Post-stroke DementiaNCT06007573
Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia
A study of Post-stroke Dementia, run by Yuzhen Pan at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Post-stroke Dementia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Anhui University of Chinese Medicine
Hefei, Anhui, 230031
About this study
Official title: 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.
- Conditions
- Post-stroke Dementia
- Being tested
- The control group received oral nimodipine tablets
- Keywords
- randomized controlled trial, post-stroke dementia, Acupuncture, nimodipine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The control group received oral nimodipine tabletsDrug
The control group received oral nimodipine tablets
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | On the basis of the control group treatment, the treatment group also adopted the acupuncture treatment Receives: Drug: The control group received oral nimodipine tablets |
| control group | Other | The control group received oral nimodipine tablets Receives: Drug: The control group received oral nimodipine tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Measured: 24 weeks
Secondary outcomes (2)
Hasegawa Dementia Scale
Measured: 24 weeks
Montreal Cognitive Assessment
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Feb 2021
- Primary completion1 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzhen Pan
- Sponsor type
- University, hospital or other
- Collaborators
- Department of acupuncture and massage, Nanling Hospital of traditional Chinese Medicine, Nanling County, Wuhu City, Anhui Province
- Responsible party
- Sponsor-investigator, Yuzhen Pan, The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007573
- Sponsor's protocol ID
- 2021-zj-21
- Status last verified
- Aug 2023
- First submitted
- 15 Aug 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia:a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06007573
- Acronym / sponsor ID
- 2021-zj-21
- Conditions
- Post-stroke Dementia
- Keywords
- randomized controlled trial, post-stroke dementia, Acupuncture, nimodipine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yuzhen PanUniversity, hospital or other
- Collaborators
- Department of acupuncture and massage, Nanling Hospital of traditional Chinese Medicine, Nanling County, Wuhu City, Anhui Province
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: The control group received oral nimodipine tabletsOn the basis of the control group treatment, the treatment group also adopted the acupuncture treatment |
| control group | Other | Drug: The control group received oral nimodipine tabletsThe control group received oral nimodipine tablets |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The control group received oral nimodipine tabletsThe control group received oral nimodipine tablets | Drug | control group, treatment group |
Primary outcome
Response Rate
Time frame: 24 weeks
2 secondary outcomes
Hasegawa Dementia Scale
Time frame: 24 weeks
Montreal Cognitive Assessment
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Post-stroke Dementia, run by Yuzhen Pan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.