Efficacy and Safety of Ginkgo Biloba Extract in Mild Cogn... | NCT00446485

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Mar 12, 2007

First Submission Date that Met QC Criteria

Mar 12, 2007

First Posted Date

Mar 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2015

Last Update Posted Date

Sep 28, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Professor of Neurology Vida Demarin, MD, PhD, MD, PhD, FAAN, FAHA, FESO Fellow of Croatian Academy of Sciences and Arts Professor of Neurology, Milsing d.o.o.Principal Investigator

Lead Sponsor

Milsing d.o.o.OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Ginkgo Biloba standardized extract 24/6	Drug: Ginkgo biloba standardized extract 24/6
3	Placebo Comparator	placebo	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ginkgo biloba standardized extract 24/6	Drug	tablets, 120 mg/day (60 mg two times daily) during 6 months	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Changes of TCD, and color Doppler of carotid arteries		6 months
Changes of platelets, hematocrit, prothrombin time, and activated partial tromboplastin time		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Department of Neurology, Sestre milosrdnice University Hospital, Vinogradska 29		Zagreb		10000	Croatia

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Professor of Neurology Vida Demarin, MD, PhD, MD, PhD, FAAN, FAHA, FESO Fellow of Croatian Academy of Sciences and Arts Professor of Neurology, Milsing d.o.o.

Unposted Events

Type	Date	Date Unknown
Release	Mar 21, 2017
Reset	Apr 28, 2017

Violation Annotation

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

Estimated Results First Submitted Date

Mar 21, 2017

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D060825	Cognitive Dysfunction
D002561	Cerebrovascular Disorders

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases