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NCT Number: NCT06140888

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Ginkgo biloba extract

Drug

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

Primary outcomes

  1. Changes of the Montreal Cognitive Assessment (MoCA) score

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. the Montreal Cognitive Assessment (MoCA) score

    Time frame: 180 days

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

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

    Time frame: 180 days

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

  4. the modified rankin scale (mRS) score

    Time frame: 90 days; 180 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Yang, PhD

CONTACT

[email protected]

13756661217 ext. 0086

Zhenni Guo, PhD

CONTACT

[email protected]

18186872986 ext. 0086

Sponsors and collaborators

Lead sponsor

Yi Yang

Other

Registry information

Official study title

Effect of Ginkgo Biloba Extract on Cognitive Function in Acute Ischemic Stroke: a Multicentre, Randomised, Open-label, Blinded-Endpoint Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 20, 2023
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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