Effect of Ginkgo Biloba Extract on Cognitive Function in Acute Ischemic Stroke

Yi Yang

Status: Not yet enrolling

Conditions: Acute Ischemic Stroke

Treatments: Drug: Ginkgo Biloba Extract

Study type: Interventional

Funder types: Other

Identifiers

NCT06140888

BEFIT

Details and patient eligibility

About

The purpose of this study is to determine the effect of ginkgo biloba extract on cognitive function in acute ischemic stroke.

Full 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.

Enrollment: 356 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with a definitive clinical diagnosis of acute ischemic stroke;
2. Age≥18 years, regardless of sex；
3. Primary education level or higher; baseline MoCA score of 10-25 points;
4. Able to complete cognitive scale scoring;
5. Informed consent is signed and ginkgo biloba extract therapy is initiated within 14 days of onset.

Exclusion criteria

1. Transient ischemic attack；
2. Patients who received emergency reperfusion therapy (including intravenous thrombolysis and endovascular thrombectomy) at onset;
3. 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；
4. 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)；
5. Had a pre-existing diagnosis of a cognitive disorder；
6. 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；
7. Severe liver and kidney dysfunction;
8. Active ulcer or bleeding diathesis；
9. Allergy to preparations containing ginkgo biloba extract；
10. Pregnant or lactating women, patients with a life expectancy less than 6 months, and those unable to complete the study for other reason；
11. Unwillingness to be followed up or poor treatment compliance;
12. Those who are participating in other clinical investigators, or who have participated in other clinical studies within 3 months prior to enrollment;
13. Other conditions that the investigators deemed unsuitable for enrollment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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356 participants in 2 patient groups

The ginkgo biloba extract group

Experimental group

Description:

Ginkgo biloba extract 8 pills three times per day is administrated.

Treatment:

Drug: Ginkgo Biloba Extract

The control group

No Intervention group

Description:

Standard medical therapy