Cerebral small vessel disease
Conditions
Interventions
Control group:Standardized medical treatments such as blood pressure lowering, lipid regulation, and antiplatelet therapy.
Observation group:Based on the standardized medical treatments recommended in the guidelines, such as antihypertensive, lipid-lowering, and antiplatelet therapies, clinicians may autonomously decide t
Sponsors
Hunan Provincial Hospital of Integrated Traditional and Western Medicine (Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: (1) Age = 18 years; (2) Presence of physical disabilities; (3) Meets the diagnostic criteria for CSVD (Cerebral Small Vessel Disease); (4) Meets the diagnostic criteria for Qi deficiency and blood stasis syndrome in Traditional Chinese Medicine; (5) The patient or their legal representative voluntarily participates in the study and signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Combine Alzheimer's disease, frontotemporal dementia, Lewy body dementia, Parkinson's disease, multiple sclerosis, traumatic brain injury, and other neurological diseases leading to cognitive impairment; (2) Severe cardiovascular and cerebrovascular diseases such as myocardial infarction, heart failure, severe arrhythmias, and intracerebral hemorrhage, or those with large vessel lesions in the brain; (3) Severe diseases of the liver, kidneys, digestive system, or hematopoietic system; (4) Patients with moderate to severe dementia or depression, or other psychiatric disorders; (5) Pregnant women, those planning pregnancy within the next six months, or breastfeeding women; (6) Individuals with suspected or confirmed history of alcohol or substance abuse; (7) Individuals with a history of allergies; (8) Those with a potential risk of dropping out of the study, such as frequent changes in work environment or unstable living conditions that may lead to loss of follow-up; (9) Patients who have participated in or are currently participating in other clinical trials within the past three months; (10) Other diseases causing cerebral small vessel disease (CSVD).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Simplified Fugl-Meyer Motor Assessment (FMA); | — |
Secondary
| Measure | Time frame |
|---|---|
| Hopkins Verbal Learning Test (HVLT);Trail Making Test (TMT);Clock Drawing Test (CDT);Boston Naming Test (BNT);Modified Rankin Scale (mRS);Montreal Cognitive Assessment (MoCA);National Institutes of Health Stroke Scale (NISS);Hospital Anxiety and Depression Scale (HADS);Pain Visual Analog Scale (VAS);Metabolic-related indicators: clinic blood pressure, including LDL-C, HDL-C, and a full lipid profile.;The proportion of new-onset vascular events.; | — |
Countries
China
Contacts
Public ContactWu Dahua, Fang Rui
Hunan Provincial Hospital of Integrated Traditional and Western Medicine (Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine)
Outcome results
None listed