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Clinical Trial Protocol for the Study on the Clinical Efficacy of Buyang Huanwu Decoction in Improving Post-Stroke Cognitive Impairment

Study on the Clinical Efficacy of Buyang Huanwu Decoction in Improving Post-Stroke Cognitive Impairment

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025001905
Enrollment
Unknown
Registered
2025-10-15
Start date
2025-07-14
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Stroke Cognitive Impairment

Interventions

Control Group:None
Buyang Huanwu Decoction (as an alternative to tea) Intervention Group:Buyang Huanwu Decoction (as an alternative to tea)

Sponsors

Zhuhai Hospital of Integrated Traditional Chinese & Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 85 Years

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

MeasureTime frame
Minimum Mental State Examination;Montreal Cognitive Assessment;

Secondary

MeasureTime frame
Clinical Dementia Rating;

Countries

China

Contacts

Public ContactLi HUA

Zhuhai Hospital of Integrated Traditional Chinese & Western Medicine

rainlihua12@126.com13824128762

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026