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

September 24, 2015 updated by: Professor of Neurology Vida Demarin, MD, PhD, Milsing d.o.o.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3
placebo
Drug: placebo
placebo during 6 months
Active Comparator: 1
Ginkgo Biloba standardized extract 24/6
Drug: Ginkgo biloba standardized extract 24/6
tablets, 120 mg/day (60 mg two times daily) during 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes of MDRS
Time Frame: 6 months
6 months
Changes of VFT
Time Frame: 6 months
6 months
Changes of CGI
Time Frame: 6 months
6 months
Changes of SCAG
Time Frame: 6 months
6 months
Changes of MMSE
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes of TCD, and color Doppler of carotid arteries
Time Frame: 6 months
6 months
Changes of platelets, hematocrit, prothrombin time, and activated partial tromboplastin time
Time Frame: 6 months
6 months
Changes of total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides
Time Frame: 6 months
6 months
Safety will be assessed according to occurrence of adverse events during the trial
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milsing d.o.o.

Investigators

  • Principal Investigator: Vida Demarin, MD PHD, University Department of Neurology, Sestre milosrdnice University Hospital, Vinogradska 29, HR-10000 Zagreb, Croatia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

March 12, 2007

First Submitted That Met QC Criteria

March 12, 2007

First Posted (Estimate)

March 13, 2007

Study Record Updates

Last Update Posted (Estimate)

September 28, 2015

Last Update Submitted That Met QC Criteria

September 24, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIL-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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