HypertensionSXC-CSVDNCT07271732
Songling Xuemaikang Capsules for Cerebral Small Vessel Disease
A study testing Songling Xuemaikang Capsule in people with Hypertension and Cerebral Small Vessel Diseases, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial summary
Cerebral small vessel disease (CSVD) is a common age-related microvascular disease related to the slow accumulation of damage to small arteries, veins, and capillaries. Hypertension is a risk factor for cerebrovascular disease, and its damage to the vascular endothelium is one of the key contributing factors to the… Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Hypertension, Cerebral Small Vessel Diseases
- What is being tested?
- Songling Xuemaikang Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- 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.);
- 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;
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- 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);
- Severe three-vessel coronary artery disease as shown by coronary computed tomography angiography or coronary angiography within 90 days or suffering from frequent angina;
- Refractory hyperglycemia uncontrolled by medication (fasting blood glucose >10 mmol/L, or HbA1c >8.0%);
- 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;
- Previous allergy or intolerance to Songling Xuemaikang Capsules;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100700
Xinxing Lai, PhD, +86-15901111280, new-star@163.com
Yupeng WEI, +86-15313972930, ccwyp2010@163.com
About this study
Official title: Songling Xuemaikang Capsules for Cerebral Small Vessel Disease: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study
Cerebral small vessel disease (CSVD) is a common age-related microvascular disease related to the slow accumulation of damage to small arteries, veins, and capillaries. Hypertension is a risk factor for cerebrovascular disease, and its damage to the vascular endothelium is one of the key contributing factors to the pathogenesis of CSVD. CSVD has an insidious onset, and patients may exhibit no clinical symptoms in the early stage. Common clinical manifestations of chronic CSVD include vascular dementia, depression, gait disturbance, and abnormalities in swallowing and urinary functions. There is currently no specific treatment for CSVD.
Existing studies have shown that Songling Xuemaikang capsule (SXC) combined with antihypertensive drugs exerted significant effects on systolic blood pressure (SBP), diastolic blood pressure (DBP), 24-hour SBP, and 24-hour DBP, while also improving symptoms of hypertension. Animal experiments have demonstrated that SXC can reduce apoptosis and alleviate cerebral ischemia-reperfusion injury, exerting neuroprotective effects. Additionally, a previously completed multicenter, randomized, double-blind, non-inferiority-designed clinical trial by the team, conducted in patients with primary hypertension, showed that SXC were non-inferior to losartan potassium in reducing diastolic blood pressure. Therefore, exploring the therapeutic potential of SXC in CSVD is highly necessary.
This project is a randomized, double-blind, placebo-controlled multicenter clinical study to investigate the clinical efficacy and safety of SXC in the treatment of hypertension with CSVD. A total of 90 subjects who met the subject screening criteria are planned to be enrolled, with 45 patients in the test group and 45 patients in the placebo group.
- Conditions
- Hypertension, Cerebral Small Vessel Diseases
- Being tested
- Songling Xuemaikang Capsule, Songling Xuemaikang Capsule Placebo
- Medical subject headings
- Hypertension, Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Songling Xuemaikang CapsuleDrug
3 capsules/time, tid, p.o Duration of Treatment: 1 year (12 months)
Songling Xuemaikang Capsule PlaceboDrug
3 capsules/time, tid, p.o Duration of Treatment: 1 year (12 months)
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Songling Xuemaikang Capsule, 3 capsules/time, tid, p.o Receives: Drug: Songling Xuemaikang Capsule |
| Control group | Placebo comparator | Songling Xuemaikang Capsule placebo, 3 capsules/time, tid, p.o Receives: Drug: Songling Xuemaikang Capsule Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the volume of white matter hyperintensities at 1 year.
Measure changes in the volume of white matter hyperintensities on brain MRI
Measured: 1 year
Secondary outcomes (19)
Change from baseline in Mini-Mental State Examination (MMSE) at 1 year;
Change from baseline in Mini-Mental State Examination (MMSE). Score range is 0-30. Higher score means good cognition.
