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New treatment option for Ischemic Stroke Hospitalized
Official title A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
ClinicalTrials.gov ID: NCT07220538
What this study is testing
What is Extract of Ginkgo Biloba Leaves Tablets 240 mg (2 x 40 mg, t.i.d.)?
Extract of Ginkgo Biloba Leaves Tablets 240 mg (2 x 40 mg, t.i.d.) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ischemic stroke hospitalized.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if Extract of Ginkgo Biloba Leaves Tablets help improve thinking and memory in people aged 55 years and older who had an ischemic stroke (a type of stroke caused by a blocked blood vessel in the brain). It will also look at how safe the Extract of Ginkgo Biloba Leaves Tablets are.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- Male and female participants aged ≥ 55 years who gave their informed consent.
- Non-disabling overt acute ischemic stroke (NIHSS (National Institutes of Health Stroke Scale) ≤ 5, mRS (Modified Rankin Scale) ≤ 2 at the day of...
- Cognitive impairment (MoCA (Montreal Cognitive Assessment)) total score (corrected) \< 23 for participants with up to 12 years of education, or MoCA...
- Sufficient Chinese language skills to understand and respond to all interview questions, complete questionnaires and undergo neuropsychological...
You likely can't join if
- Participation in another experimental drug trial at the same time or within the past 4 weeks before enrollment.
- Aphasia, dysarthria, apraxia or paresis of the dominant upper extremity, severe and insufficiently corrected loss of vision or hearing, severe...
- Pre-stroke cognitive impairment (16-item Informant Questionnaire on Cognitive Decline (IQCODE) score ≥ 3.3), preexisting major neurocognitive...
- Cardiogenic ischemic stroke, atrial fibrillation, or any other conditions that require the intake of anticoagulants.
- Conditions that require the administration of thrombolytics at day of Screening or Visit 1.
- Index acute ischemic stroke with hemorrhagic transformation.
See the full eligibility criteria
- Male and female participants aged ≥ 55 years who gave their informed consent.
- Non-disabling overt acute ischemic stroke (NIHSS (National Institutes of Health Stroke Scale) ≤ 5, mRS (Modified Rankin Scale) ≤ 2 at the day of screening) confirmed by magnetic resonance imaging, and at least 7 but no...
- Cognitive impairment (MoCA (Montreal Cognitive Assessment)) total score (corrected) \< 23 for participants with up to 12 years of education, or MoCA total score \< 22 if more than 12 years of education).
- Sufficient Chinese language skills to understand and respond to all interview questions, complete questionnaires and undergo neuropsychological testing.
- Participation in another experimental drug trial at the same time or within the past 4 weeks before enrollment.
- Aphasia, dysarthria, apraxia or paresis of the dominant upper extremity, severe and insufficiently corrected loss of vision or hearing, severe language difficulties or any other disability that may prevent the...
- Pre-stroke cognitive impairment (16-item Informant Questionnaire on Cognitive Decline (IQCODE) score ≥ 3.3), preexisting major neurocognitive disorder (e. g., dementia due to Alzheimer's disease, vascular dementia...
- Cardiogenic ischemic stroke, atrial fibrillation, or any other conditions that require the intake of anticoagulants.
- Conditions that require the administration of thrombolytics at day of Screening or Visit 1.
- Index acute ischemic stroke with hemorrhagic transformation.
- Intake of traditional Chinese medicines.
- Major neurological disorder, including intracranial hemorrhage, delirium, Parkinson's disease, brain tumor, alcohol-associated brain damage, infectious CNS disease, epilepsy, recent brain trauma, subdural hematoma...
- Major depression or generalized anxiety disorder.
- Active malignant disease.
- Alcohol addiction or substance abuse.
- Known hypersensitivity to Ginkgo biloba, Ginkgo biloba extract or any ingredient of the drug under trial.
- Any circumstances that prevent the participant to be followed up at the scheduled intervals. Hospitalization of the participant for long-term treatment or nursing home placement for bedside care (assisted living...
- Severe comorbidity with life expectancy \< 12 months.
The study team makes the final eligibility decision.
Where it's taking place
- Anyang, China
- Baotou, China
- Beijing, China
- Beipiao, China
- Benxi, China
- Chenzhou, China
- Chifeng, China
- Dalian, China
- Hainan, China
- Harbin, China
- Hebei, China
- Henan, China
- Hengshui, China
- Huizhou, China
- Jiamusi, China
- Jilin City, China
- Jiujiang, China
- Liaocheng, China
- Liuzhou, China
- Luoyang, China
+ 13 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anyang, China; Baotou, China; Beijing, China; Beipiao, China; Benxi, China; Chenzhou, China and 27 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.