Clinical effect and safety of Ginkgo ester drop pills in the treatment of vascular cognitive impairment: a single-center, double-blinded randomized placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200062451

Enrollment

Unknown

Registered

2022-08-08

Start date

2022-08-01

Completion date

Unknown

Last updated

2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular cognitive impairment,VCI

Interventions

High-dose group:24 ginkgo ketone ester drop pills orally per day (240mg per day)

Low-dose group:12 ginkgo ketone ester drop pills and 12 placebo orally per day (120 mg per day)

Placebo group:24 placebo orally per day

Eligibility

Sex/Gender

All

Age

50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. 50-80 years old; 2. Meet the diagnostic criteria of vascular cognitive impairment, including 3 core elements: (1) Cognitive impairment; (2) Evidence of cerebral vascular injury; (3) It is clear that vascular brain injury plays a dominant role in cognitive impairment. 3. An informed person or caregiver can accompany the subjects to complete the trial; 4. Being able to complete corresponding neuropsychological tests with normal auditory, visual, or language functions; 5. All the enrolled patients and their families have been aware of the study contents and risks All the enrolled patients have signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects with other types of dementia, such as Alzheimer's disease, Lewy body dementia, mixed dementia, which have been diagnosed by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV criteria). subjects with dementia symptoms caused by other causes (mental, metabolic, endocrine, nutritional, tumor or central nervous system infection, etc.); 2. Subjects with other serious systemic diseases (such as uncontrolled hypertension or diabetes, liver and kidney insufficiency, malignant tumor, etc.) or severe mental diseases that prevents patients from completing clinical studies; 3. Subjects with depression (Hamilton Depression Scale > 12 points); Subjects with severe sleep disorders affecting cognitive performance; 4. Subjects who have taken drugs with similar efficacy to this product in the last 6 months.

Design outcomes

Primary

Measure	Time frame
Montreal Cognitive Assessment, MoCA;	—

Secondary

Measure	Time frame
Mini-Mental State Examination, MMSE;Mild Behavioral impairment, MBI;Activities of Daily Living Scale, ADL;Neuropsychiatric Inventory, NPI;Neurofilament light chain, NFL;	—

Countries

China

Contacts

Public ContactYao Xiaoli

The First Affiliated Hospital, Sun Yat-Sen University

yaoxiaol@mail.sysu.edu.cn+86 13527668033

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026