Post-stroke cognitive impairment
Conditions
Interventions
Experimental Group:Peiyuan Tongnao Capsule + Guideline-based Treatment
Control Group:Peiyuan Tongnao Capsule Placebo + Guideline-based 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 diagnostic criteria for post-stroke cognitive impairment and Traditional Chinese Medicine (TCM) diagnosis of ischemic stroke, with kidney deficiency and blood stasis as pathogenic factors. 2. Age at onset: 30-80 years old. 3. Educational level: more than 5 years. 4. MOCA score <26. 5. MMSE score: 10 < MMSE <27. 6. mRS score =3. 7. HIS score =7. 8. Signed informed consent in accordance with ethical requirements.
Exclusion criteria
Exclusion criteria: 1. History of cognitive decline due to stroke or other diseases; 2. Conditions that may affect neuropsychological assessment symptoms or performance, such as severe visual, auditory, or language impairments (NIHSS aphasia subscore = 2 points), emotional disorders, or uncontrolled active psychiatric diseases, which prevent cooperation with scale assessments; 3. History of alcohol or substance abuse; 4. Severe heart, lung, liver, or kidney dysfunction, or unstable vital signs; 5. Pregnant or breastfeeding women; 6. Receipt of cognitive enhancers or other anti-dementia medications (e.g., cholinesterase inhibitors or non-competitive N-methyl-D-aspartate (NMDA) receptor antagonists) within the month prior to screening or current use of medications that may affect cognitive function; 7. Inability to complete magnetic resonance imaging (MRI) scans; 8. Allergy to known Chinese herbal components; 9. Currently participating in other clinical trials; 10. Any condition deemed by the investigator to potentially jeopardize the safety of the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) at 12 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Dementia Rating Scale;Trail Making Test;Multimodal MRI Analysis Data;Non-Dementia Conversion Rate;Auditory Verbal Learning Test;Mini-Mental State Examination;Montreal Cognitive Assessment Scale;Activities of Daily Living; | — |
Countries
China
Contacts
Public ContactChang Jingling
Beijing University of Chinese Medicine Dongzhimen Hospital
Outcome results
None listed