A Clinical Trail of Integrative Medicine Approaches for Post-Stroke Cognitive Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-25

Study Completion Date

2024-12-31

Brief Summary

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The traditional Chinese medicine rehabilitation for the post-stroke cognitive impairment will be intervened, which can promote the recovery of post-stroke cognitive function patients, reduce the disability rate and improve the quality of life.

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Detailed Description

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This study will collect inpatients from April 2019 to December 2024 who from the third affiliated hospital of Zhejiang university of traditional Chinese medicine, Jiaxing hospital of traditional Chinese medicine, Hangzhou hospital of traditional Chinese medicine.this study sets strict time window (stroke recovery, 30-180 days), use multi-center, large sample, randomized controlled study method and the objective recognition rehabilitation evaluation criteria and efficacy evaluation system to evaluate the clinical effect and analysis of health economics.

Conditions

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Post-stroke Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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control

standard treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

treatment

standard treatment, regular cognitive function training, acupuncture, and herbs

Group Type EXPERIMENTAL

Chinese traditional rehabilitation

Intervention Type COMBINATION_PRODUCT

Chinese traditional rehabilitation including acupuncture and herbs

Interventions

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Chinese traditional rehabilitation

Chinese traditional rehabilitation including acupuncture and herbs

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

1. Stroke as per the TCM definition, presenting symptoms include unilateral paresis or paralysis, sensory deficits, speech impairment, and hemianopsia. PSCI diagnosis involves clinically significant deficits in at least one cognitive domain and severe disruption of instrumental activity of daily livings.
2. age above 18 years;
3. disease duration of 30-180 days;
4. written informed consent by the patient's legal guardian;
5. MoCA (Montreal Cognitive Assessment) score of 17-26. If patient was educated for ≤ 12 years, one score will be deducted;
6. HAMD(Hamilton Depression Scale) score \< 20;
7. indications for acupuncture and moxibustion techniques.

Exclusion Criteria

1. Cognitive impairment caused by subarachnoid hemorrhage, transient ischemic attack, or other intracranial lesions., such as tumors, aneurysms, vascular malformations, cysticercosis, schistosomiasis, encephalitis, meningitis, hydrocephalus, or head trauma;
2. non-atherosclerotic thrombotic cerebral infarction (such as cardiac embolism, procoagulant state, endovascular shedding, or arteritis);
3. pregnant or lactating women;
4. severe chronic diseases of the heart, liver, kidneys, other viscera, or endocrine system or hematopoietic system;
5. severe dementia, serious language understanding disorders, or mental illness;
6. bleeding tendency;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No