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

NCT ID: NCT00446485

Last Updated: 2015-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-04-30

Brief Summary

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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

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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.

Conditions

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Mild Cognitive Impairment Cerebrovascular Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Ginkgo Biloba standardized extract 24/6

Group Type ACTIVE_COMPARATOR

Ginkgo biloba standardized extract 24/6

Intervention Type DRUG

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

Ginkgo Biloba standardized extract 24/6

Intervention Type DRUG

tablets, 60 mg/day during 6 months

3

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo during 6 months

Interventions

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Ginkgo biloba standardized extract 24/6

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

Intervention Type DRUG

Ginkgo Biloba standardized extract 24/6

tablets, 60 mg/day during 6 months

Intervention Type DRUG

placebo

placebo during 6 months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Milsing d.o.o.

OTHER

Sponsor Role lead

Responsible Party

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Professor of Neurology Vida Demarin, MD, PhD

MD, PhD, FAAN, FAHA, FESO Fellow of Croatian Academy of Sciences and Arts Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vida Demarin, MD PHD

Role: PRINCIPAL_INVESTIGATOR

University Department of Neurology, Sestre milosrdnice University Hospital, Vinogradska 29, HR-10000 Zagreb, Croatia

Locations

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University Department of Neurology, Sestre milosrdnice University Hospital, Vinogradska 29

Zagreb, , Croatia

Site Status

Countries

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Croatia

Other Identifiers

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MIL-001

Identifier Type: -

Identifier Source: org_study_id

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