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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by VSM Geneesmiddelen b.v..
Recruitment status was:  Active, not recruiting
Information provided by:
VSM Geneesmiddelen b.v. Identifier:
First received: November 8, 2005
Last updated: February 17, 2006
Last verified: September 2005
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.

Condition Intervention Phase
Raynaud Disease
Drug: Ginkgo biloba extract EGb 761®
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: Efficacy and Tolerability of Ginkgo Biloba Extract EGb 761® in Patients With Raynaud´s Phenomenon

Resource links provided by NLM:

Further study details as provided by VSM Geneesmiddelen b.v.:

Primary Outcome Measures:
  • Frequency of attacks
  • Duration of attacks
  • Severity of attacks

Secondary Outcome Measures:
  • Par- and dysesthesia of fingers or toes
  • Coordination problems
  • Interaction with daily activities
  • Subjective assessment of colour anormalities of fingers
  • Impact of attack trigger factors

Estimated Enrollment: 45
Study Start Date: November 2005
Estimated Study Completion Date: April 2006
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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00251238

UMC ST Radboud
Nijmegen, Gelderland, Netherlands, 6525 GH
Sponsors and Collaborators
VSM Geneesmiddelen b.v.
Study Director: Study Department VSM Geneesmiddelen b.v.
  More Information Identifier: NCT00251238     History of Changes
Other Study ID Numbers: 523052.01.002
Study First Received: November 8, 2005
Last Updated: February 17, 2006

Keywords provided by VSM Geneesmiddelen b.v.:
Raynaud´s phenomenon
Vasospastic attacks
Ginkgo biloba

Additional relevant MeSH terms:
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on April 25, 2017