Post-stroke cognitive impairment
Conditions
Interventions
Experimental Group:Yisui Fuzhi Decoction + "Yisui Xingshen" Acupuncture Plan + Basic Treatment
Control Group:Yi Sui Recovery Agent + Yi Sui Awakening Acupuncture Protocol + Basic Treatment
Sponsors
Beijing University of Chinese Medicine Dongzhimen Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for post-stroke cognitive impairment (refer to "Expert Consensus on the Management of Post-stroke Cognitive Impairment, 2021") and Traditional Chinese Medicine (TCM) ischemic stroke ("Diagnostic and Efficacy Assessment Criteria for Stroke"), as well as the diagnostic criteria for the TCM syndrome elements of kidney deficiency ("Kidney Essence Deficiency Scale for Stroke"), phlegm turbidity (phlegm-dampness) ("Diagnostic Scale for Syndrome Elements of Ischemic Stroke"). 2. Age at onset: 30-80 years old. 3. Educational level: More than 5 years. 4. Montreal Cognitive Assessment (MOCA) score <26. 5. Mini-Mental State Examination (MMSE) score: 10 < MMSE <27. 6. Modified Rankin Scale (mRS) score =3. 7. Hamilton Depression Rating Scale (HIS) score =7. 8. The participant has given informed consent and voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of cognitive decline due to cerebral infarction or cognitive decline caused by other diseases; 2. Conditions that may affect neuropsychological assessment symptoms or performance, such as severe visual, auditory, or language impairments (NIHSS aphasia subscale score =2 points) or emotional disorders, uncontrolled active mental illnesses, etc., which prevent cooperation with scale assessments; 3. Participants who may affect follow-up, such as those with severe heart, lung, liver, or kidney dysfunction; 4. History of alcohol or drug abuse; 5. Pregnant or breastfeeding women; 6. Patients who received cognitive enhancers or other anti-dementia drug treatments within one month before the screening period or are currently taking medications that may affect cognitive function; 7. Unable to complete magnetic resonance imaging (MRI) examinations; 8. Allergy to known Chinese herbal medicine components; 9. Currently participating in other clinical trials; 10. Conditions that the investigator believes may jeopardize the safety of the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in Clinical Dementia Rating Scale (CDR-SB) scores after 12 weeks of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in scores of multidimensional neurological scales at baseline and at 12-week, 24-week, and 48-week post-enrollment.;Changes in multidimensional neurological scale scores at baseline and 12 weeks after enrollment.;Changes in multidimensional metrics based on the REB- system at baseline and 12-week post-enrollment.;Changes in neuroimaging biomarkers after enrollment and at 12 weeks.;Conversion rate to non-dementia at 12 weeks after treatment initiation (number of patients with CDR-SB =4.0 / total number of patients);Multi-omics indices; | — |
Countries
China
Contacts
Public ContactChang Jingling
Beijing University of Chinese Medicine Dongzhimen Hospital
Outcome results
None listed