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

Not Applicable

Not yet recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Ginkgo Biloba Extract

• Registration Number: NCT06140888
• Lead Sponsor: Yi Yang

Brief Summary

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 Timeline

• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-25
• Last Update Posted: 2024-02-28
• Study Start: 2024-03-15
• Primary Completion: 2026-10-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 356

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The ginkgo biloba extract group	Ginkgo Biloba Extract	Ginkgo biloba extract 8 pills three times per day is administrated.

Primary Outcome Measures

Name	Time	Method
Changes of the Montreal Cognitive Assessment (MoCA) score	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.

Secondary Outcome Measures

Name	Time	Method
Changes of the Mini-Metal State Examination (MMSE) score	180 days	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.
the Montreal Cognitive Assessment (MoCA) score	180 days	MoCA scores range from 0 to 30, with higher MoCA scores indicating better cognitive function.
the Mini-Metal State Examination (MMSE) score	180 days	MMSE scores range from 0 to 30, with higher MMSE scores indicating better cognitive function.
the modified rankin scale (mRS) score	90 days; 180 days	mRS Scores range from 0 to 6, with a higher mRS Score indicating a worse prognosis.