Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia
1 other identifier
interventional
40
1 country
1
Brief Summary
To observe the clinical efficacy of TCM acupuncture combined with western medicine nimodipine for prevention of post-stroke dementia by comparing with clinical conventional treatment methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedFirst Submitted
Initial submission to the registry
August 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2023
CompletedFirst Posted
Study publicly available on registry
August 23, 2023
CompletedAugust 23, 2023
August 1, 2023
2.5 years
August 15, 2023
August 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response Rate
24 weeks
Secondary Outcomes (2)
Hasegawa Dementia Scale
24 weeks
Montreal Cognitive Assessment
24 weeks
Study Arms (2)
treatment group
EXPERIMENTALOn the basis of the control group treatment, the treatment group also adopted the acupuncture treatment
control group
OTHERThe control group received oral nimodipine tablets
Interventions
The control group received oral nimodipine tablets
Eligibility Criteria
You may qualify if:
- Definite ischemic stroke or hemorrhagic stroke confirmed by head CT / MRI examination
- Memory or cognitive and executive dysfunction. Cognitive dysfunction will be determined after the mini mental state evaluation (MMSE) score
- Age limited to 40-85 years, irrespective of gender
- Stable condition, clear consciousness, no aphasia, oral medication available
- No major comorbidity, no major depression
- Consent and signed patient informed consent
You may not qualify if:
- Had serious medical conditions, such as heart, liver, kidney, or endocrine disease
- Aphasia or hearing impairment
- Participants in other clinical trials
- Patients currently on medication to improve cognitive function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Affiliated Hospital of Anhui University of Chinese Medicine
Hefei, Anhui, 230031, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- DOCTOR
Study Record Dates
First Submitted
August 15, 2023
First Posted
August 23, 2023
Study Start
February 1, 2021
Primary Completion
August 1, 2023
Study Completion
August 15, 2023
Last Updated
August 23, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share
At present, we have not made a decision on whether to share all IPD. This is because we need to consider a range of factors, including ethical principles, legal requirements, privacy protection, and data sharing agreements. We are carefully evaluating these factors and will make a clear decision as soon as possible.