Carotid atherosclerosis
Conditions
Interventions
Treatment group:Oral Guanxinning Tablets at a dose of 6 tablets twice daily, in addition to standard treatment
Control group:Standard treatment
Sponsors
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Voluntary participation, with understanding and signing of the informed consent form; (2) Age =18 years and =75 years, regardless of gender; (3) Meeting the diagnostic criteria: carotid intima-media thickness (cIMT) =1.5 mm, protruding into the vascular lumen or localized thickening, and exceeding 50% of the surrounding cIMT; (4) Syndrome differentiation conforming to the traditional Chinese medicine pattern of "heart blood stasis syndrome"
Exclusion criteria
Exclusion criteria: (1) Patients with carotid atherosclerotic plaque causing stenosis = 70%; (2) History of carotid endarterectomy; (3) Poorly controlled hypertension, defined as resting systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 110 mmHg on two independent measurements prior to randomization; (4) Within the past 3 months: acute coronary syndrome, stroke, transient ischemic attack; cardiac, carotid, or other major vascular surgery; percutaneous coronary intervention, carotid angioplasty, coronary artery bypass grafting, or other cardiac surgery; (5) Major surgery within 6 months prior to randomization; (6) Hemoglobin concentration = 9 g/dL and/or presence of hematological disorders; (7) Complicated with heart failure and severe arrhythmias (persistent rapid atrial fibrillation, atrial flutter, frequent premature ventricular contractions, ventricular tachycardia, second-degree or higher atrioventricular block), or concomitant severe primary diseases of the liver, kidney, hematopoietic system, nervous system, or endocrine system; patients with malignancy or psychiatric disorders; (8) Life expectancy less than 1 year; (9) Participation in another clinical drug trial within the past 1 month; (10) Known allergy to the investigational drug (including its components); (11) Patients currently taking Chinese herbal medicines or proprietary Chinese medicines with compositions similar to Guanxinning Tablets or that have the effect of resolving phlegm-turbidity; (12) Pregnancy (positive pregnancy test) or lactation; women of childbearing age (15–49 years) who fail to adhere to strict contraceptive measures during the study period; (13) In the opinion of the investigator, patients who are unable to complete the study or comply with study requirements (due to administrative reasons or other factors)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Carotid intima-media thickness; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood lipids;Body fat percentage;Segmental fat analysis;Visceral fat grade;Cardiovascular and cerebrovascular events; | — |
Countries
China
Contacts
Public ContactLijing Zhang
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Outcome results
None listed