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Efficacy and Safety of Ginkgo Biloba Extract in Mild Cognitive Impairment and Cerebrovascular Insufficiency

Efficacy and Safety of Ginkgo Biloba Standardized Extract (24% Ginkoflavonoglicozides and 6% Terpenes) in Treatment of Mild Cognitive and Concentration Impairment

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00446485
Enrollment
90
Registered
2007-03-13
Start date
2007-05-31
Completion date
2010-04-30
Last updated
2015-09-28

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

Conditions

Cerebrovascular Insufficiency, Mild Cognitive Impairment

Keywords

ginkgo biloba, cerebrovascular insufficiency, mild cognitive impairment, concentration impairment

Brief summary

The purpose of the study is to determine weather Ginkgo biloba standardized extract (24% ginkoflavonoglicozides and 6% terpenes) is effective in treatment of cognitive and concentration impairment

Detailed description

Inclusion criteria is cerebrovascular insufficiency MNSE\>20. 90 patients are divided into three groups randomly. First group is being administered 120 mg ginkgo biloba extract, second group 60 mg of the extract and the third group has being administered placebo during the period of 6 months. Methods used for evaluation are SCAG, MMSE, MDRS, VFT, CGI, TCD and color Doppler of carotid arteries. Methods used for follow up safety include: routine blood tests, biochemical tests, neurologic and physical examination, vital signs and ECG.

Interventions

DRUGGinkgo biloba standardized extract 24/6

tablets, 120 mg/day (60 mg two times daily) during 6 months

DRUGGinkgo Biloba standardized extract 24/6

tablets, 60 mg/day during 6 months

DRUGplacebo

placebo during 6 months

Sponsors

Milsing d.o.o.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* cerebrovascular insufficiency and mild cognitive disorder (MMSE=20-28)

Exclusion criteria

* pregnancy * cognitive disorder caused by psychological, metabolic endocrine nutritional and heart disorder * alcohol or drug abuse

Design outcomes

Primary

MeasureTime frame
Changes of MMSE6 months
Changes of MDRS6 months
Changes of VFT6 months
Changes of CGI6 months
Changes of SCAG6 months

Secondary

MeasureTime frame
Changes of platelets, hematocrit, prothrombin time, and activated partial tromboplastin time6 months
Changes of total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides6 months
Safety will be assessed according to occurrence of adverse events during the trial6 months
Changes of TCD, and color Doppler of carotid arteries6 months

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026