Back to resultsAcupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia
Primary Purpose
Post-stroke Dementia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The control group received oral nimodipine tablets
Sponsored by
About this trial
This is an interventional prevention trial for Post-stroke Dementia focused on measuring randomized controlled trial, post-stroke dementia, Acupuncture, nimodipine
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- The Second Affiliated Hospital of Anhui University of Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
treatment group
control group
Arm Description
On the basis of the control group treatment, the treatment group also adopted the acupuncture treatment
The control group received oral nimodipine tablets
Outcomes
Primary Outcome Measures
Response Rate
Secondary Outcome Measures
Hasegawa Dementia Scale
Montreal Cognitive Assessment
Full Information
NCT ID
NCT06007573
First Posted
August 15, 2023
Last Updated
August 22, 2023
Sponsor
Yuzhen Pan
Collaborators
Department of acupuncture and massage, Nanling Hospital of traditional Chinese Medicine, Nanling County, Wuhu City, Anhui Province
1. Study Identification
Unique Protocol Identification Number
NCT06007573
Brief Title
Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia
Official Title
Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia:a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
August 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yuzhen Pan
Collaborators
Department of acupuncture and massage, Nanling Hospital of traditional Chinese Medicine, Nanling County, Wuhu City, Anhui Province
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Dementia
Keywords
randomized controlled trial, post-stroke dementia, Acupuncture, nimodipine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
On the basis of the control group treatment, the treatment group also adopted the acupuncture treatment
Arm Title
control group
Arm Type
Other
Arm Description
The control group received oral nimodipine tablets
Intervention Type
Drug
Intervention Name(s)
The control group received oral nimodipine tablets
Intervention Description
The control group received oral nimodipine tablets
Primary Outcome Measure Information:
Title
Response Rate
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Hasegawa Dementia Scale
Time Frame
24 weeks
Title
Montreal Cognitive Assessment
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
The Second Affiliated Hospital of Anhui University of Chinese Medicine
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230031
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia
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