Post-Stroke Cognitive Impairment
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Conform to the diagnostic criteria for acute ischemic stroke, and in terms of syndrome differentiation in Traditional Chinese Medicine (TCM), belong to the syndrome of qi and blood deficiency, the syndrome of qi and blood deficiency complicated with marrow sea insufficiency, or the syndrome of qi and blood deficiency complicated with spleen-kidney deficiency; (2) For neuropsychological assessments, the scores meet the following criteria: the Mini-Mental State Examination (MMSE) score is between 6 and 17 (exclusive of the boundary values) for illiterate patients, between 8 and 20 (exclusive of the boundary values) for patients with primary school education, and between 10 and 24 (exclusive of the boundary values) for patients with junior high school education or above; the Montreal Cognitive Assessment (MoCA) score is between 12 and 26 (exclusive of the boundary values); and the Clinical Dementia Rating (CDR) score is = 2; (3) Aged 45–85 years, has signed the informed consent form, and is willing to participate in the study and accept relevant assessments; (4) Has obtained the patient's informed consent and signed the informed consent form; (5) Has a correct understanding of the significance of the drug study and good compliance with the observations and evaluations conducted by the researchers; (6) Has a certain level of reading ability, and was able to read simple newspaper articles and write simple sentences in the past; (7) Has clear consciousness and sufficient visual and auditory discrimination ability to undergo neuropsychological tests.
Exclusion criteria
Exclusion criteria: (1) Belong to the types of syndrome of blood stasis blocking cerebral collaterals or syndrome of phlegm turbidity clouding the orifices in TCM syndrome differentiation; (2) Cranial susceptibility-weighted imaging (SWI) indicates multiple cerebral microbleeds or abnormal distribution; (3) Patients with cognitive impairment present before recurrent stroke; (4) Clinical Dementia Rating (CDR) assessed as severe dementia (CDR = 3.0); (5) Patients with obvious mental and emotional disorders, such as depression, schizophrenia, schizoaffective disorder, including those with a previous history of adult affective disorder; (6) Patients with acute alcohol intoxication that may interfere with the evaluation of cognitive function, or a history of alcohol intoxication or psychotropic drug abuse; (7) Patients with neurological diseases that can cause cognitive impairment, such as traumatic brain injury, epilepsy, encephalitis, and normal pressure hydrocephalus; (8) Patients with other diseases that can cause cognitive impairment, such as malignant tumors, thyroid dysfunction, syphilis, as well as patients with severe anemia and glaucoma; (9) Patients with severe primary diseases involving the heart, liver, kidneys, hematological system, or other such systems; (10) Patients with severe dyspepsia, gastrointestinal obstruction, gastric or duodenal ulcers, as well as those with other gastrointestinal diseases that may affect drug absorption; (11) Patients who have had allergic reactions to this drug, or those participating in other research studies; (12) Patients with severe neurological deficits that prevent them from completing relevant examinations, such as hemiplegia of the dominant hand, various types of aphasia, and visual or auditory impairments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimum Mental State Examination;Montreal Cognitive Assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Dementia Rating; | — |
Countries
China
Contacts
Zhuhai Hospital of Integrated Traditional Chinese & Western Medicine