Cerebral small vessel disease
Conditions
Interventions
Intervention group:Yang Luo Di Tan Yi Sui Fang Granules
Placebo group:Yang Luo Di Tan Yi Sui Fang Simulator
Sponsors
Dongfang Hospital Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1 Meets the MRI diagnostic criteria for CSVD and stroke onset; 2 Ischemic stroke (clinical lacunar syndrome) onset = 21 days; 3 Age 40 = age = 75 years; 4 Neuropsychological assessment: MoCA score < 26 (education < 9 years plus 1) or 19 (17 for 0 years of education) = MMSE score = 26 (24 for 0 years of education) CDR score = 1 point; 5 Good audiovisual and language functions or the ability to complete neuropsychological tests after correction; 6 Participants or their authorized representatives sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1 Exclude cerebral infarction caused by atherosclerosis of large arteries cardiac embolism other causes or unknown causes according to the TOAST classification; 2 Concurrent cerebral hemorrhage of any type; 3 Allergy to any component of the investigational drug; 4 sporadic as well as hereditary cerebral amyloid angiopathy hereditary small vessel disease caused by nonamyloid vascular degeneration inflammatory as well as immune–mediated small vessel disease venous collagen disease or other small vessel diseases; 5 Cortical infarction or watershed infarction hemorrhage hydrocephalus or white matter lesions caused by other causes (such as multiple sclerosis carbon monoxide poisoning hypoxic encephalopathy hypoglycemia etc.); 6 Cognitive impairment diseases caused by other non-vascular factors such as degenerative diseases: e.g. Alzheimer's disease Parkinson's disease frontotemporal dementia Lewy body dementia etc.; 7 Other systemic diseases that can cause cognitive impairment such as thyroid dysfunction severe anemia folate and vitamin B12 deficiency liver dysfunction kidney dysfunction specific infections (such as syphilis HIV) alcohol and drug abuse etc.; 8 Hippocampal or entorhinal cortex atrophy [medial temporal lobe atrophy (MTA) score > 1 point]; 9 History of moderate to severe depression/anxiety psychosis or prolonged use of psychotropic medications; 10 Concurrent severe organic diseases of the heart lungs liver kidneys etc.; 11 Presence of contraindications for MRI; 12 Refusal to undergo blood draw.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vascular dementia assessment scale-cog; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale-17;Mini-Mental State Examination;Montreal Cognitive Assessment;multi-omics;Hamilton Anxiety Scale;Traditional Chinese Medicine Syndrome Score?;Mild Behavioral Impairment Checklist;Activity of Daily Living Scale; | — |
Countries
China
Contacts
Public ContactXianglan Jin
Dongfang Hospital Beijing University of Chinese Medicine
Outcome results
None listed