Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia

August 22, 2023 updated by: Yuzhen Pan

Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia:a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230031
        • The Second Affiliated Hospital of Anhui University of Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
Other: control group
The control group received oral nimodipine tablets
Drug: The control group received oral nimodipine tablets
The control group received oral nimodipine tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response Rate
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Hasegawa Dementia Scale
Time Frame: 24 weeks
24 weeks
Montreal Cognitive Assessment
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzhen Pan

Collaborators

Department of acupuncture and massage, Nanling Hospital of traditional Chinese Medicine, Nanling County, Wuhu City, Anhui Province

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

August 15, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-zj-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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