Acute Ischemic StrokeNCT06140888
Effect of Ginkgo Biloba Extract on Cognitive Function in Acute Ischemic Stroke
A study testing Ginkgo Biloba Extract in people with Acute Ischemic Stroke, run by Yi Yang.
Trial summary
The purpose of this study is to determine the effect of ginkgo biloba extract on cognitive function in acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Ginkgo Biloba Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2024to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a definitive clinical diagnosis of acute ischemic stroke;
- Age≥18 years, regardless of sex；
- Primary education level or higher; baseline MoCA score of 10-25 points;
- Able to complete cognitive scale scoring;
- Informed consent is signed and ginkgo biloba extract therapy is initiated within 14 days of onset.
Who cannot join
- Transient ischemic attack；
- Patients who received emergency reperfusion therapy (including intravenous thrombolysis and endovascular thrombectomy) at onset;
- Combined with other neurological diseases, such as neurodegenerative diseases (e.g., Alzheimer's disease, Parkinson's disease, Lewy body dementia, and frontotemporal dementia), optic neuritis, epilepsy, central nervous system infections (e.g., AIDS and syphilis), traumatic brain injury dementia, etc；
- Currently using psychoactive medications (e.g., antidepressants) or anti-epileptic drugs, or if the time since their last use of these medications was less than 5 half-lives (per the pharmacokinetics of each specific medication; for drugs with unknown half-lives, a 1 month washout period was required)；
- Had a pre-existing diagnosis of a cognitive disorder；
- Currently taking medications intended to improve cognitive function or prevent dementia (e.g., cholinesterase inhibitors, memantine, nootropics), or if the washout period since their last use of these medications was less than 5 half-lives as specified in each drug's pharmacokinetics. For drugs with unknown half-lives, a minimum 1 month washout period was required；
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- Severe liver and kidney dysfunction;
- Active ulcer or bleeding diathesis；
- Allergy to preparations containing ginkgo biloba extract；
- Pregnant or lactating women, patients with a life expectancy less than 6 months, and those unable to complete the study for other reason；
- Unwillingness to be followed up or poor treatment compliance;
- Those who are participating in other clinical investigators, or who have participated in other clinical studies within 3 months prior to enrollment;
- Other conditions that the investigators deemed unsuitable for enrollment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Ginkgo Biloba Extract on Cognitive Function in Acute Ischemic Stroke: a Multicentre, Randomised, Open-label, Blinded-Endpoint Trial
The purpose of this study is to determine the effect of ginkgo biloba extract on cognitive function in acute ischemic stroke.
Read the detailed description
Vascular brain injury is a common post-stroke complication that can reduce cognitive function and lead to vascular cognitive impairment, placing a significant burden on families and society. The purpose of this study is to determine the effect of ginkgo biloba extract on cognitive function in acute ischemic stroke.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Ginkgo Biloba Extract
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginkgo Biloba ExtractDrug
Ginkgo biloba extract 8 pills three times per day is administrated.
| Study group | Role | What they receive |
|---|---|---|
| The ginkgo biloba extract group | Experimental | Ginkgo biloba extract 8 pills three times per day is administrated. Receives: Drug: Ginkgo Biloba Extract |
| The control group | No intervention | Standard medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the Montreal Cognitive Assessment (MoCA) score
The MoCA scores in the 180 day of treatment minus baseline MoCA scores. MoCA scores range from 0 to 30, with higher MoCA scores indicating better cognitive function.
Measured: 180 days
Secondary outcomes (4)
Changes of the Mini-Metal State Examination (MMSE) score
The MMSE scores in the 180 day of treatment minus baseline MMSE scores. MMSE scores range from 0 to 30, with higher MMSE scores indicating better cognitive function.
Measured: 180 days
the Montreal Cognitive Assessment (MoCA) score
MoCA scores range from 0 to 30, with higher MoCA scores indicating better cognitive function.
Measured: 180 days
the Mini-Metal State Examination (MMSE) score
MMSE scores range from 0 to 30, with higher MMSE scores indicating better cognitive function.
Measured: 180 days
the modified rankin scale (mRS) score
mRS Scores range from 0 to 6, with a higher mRS Score indicating a worse prognosis.
Measured: 90 days; 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start15 Mar 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
- Investigators
- Yi Yang, PhD, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140888
- Sponsor's protocol ID
- BEFIT
- Status last verified
- Feb 2024
- First submitted
- 15 Nov 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ginkgo Biloba Extract on Cognitive Function in Acute Ischemic Stroke: a Multicentre, Randomised, Open-label, Blinded-Endpoint Trial
- ClinicalTrials.gov ID
- NCT06140888
- Acronym / sponsor ID
- BEFIT
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 20 Nov 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.
The purpose of this study is to determine the effect of ginkgo biloba extract on cognitive function in acute ischemic stroke.
Detailed description
Vascular brain injury is a common post-stroke complication that can reduce cognitive function and lead to vascular cognitive impairment, placing a significant burden on families and society. The purpose of this study is to determine the effect of ginkgo biloba extract on cognitive function in acute ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The ginkgo biloba extract group | Experimental | Drug: Ginkgo Biloba ExtractGinkgo biloba extract 8 pills three times per day is administrated. |
| The control group | No intervention | –Standard medical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a definitive clinical diagnosis of acute ischemic stroke;
- Age≥18 years, regardless of sex；
- Primary education level or higher; baseline MoCA score of 10-25 points;
- Able to complete cognitive scale scoring;
- Informed consent is signed and ginkgo biloba extract therapy is initiated within 14 days of onset.
Key exclusion criteria (13 listed)
- Transient ischemic attack；
- Patients who received emergency reperfusion therapy (including intravenous thrombolysis and endovascular thrombectomy) at onset;
- Combined with other neurological diseases, such as neurodegenerative diseases (e.g., Alzheimer's disease, Parkinson's disease, Lewy body dementia, and frontotemporal dementia), optic neuritis, epilepsy, central nervous system infections (e.g., AIDS and syphilis), traumatic brain injury dementia, etc；
- Currently using psychoactive medications (e.g., antidepressants) or anti-epileptic drugs, or if the time since their last use of these medications was less than 5 half-lives (per the pharmacokinetics of each specific medication; for drugs with unknown half-lives, a 1 month washout period was required)；
- Had a pre-existing diagnosis of a cognitive disorder；
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 |
|---|---|---|
| Ginkgo Biloba ExtractGinkgo biloba extract 8 pills three times per day is administrated. | Drug | The ginkgo biloba extract group |
Primary outcome
Changes of the Montreal Cognitive Assessment (MoCA) score
Time frame: 180 days
The MoCA scores in the 180 day of treatment minus baseline MoCA scores. MoCA scores range from 0 to 30, with higher MoCA scores indicating better cognitive function.
4 secondary outcomes
Changes of the Mini-Metal State Examination (MMSE) score
Time frame: 180 days
the Montreal Cognitive Assessment (MoCA) score
Time frame: 180 days
the Mini-Metal State Examination (MMSE) score
Time frame: 180 days
the modified rankin scale (mRS) score
Time frame: 90 days; 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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.
Yi Yang, PhD principal investigator
The First Hospital of Jilin University
Questions about this trial
What is this clinical trial studying?
A study testing Ginkgo Biloba Extract in people with Acute Ischemic Stroke, run by Yi Yang.
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 5 inclusion and 13 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: opening soon, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Yang, PhD (13756661217 ext. 0086, doctoryangyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the Montreal Cognitive Assessment (MoCA) score (time frame: 180 days). 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 28 Feb 2024.