.g., severe mental illness, inability to cooperate with follow-up, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood lipids; | — |
Secondary
| Measure | Time frame |
|---|---|
| inflammatory markers; blood glucose; | — |
Countries
China
Contacts
Public ContactLi Yujin
The first people's hospital of Yunnan Province
Outcome results
None listed