Measured: 1 year
Change from baseline in Hamilton Anxiety Scale (HAMA) at 1 year;
Change from baseline in Hamilton Anxiety Scale (HAMA).Score range is 0-56. Higher score means a more severe state of anxiety.
Measured: 1 year
Change from baseline in Hamilton Depression Scale (HAMD) at 1 year;
Change from baseline in Hamilton Depression Scale (HAMD). Score range is 0-76. Higher score means a more severe state of anxiety.
Measured: 1 year
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) at 1 year;
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) at 1 year. Score range is 0-21. Higher score means worse sleep quality.
Measured: 1 year
Change from baseline in Barthel Index (BI) at 1 year;
Change from baseline in Barthel Index (BI). Score range is 0-100. Higher score means good physical activities of daily living.
Measured: 1 year
Feasibility of recruitment and retention
The feasibility is defined as >95% of randomized patients retained at 1 year
Measured: 1 year
Change from baseline in the symptom of hyperactivity of liver yang pattern at 1 year;
Change from baseline in the symptom of hyperactivity of liver yang pattern, which are headache, dizziness or vertigo, irritability, flushed face, red eyes, and yellow tongue coating. The study plans to analyze whether there are statistically significant differences in the incidence of the above six symptoms before and after treatment. On the other hand, for headache, dizziness or vertigo, irritability, if they do not resolve at follow-up time points, patient-reported outcomes (PROs) will be used to record the degree of change in patients' symptoms from baseline (expressed as a percentage, with >100% indicating symptom worsening and <100% indicating symptom relief), and statistical analysis will be carried out. For flushed face, red eyes, and yellow tongue coating, binary analysis will be performed based solely on their presence or absence.
Measured: 1 year
Change from baseline in the mean 24h systolic blood pressure at 1 year;
Change from baseline in the mean 24h systolic blood pressure
Measured: 1 year
Change from baseline in the mean 24h diastolic blood pressure at 1 year;
Change from baseline in the mean 24h diastolic blood pressure
Measured: 1 year
Change from baseline in the mean daytime systolic blood pressure at 1 year;
Change from baseline in the mean daytime systolic blood pressure
Measured: 1 year
Change from baseline in the mean daytime diastolic blood pressure at 1 year;
Change from baseline in the mean daytime diastolic blood pressure
Measured: 1 year
Change from baseline in the mean nighttime systolic blood pressure at 1 year
Change from baseline in the mean nighttime systolic blood pressure
Measured: 1 year
Change from baseline in the mean nighttime diastolic blood pressure at 1 year
Change from baseline in the mean nighttime diastolic blood pressure
Measured: 1 year
Change from baseline in the mean 24h pulse pressure at 1year
Change from baseline in the mean 24h pulse pressure
Measured: 1 year
Change from baseline in the blood pressure load at 1 year
Change from baseline in the blood pressure load
Measured: 1 year
Change from baseline in the official systolic blood pressure at 1 year
Change from baseline in the official systolic blood pressure
Measured: 1 year
Change from baseline in the official diastolic blood pressure at 1 year
Change from baseline in the official diastolic blood pressure
Measured: 1 year
Change from baseline in the official pulse pressure at 1year
Change from baseline in the official pulse pressure
Measured: 1 year
Change from baseline in the official blood pressure compliance rate at 1 year
Change from baseline in the official blood pressure compliance rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start10 Dec 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Gao, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271732
- Sponsor's protocol ID
- 2025DZMEC-188-02
- Acronym
- SXC-CSVD
- Status last verified
- Dec 2025
- First submitted
- 27 Sep 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Songling Xuemaikang Capsules for Cerebral Small Vessel Disease: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT07271732
- Acronym / sponsor ID
- SXC-CSVD / 2025DZMEC-188-02
- Conditions
- Hypertension, Cerebral Small Vessel Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cerebral small vessel disease (CSVD) is a common age-related microvascular disease related to the slow accumulation of damage to small arteries, veins, and capillaries. Hypertension is a risk factor for cerebrovascular disease, and its damage to the vascular endothelium is one of the key contributing factors to the pathogenesis of CSVD. CSVD has an insidious onset, and patients may exhibit no clinical symptoms in the early stage. Common clinical manifestations of chronic CSVD include vascular dementia, depression, gait disturbance, and abnormalities in swallowing and urinary functions. There is currently no specific treatment for CSVD.
