NCT06140888

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
356

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Mar 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Mar 2024Apr 2027

First Submitted

Initial submission to the registry

November 15, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

March 15, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

2.5 years

First QC Date

November 15, 2023

Last Update Submit

February 25, 2024

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Changes of the Montreal Cognitive Assessment (MoCA) score

    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.

    180 days

Secondary Outcomes (4)

  • Changes of the Mini-Metal State Examination (MMSE) score

    180 days

  • the Montreal Cognitive Assessment (MoCA) score

    180 days

  • the Mini-Metal State Examination (MMSE) score

    180 days

  • the modified rankin scale (mRS) score

    90 days; 180 days

Study Arms (2)

The ginkgo biloba extract group

EXPERIMENTAL

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

Drug: Ginkgo Biloba Extract

The control group

NO INTERVENTION

Standard medical therapy

Interventions

Ginkgo Biloba ExtractDRUG

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

The ginkgo biloba extract group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Ginkgo biloba extract

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yi Yang, PhD

    The First Hospital of Jilin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Yang, PhD

CONTACT

13756661217doctoryangyi@163.com

Zhenni Guo, PhD

CONTACT

18186872986zhen1ni2@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associated Dean of the First Hospital of Jilin University

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 20, 2023

Study Start

March 15, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

February 28, 2024

Record last verified: 2024-02