Cerebral small vessel disease
Conditions
Interventions
Intervention Group:Kidney-tonifying and intellect-enhancing formula
Control Group:Placebo
Sponsors
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for cognitive impairment due to small vessel disease of the brain; (2) Meets the diagnostic criteria for deficiency of kidney yang with stasis in the meridians; (3) Hachinski ischemia score =7 points; (4) 16 = Montreal Cognitive Assessment (MoCA) =26; (5) Clinical Dementia Rating (CDR) =2 points; (6) Aged 40-85 years, gender unrestricted; (7) Able to cooperate with trial examinations; (8) The volunteer subject and their guardian have signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those with a confirmed diagnosis or suspected to have other types of dementia based on existing medical history, scales, imaging examinations, etc., such as Alzheimer's disease, Lewy body dementia, frontotemporal dementia, Parkinson's disease, mixed dementia, demyelinating diseases of the central nervous system, tumors, hydrocephalus, trauma, or central nervous system infections; (2) Those with severe neurological deficits unable to complete examinations, such as hemiplegia, various types of aphasia, or sensory impairments; (3) Those who have been confirmed within the past 6 months to be dependent on alcohol or drugs; (4) Those with a confirmed diagnosis of depression, i.e., a Hamilton Depression Rating Scale (HAMD) score =17; (5) Those with severe primary diseases, such as severe heart failure, liver or kidney dysfunction, or active pathological bleeding (e.g., peptic ulcer bleeding, active hematuria, coagulation disorders, or severe thrombocytopenia); (6) Those with a history of allergies or allergies to the investigational drug; (7) Those currently using drugs that improve cognition or have similar effects to the study drug, such as acetylcholinesterase inhibitors; (8) Those unable to undergo cranial magnetic resonance imaging (MRI).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Montreal Cognitive Assessment scores compared to baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| MMSE Score;VaDAS-Cog Score;ADL score;CDR-SB Scale;TMT Rating;CDT Rating;NPI Scoring;TCM syndrome score; | — |
Countries
China
Contacts
Public ContactXu Zhenmin
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Outcome results
None listed