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

May 16, 2017 updated by: Sebastian JH Bredie, MD, PhD, VSM Geneesmiddelen b.v.

Efficacy and Tolerability of Ginkgo Biloba Extract EGb 761® in Patients With Raynaud´s Phenomenon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

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

    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GH
        • UMC St Radboud

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ginkgo biloba extract EGb 761
Receiving daily Ginkgo biloba extract EGb 761
daily Ginkgo biloba extract EGb 761
Other Names:
  • Ginkgo biloba
Placebo Comparator: Placebo
Receiving daily placebo
daily Ginkgo biloba extract EGb 761
Other Names:
  • Ginkgo biloba

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Vasospastic Attacks
Time Frame: Number of Vasospastic Attacks per day, for up to 10 weeks
Number of Vasospastic Attacks per day, for up to 10 weeks
Duration of Vasospastic Attacks
Time Frame: minutes per day
minutes per day
Change From Baseline in Severity of Vasospastic Attacks
Time Frame: Baseline and 10 weeks

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.

Baseline and 10 weeks

Collaborators and Investigators

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

Investigators

  • Study Director: Study Department, VSM Geneesmiddelen b.v.

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

November 1, 2005

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

November 8, 2005

First Submitted That Met QC Criteria

November 8, 2005

First Posted (Estimate)

November 9, 2005

Study Record Updates

Last Update Posted (Actual)

May 22, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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