mild to moderate carotid stenosis
Conditions
Interventions
Controled group:Lifestyle adjustment (diet, exercise and/or other systemic drugs)
Experimental group:Lifestyle adjustment (diet, exercise and/or other systemic drugs) + Maiguan Fukang tablets 4 tablets /time, 3 times /day
Sponsors
Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Meet with western medical diagnostic criteria for mild to moderate carotid artery stenosis (stenosis rate <50%, confirmed by cerebral angiography or CTA or MRA or non-invasive examination, refer to the guidelines for the diagnosis and treatment of carotid stenosis and the guidelines for vascular ultrasonography in stroke in China); (2) Meet the diagnostic criteria of blood stasis syndrome in traditional Chinese medicine (refer to the "Practical Diagnostic Criteria of Blood Stasis Syndrome" by the Chinese Society of Integrative Medicine); (3) Ultrasonography revealed that the carotid artery intima-media is thickened (IMT=1.2mm), and the carotid artery plaques are iso-echoic plaques or mixed-echo plaques; (4) The 10-year cardiovascular disease risk is less than 5%; (5) Adult patients are aged 18-70 (no gender limit, including 18-year-old and 70-year-old patients); (6) Informed and signed informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with intracranial hemorrhage, subarachnoid hemorrhage in the past 3 months, or fresh cerebral infarction or transient ischemic attack in the past 1 month; (2) Cardiogenic embolism (atrial fibrillation, patent foramen ovale, left atrial appendage thrombosis, etc.); (3) Carotid artery stent (CAS) or carotid artery stent (CEA) surgery is planned; (4) The plaque is complete calcification, or the ultrasound examination indicates a hyperechoic plaque or an ulcer plaque; (5) Patients with active bleeding or high risk of bleeding (such as those with peptic ulcer, bronchiectasis, and tuberculosis in the last 3 months); (6) Patients with severe heart, brain, liver, kidney, hematopoietic system, connective tissue diseases, endocrine diseases and mental diseases (such as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >1.5 times the upper limit of normal value and serum creatinine (SCR) > the upper limit of normal value; or patients with low density lipoprotein(LDL-C)=3.4mmol/L; (7) Allergic to the test drug and its components, or allergic constitution; (8) Those who have planned to perform surgery within the experimental period or within 10 days after the end of the experiment; (9) Hypertensive patients with blood pressure >180/110mmHg that cannot be controlled through the best treatment plan; (10) Patients with coronary heart disease: coronary artery stenosis = 75% confirmed by coronary angiography or coronary CT angiography, or after percutaneous coronary intervention (PCI), or old myocardial infarction; (11) Pregnant, planned or lactating women; (12) Those who have participated or are participating in other clinical research within 3 months; (13) Those who judged by the investigator to be unsuitable to participate in this trial or are likely to be lost to follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean IMT of common carotid artery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean IMT of extracranial internal carotid artery;resistance index of carotid artery;End-diastolic flow rate of carotid artery;Carotid artery stenosis rate;Mean IMT of carotid bulb;peak systolic velocity of carotid artery;Carotid plaque area;Carotid plaque size;Blood lipids;Total score of bilateral carotid plaque ;TCM Syndrome Score of Blood Stasis Syndrome;Maximum IMT of common carotid artery;hs-CRP;Seattle Angina Questionnaire;Maximum IMT of carotid bulb;Maximum IMT of extracranial internal carotid artery; | — |
Countries
China
Contacts
Public ContactChanggeng Fu
Outcome results
None listed