- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00446485
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
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
-
-
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Zagreb, Croatia, 10000
- University Department of Neurology, Sestre milosrdnice University Hospital, Vinogradska 29
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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
|
placebo during 6 months
|
Active Comparator: 1
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
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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