Herbal capsule may slow brain vessel damage in hypertensive patients
NCT ID NCT07271732
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether Songling Xuemaikang capsules can help control cerebral small vessel disease (CSVD), a condition where small blood vessels in the brain get damaged over time, often linked to high blood pressure. Researchers will enroll 90 adults aged 55-75 with hypertension and signs of CSVD on MRI. Half will get the herbal capsule, half a placebo, and all will continue their usual blood pressure medications. The main goal is to see if the capsule reduces brain white matter damage after one year.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100700, China
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