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Efficacy and Tolerability of Ginkgo Biloba Extract in Patients With Raynaud´s Phenomenon

Primary Purpose

Raynaud Disease

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Ginkgo biloba extract EGb 761
Sponsored by
VSM Geneesmiddelen b.v.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Raynaud Disease focused on measuring Raynaud´s phenomenon, Vasospastic attacks, Ginkgo biloba

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Primary Raynaud´s phenomenon History of episodic digital or toe pallor Duration of Raynaud´s phenomenon at least 2 years Suffering form regular occuring attacks prior to enrolment Exclusion Criteria: Secondary Raynaud´s phenomenon Connective tissue disease Large vessel disease Cryoglobulinemia, cold agglutinins disease, thrombocytosis Concomitant pharmacological treatment with effects on the vasculature Pregnancy or lactation Severe internal or systemic disease

Sites / Locations

  • UMC ST Radboud

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ginkgo biloba extract EGb 761

Placebo

Arm Description

Receiving daily Ginkgo biloba extract EGb 761

Receiving daily placebo

Outcomes

Primary Outcome Measures

Frequency of Vasospastic Attacks
Duration of Vasospastic Attacks
Change From Baseline in Severity of Vasospastic Attacks
Severity of the complains due to Vasospastic Attacks was measured using a 10-steps likert scale. The scale ranged between 0 and 10, with higher scores indicating more severe attacks.

Secondary Outcome Measures

Full Information

First Posted
November 8, 2005
Last Updated
May 16, 2017
Sponsor
VSM Geneesmiddelen b.v.
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1. Study Identification

Unique Protocol Identification Number
NCT00251238
Brief Title
Efficacy and Tolerability of Ginkgo Biloba Extract in Patients With Raynaud´s Phenomenon
Official Title
Efficacy and Tolerability of Ginkgo Biloba Extract EGb 761® in Patients With Raynaud´s Phenomenon
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VSM Geneesmiddelen b.v.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the study is to investigate the efficacy and safety of EGb 761® in patients with the primary Raynaud phenomenon, with regards to the frequency, duration and severity of vasospastic attacks.
Detailed Description
Despite more than 150 years of research into the pathophysiology of Raynaud´s phenomenon it is still not understood sufficiently. Three mean mechanisms responsible for Raynaud´s phenomenon are discussed and fall into the following three categories: neurological malfunction pathological blood vessel wall and blood cell interactions inflammatory and immunological responses Based on these concepts different classes of drugs have been tested. Although some therapies have shown effects, prolongation of the therapy is often difficult due to side-effects. Considering a prevalence of 5-10% in the general population, there is still a place and probably a need for the development of new treatment concepts. Ginkgo biloba has shown to have anti-oxidative and anti-platelet activities. In a small placebo controlled trial in patients with the Raynaud´s phenomenon promising results for the Ginkgo biloba extract were shown. EGb 761® is known to be safe and well tolerated. Based on the above considerations, EGb 761® may be an effective treatment for Raynaud´s phenomenon. Aim: To determine the efficacy and safety of EGb 761® in patients with Raynaud´s phenomenon on the frequency, duration, and severity of vasospastic attacks compared to placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raynaud Disease
Keywords
Raynaud´s phenomenon, Vasospastic attacks, Ginkgo biloba

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ginkgo biloba extract EGb 761
Arm Type
Experimental
Arm Description
Receiving daily Ginkgo biloba extract EGb 761
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Receiving daily placebo
Intervention Type
Drug
Intervention Name(s)
Ginkgo biloba extract EGb 761
Other Intervention Name(s)
Ginkgo biloba
Intervention Description
daily Ginkgo biloba extract EGb 761
Primary Outcome Measure Information:
Title
Frequency of Vasospastic Attacks
Time Frame
Number of Vasospastic Attacks per day, for up to 10 weeks
Title
Duration of Vasospastic Attacks
Time Frame
minutes per day
Title
Change From Baseline in Severity of Vasospastic Attacks
Description
Severity of the complains due to Vasospastic Attacks was measured using a 10-steps likert scale. The scale ranged between 0 and 10, with higher scores indicating more severe attacks.
Time Frame
Baseline and 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary Raynaud´s phenomenon History of episodic digital or toe pallor Duration of Raynaud´s phenomenon at least 2 years Suffering form regular occuring attacks prior to enrolment Exclusion Criteria: Secondary Raynaud´s phenomenon Connective tissue disease Large vessel disease Cryoglobulinemia, cold agglutinins disease, thrombocytosis Concomitant pharmacological treatment with effects on the vasculature Pregnancy or lactation Severe internal or systemic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Department
Organizational Affiliation
VSM Geneesmiddelen b.v.
Official's Role
Study Director
Facility Information:
Facility Name
UMC ST Radboud
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GH
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Efficacy and Tolerability of Ginkgo Biloba Extract in Patients With Raynaud´s Phenomenon

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