Existing studies have shown that Songling Xuemaikang capsule (SXC) combined with antihypertensive drugs exerted significant effects on systolic blood pressure (SBP), diastolic blood pressure (DBP), 24-hour SBP, and 24-hour DBP, while also improving symptoms of hypertension. Animal experiments have demonstrated that SXC can reduce apoptosis and alleviate cerebral ischemia-reperfusion injury, exerting neuroprotective effects. Additionally, a previously completed multicenter, randomized, double-blind, non-inferiority-designed clinical trial by the team, conducted in patients with primary hypertension, showed that SXC were non-inferior to losartan potassium in reducing diastolic blood pressure. Therefore, exploring the therapeutic potential of SXC in CSVD is highly necessary.
This project is a randomized, double-blind, placebo-controlled multicenter clinical study to investigate the clinical efficacy and safety of SXC in the treatment of hypertension with CSVD. A total of 90 subjects who met the subject screening criteria are planned to be enrolled, with 45 patients in the test group and 45 patients in the placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: Songling Xuemaikang CapsuleSongling Xuemaikang Capsule, 3 capsules/time, tid, p.o |
| Control group | Placebo comparator | Drug: Songling Xuemaikang Capsule PlaceboSongling Xuemaikang Capsule placebo, 3 capsules/time, tid, p.o |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (15 listed)
- 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;
- 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.);
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Songling Xuemaikang Capsule3 capsules/time, tid, p.o Duration of Treatment: 1 year (12 months) | Drug | Test group |
| Songling Xuemaikang Capsule Placebo3 capsules/time, tid, p.o Duration of Treatment: 1 year (12 months) | Drug | Control group |
Primary outcome
Changes in the volume of white matter hyperintensities at 1 year.
Time frame: 1 year
Measure changes in the volume of white matter hyperintensities on brain MRI
19 secondary outcomes
Change from baseline in Mini-Mental State Examination (MMSE) at 1 year;
Time frame: 1 year
Change from baseline in Hamilton Anxiety Scale (HAMA) at 1 year;
Time frame: 1 year
Change from baseline in Hamilton Depression Scale (HAMD) at 1 year;
Time frame: 1 year
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) at 1 year;
Time frame: 1 year
Change from baseline in Barthel Index (BI) at 1 year;
Time frame: 1 year
Feasibility of recruitment and retention
Time frame: 1 year
Change from baseline in the symptom of hyperactivity of liver yang pattern at 1 year;
Time frame: 1 year
Change from baseline in the mean 24h systolic blood pressure at 1 year;
Time frame: 1 year
Change from baseline in the mean 24h diastolic blood pressure at 1 year;
Time frame: 1 year
Change from baseline in the mean daytime systolic blood pressure at 1 year;
Time frame: 1 year
Change from baseline in the mean daytime diastolic blood pressure at 1 year;
Time frame: 1 year
Change from baseline in the mean nighttime systolic blood pressure at 1 year
Time frame: 1 year
Change from baseline in the mean nighttime diastolic blood pressure at 1 year
Time frame: 1 year
Change from baseline in the mean 24h pulse pressure at 1year
Time frame: 1 year
Change from baseline in the blood pressure load at 1 year
Time frame: 1 year
Change from baseline in the official systolic blood pressure at 1 year
Time frame: 1 year
Change from baseline in the official diastolic blood pressure at 1 year
Time frame: 1 year
Change from baseline in the official pulse pressure at 1year
Time frame: 1 year
Change from baseline in the official blood pressure compliance rate at 1 year
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Songling Xuemaikang Capsule in people with Hypertension and Cerebral Small Vessel Diseases, run by Dongzhimen Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinxing Lai, PhD (+86-15901111280, new-star@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the volume of white matter hyperintensities at 1 year. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.