Songling Xuemaikang Capsules for Cerebral Small Vessel Disease

Prior treatment

• Previous allergy or intolerance to Songling Xuemaikang Capsules;

Other illness

• Patients with acute ischemic stroke or acute intracranial hemorrhage (e.g., epidural hematoma, subdural hematoma, subarachnoid hemorrhage, intracerebral hemorrhage, etc.) or a history of cerebral infarction (non-lacunar) or intracranial hemorrhage within the past 3 months;
• Patients with a history of cognitive impairment due to other causes (e.g., normal pressure hydrocephalus, Alzheimer's disease, Parkinson's disease, multiple sclerosis, encephalitis, etc.);
• A history of intracranial or intramedullary surgery within the past year;
• Severe three-vessel coronary artery disease as shown by coronary computed tomography angiography or coronary angiography within 90 days or suffering from frequent angina;
• Patients with severe diseases such as cancer and a life expectancy of less than 2 years;
• Patients with psychiatric disorders that affect study medication administration and evaluation;

Lab values

• Severe hepatic, renal, or cardiac insufficiency (ALT or AST \>2 times the upper limit of normal, or serum creatinine \>1.5 times the upper limit of normal, or New York Heart Association \[NYHA\] functional class III or IV);
• Refractory hyperglycemia uncontrolled by medication (fasting blood glucose \>10 mmol/L, or HbA1c \>8.0%);

Other

• Symptomatic stenosis of the middle cerebral artery and/or internal carotid artery (stenosis rate ≥50%), or asymptomatic stenosis of the middle cerebral artery and/or internal carotid artery (stenosis rate ≥70%);
• Untreated cerebrovascular malformations or intracranial aneurysms (diameter \>3 mm);
• Significant non-vascular white matter lesions (e.g., multiple sclerosis, adult-onset leukoencephalopathy, metabolic encephalopathy, etc.);
• Contraindications to MRI examination (e.g., claustrophobia, presence of an implantable pacemaker, etc.);
• Patients unable to comply with follow-up examinations or other study procedures due to residential location or other reasons;
• Participation in other clinical trial projects.

• Age 55-75 years (both inclusive);
• MRI has moderate to (1) severe white matter lesions (deep Fazekas score \> 1 or paraventricular Fazekas score \> 2 or modified Fazekas score \> 1), or (2) mild white matter hyperintensity (deep Fazekas score = 1 or paraventricular Fazekas score = 2 or modified Fazekas score = 1) combined with more than 1 lacunar infarction;
• History of essential hypertension; Hypertension is defined as SBP consistently greater than 140 mmHg and/or DBP consistently greater than 90 mmHg, or those requiring clinical antihypertensive treatment.
• Meeting the diagnostic criteria for hyperactivity of liver yang pattern; Hyperactivity of liver yang pattern is defined as having at least three of the following six symptoms: headache, dizziness or vertigo, irritability, flushed face, red eyes, and yellow tongue coating.
• Functional independence in daily living (Modified Rankin Scale ≤2);
• Voluntary participation in the study and be willing to sign the Informed Consent Form.