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

NCT ID: NCT06140888

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 356 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2027-04-01

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

The ginkgo biloba extract group

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

Group Type: EXPERIMENTAL

Ginkgo Biloba Extract

Intervention Type: DRUG

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

The control group

Standard medical therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ginkgo Biloba Extract

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yi Yang

OTHER

Sponsor Role: lead

Responsible Party

Yi Yang

Associated Dean of the First Hospital of Jilin University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yi Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Central Contacts

Yi Yang, PhD

Role: CONTACT

doctoryangyi@163.com

13756661217 ext. 0086

Zhenni Guo, PhD

Role: CONTACT

zhen1ni2@163.com

18186872986 ext. 0086

Other Identifiers

BEFIT

Identifier Type: -

Identifier Source: org_study_id