Carotid atherosclerosis
Conditions
Interventions
Experimental Group:Yin Dan Xinnao Tong Soft Capsules (Ingredients: Ginkgo biloba leaf, Salvia miltiorrhiza, Chrysanthemum indicum, Gynostemma pentaphyllum, Hawthorn, Garlic, Notoginseng, Mugwort leaf)
Control Group:Silver Dan Xinnao Tong soft capsule placebo (ingredients: 5% Silver Dan Xinnao Tong soft capsule drug, dextrin), oral, 4 capsules per dose, 3 times daily, taken after meals with warm wat
Sponsors
Beijing University of Chinese Medicine Dongzhimen Hospital Medical
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Confirmed carotid atherosclerotic plaque formation by color Doppler ultrasound; 2) (Meets the diagnostic criteria for blood stasis syndrome in Traditional Chinese Medicine); 3) Age between 40 and 80 years, gender (unrestricted); 4) Lumen stenosis <70%; 5) Able to adhere to long-term medication; 6) Patient provides informed consent and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients in the acute phase of cerebrocardiovascular diseases; 2) Individuals with a history of intracranial hemorrhage; 3) Those contraindicated for MRI and contrast agents (e.g., those with pacemakers, dental amalgam, stents, etc.); 4) Patients with active ulcers or a tendency to bleed, and long-term users of anticoagulant medications (e.g., warfarin); 5) Patients with severe arrhythmias, atrial fibrillation, or heart failure; 6) Individuals with severe primary diseases of the liver, kidneys, hematopoietic system, endocrine system, or respiratory system, with liver function exceeding 1.5 times the upper limit of normal or elevated creatinine (Cr) levels; 7) Pregnant or breastfeeding women, or women with plans for pregnancy in the near future; 8) Individuals with a history of allergies; 9) Those currently taking lipid-regulating medications (including both Western and traditional Chinese medicine) or who have discontinued such medications for less than 2 weeks; 10) Those currently using dual antiplatelet medications or who have discontinued such medications for less than 2 weeks; 11) Any other life-threatening or severe conditions that would prevent completion of a 3-month treatment and thereby affect evaluation results; 12) Other diseases or mental illnesses that the investigator believes may limit the assessment of efficacy or patient follow-up; 13) Patients who have participated in other drug clinical trials within the past 4 weeks; 14) Patients meeting the criteria for interventional treatment of carotid atherosclerotic plaques.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total volume of carotid plaque (in mm³) and percentage.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Carotid Plaque Report and Data System (Plaque-RADS) Rating;The volume and percentage of the lipid necrotic core in the plaque.;Fibrous Cap Status;Fibrous cap volume and percentage;Minimum Fibrillar Cap Thickness;Intraplaque hemorrhage volume and percentage;Calcification Pattern;Calcification Volume and Percentage;Maximum pipe wall thickness;Average Pipe Wall Thickness;Lumen stenosis rate;Standardized Vascular Wall Index;Pipe Wall Volume;Total Load on Pipe Wall;Plaque Thickness Reduction Value and Percentage (Transverse Section Measurement);The reduction value and percentage of plaque area (longitudinal section);intima-media thickness;Carotid Atherosclerosis Score;Weight;blood pressure;blood lipids;Blood Glucose;Traditional Chinese Medicine symptoms and syndromes;Blood Proteomics; | — |
Countries
China
Contacts
Public ContactWu Shengxian
Beijing University of Chinese Medicine Dongzhimen Hospital
Outcome results
None listed