Effect of Ginkgo Biloba Extract on Cognitive Function in Acute Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ginkgo Biloba Extract.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Ginkgo Biloba Extract on Cognitive Function in Acute Ischemic Stroke: a Multicentre, Randomised, Open-label, Blinded-Endpoint Trial
Overview
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.
Interventions
- Drug Ginkgo Biloba Extract
Ginkgo biloba extract 8 pills three times per day is administrated.
Primary outcome measures
- Changes of the Montreal Cognitive Assessment (MoCA) score [Time frame: 180 days]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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；
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06140888 · BEFIT