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Not yet recruitingNCT06140888Updated Feb 28, 2024

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

An interventional study of Ginkgo Biloba Extract in Acute Ischemic Stroke, sponsored by Yi Yang. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Yi Yang · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
356
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 356 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Yi Yang is the lead sponsor of 41 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
356 participants (estimated)

Study arms

  • Experimental
    The ginkgo biloba extract group

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

    Drug: Ginkgo Biloba Extract

  • No intervention
    The control group

    Standard medical therapy

Interventions

  • DrugGinkgo Biloba Extract

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

06

What researchers measure

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.

    Time frame: 180 days

Secondary outcomes

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

    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.

    Time frame: 180 days

  2. the Montreal Cognitive Assessment (MoCA) score

    MoCA scores range from 0 to 30, with higher MoCA scores indicating better cognitive function.

    Time frame: 180 days

  3. the Mini-Metal State Examination (MMSE) score

    MMSE scores range from 0 to 30, with higher MMSE scores indicating better cognitive function.

    Time frame: 180 days

  4. the modified rankin scale (mRS) score

    mRS Scores range from 0 to 6, with a higher mRS Score indicating a worse prognosis.

    Time frame: 90 days; 180 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06140888
Lead sponsor
Yi Yang
Responsible party
Yi Yang (Associated Dean of the First Hospital of Jilin University, The First Hospital of Jilin University) — Sponsor-investigator
First posted
Nov 20, 2023
Start date
Mar 15, 2024 (estimated)
Primary completion
Oct 1, 2026 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Feb 28, 2024

Study contacts

Yi Yang, PhD
Contact
doctoryangyi@163.com
13756661217 ext. 0086
Zhenni Guo, PhD
Contact
zhen1ni2@163.com
18186872986 ext. 0086
Yi Yang, PhD
principal investigator · The First Hospital of Jilin University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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