Stabilizing carotid atherosclerotic plaque
Conditions
Interventions
Control group:Tongsai Mai tablet placebo oral 5 tablets/time 3 times/day after meals with warm water to take.
Experimental group:Tongsai Mai tablet oral 5 tablets/time 3 times/day after meals with warm water to take.
Sponsors
Dongzhimen Hospital Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Patients with a history of ischemic stroke and carotid atherosclerotic plaque formation confirmed by color Doppler ultrasound; 2) Echoless/hypoechoic/mixed echoic plaques or plaque surface is not smooth/fiber cap is not complete/blood flow is not full; 3) Age between 40 and 80 years old regardless of gender; 4) can adhere to long-term medication; 5) No recent use of anti-inflammatory drugs; 6) The patient gives informed consent and signs the informed consent.
Exclusion criteria
Exclusion criteria: 1) Acute or subacute hemorrhage within the plaque; 2) Complete calcification and fibrosis of plaque; 3) MRI and contrast media contraindications (such as carrying pacemakers dentures stents etc.); 4) Active ulcer and bleeding tendency long-term use of anticoagulant drugs (such as warfarin); 5) Patients with severe arrhythmia atrial fibrillation and heart failure; 6) Have serious liver kidney hematopoietic system endocrine system respiratory system and other primary diseases liver function is more than 1.5 times higher than the upper limit of normal Cr is higher than the normal value; 7) Any other life-threatening or serious illness that cannot be completed within 6 months of treatment so as to affect the evaluation results; 8) Pregnant or lactating women women with a recent pregnancy plan; 9) People with allergies; 10) Other diseases or mental disorders that the investigator believes may limit evaluation of efficacy or patient follow-up; 11) Patients who have participated in clinical trials of other drugs within the last 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cerebrovascular event incidence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Biomarker indices for plaque vulnerability assessment.;Interleukin-6(IL-6);blood pressure;Blood Sugar;Interleukin-1ß(IL-1ß);tumor necrosis factor-alpha?(TNF-a?);Weight;Blood lipid;hypersensitive C-reactive protein(hs-CRP); | — |
Countries
China
Contacts
Public ContactWu Shengxian
Dongzhimen Hospital Beijing University of Chinese Medicine
Outcome results
None listed