Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT07271732
Eligibility Criteria:
Inclusion Criteria:
1. Age 55-75 years (both inclusive);
2. 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;
3. 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.
4. 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.
5. Functional independence in daily living (Modified Rankin Scale ≤2);
6. Voluntary participation in the study and be willing to sign the Informed Consent Form.
Exclusion Criteria:
1. 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;
2. 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%);
3. Untreated cerebrovascular malformations or intracranial aneurysms (diameter \>3 mm);
4. Significant non-vascular white matter lesions (e.g., multiple sclerosis, adult-onset leukoencephalopathy, metabolic encephalopathy, etc.);
5. 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.);
6. A history of intracranial or intramedullary surgery within the past year;
7. 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);
8. Severe three-vessel coronary artery disease as shown by coronary computed tomography angiography or coronary angiography within 90 days or suffering from frequent angina;
9. Refractory hyperglycemia uncontrolled by medication (fasting blood glucose \>10 mmol/L, or HbA1c \>8.0%);
10. Patients with severe diseases such as cancer and a life expectancy of less than 2 years;
11. Patients with psychiatric disorders that affect study medication administration and evaluation;
12. Previous allergy or intolerance to Songling Xuemaikang Capsules;
13. Contraindications to MRI examination (e.g., claustrophobia, presence of an implantable pacemaker, etc.);
14. Patients unable to comply with follow-up examinations or other study procedures due to residential location or other reasons;
15. Participation in other clinical trial projects.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
75 Years
Study:
NCT07271732
Study Brief:
Protocol Section:
NCT07271732