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Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06007573
Recruitment Status : Completed
First Posted : August 23, 2023
Last Update Posted : August 23, 2023
Sponsor:
Collaborator:
Department of acupuncture and massage, Nanling Hospital of traditional Chinese Medicine, Nanling County, Wuhu City, Anhui Province
Information provided by (Responsible Party):
Yuzhen Pan, The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Post-stroke Dementia Drug: The control group received oral nimodipine tablets Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia:a Randomized Controlled Trial
Actual Study Start Date : February 1, 2021
Actual Primary Completion Date : August 1, 2023
Actual Study Completion Date : August 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Dementia
Drug Information available for: Nimodipine

Arms and Interventions
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Arm Intervention/treatment
Experimental: treatment group
On the basis of the control group treatment, the treatment group also adopted the acupuncture treatment
 Drug: The control group received oral nimodipine tablets
The control group received oral nimodipine tablets
control group
The control group received oral nimodipine tablets
 Drug: The control group received oral nimodipine tablets
The control group received oral nimodipine tablets


Outcome Measures
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Primary Outcome Measures :
  1. Response Rate [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Hasegawa Dementia Scale [ Time Frame: 24 weeks ]
  2. Montreal Cognitive Assessment [ Time Frame: 24 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Definite ischemic stroke or hemorrhagic stroke confirmed by head CT / MRI examination
  2. Memory or cognitive and executive dysfunction. Cognitive dysfunction will be determined after the mini mental state evaluation (MMSE) score
  3. Age limited to 40-85 years, irrespective of gender
  4. Stable condition, clear consciousness, no aphasia, oral medication available
  5. No major comorbidity, no major depression
  6. Consent and signed patient informed consent

Exclusion Criteria:

  1. Had serious medical conditions, such as heart, liver, kidney, or endocrine disease
  2. Aphasia or hearing impairment
  3. Participants in other clinical trials
  4. Patients currently on medication to improve cognitive function
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06007573


Locations
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China, Anhui
The Second Affiliated Hospital of Anhui University of Chinese Medicine
Hefei, Anhui, China, 230031
Sponsors and Collaborators
Yuzhen Pan
Department of acupuncture and massage, Nanling Hospital of traditional Chinese Medicine, Nanling County, Wuhu City, Anhui Province
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Yuzhen Pan, DOCTOR, The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT06007573    
Other Study ID Numbers: 2021-zj-21
First Posted: August 23, 2023    Key Record Dates
Last Update Posted: August 23, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yuzhen Pan, The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine:
randomized controlled trial
post-stroke dementia
Acupuncture
nimodipine
Additional relevant MeSH terms:
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Stroke
Dementia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurocognitive Disorders
 Mental Disorders
Nimodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents