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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 because the information has not been verified recently.
Verified September 2005 by VSM Geneesmiddelen b.v..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
VSM Geneesmiddelen b.v.
ClinicalTrials.gov Identifier:
NCT00251238
First received: November 8, 2005
Last updated: February 17, 2006
Last verified: September 2005
History of Changes

November 8, 2005
February 17, 2006
November 2005
Not Provided
  • Frequency of attacks
  • Duration of attacks
  • Severity of attacks
Same as current
Complete list of historical versions of study NCT00251238 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Efficacy and Tolerability of Ginkgo Biloba Extract in Patients With Raynaud´s Phenomenon
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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Raynaud Disease
Drug: Ginkgo biloba extract EGb 761®
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
April 2006
Not Provided

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00251238
523052.01.002
Not Provided
Not Provided
VSM Geneesmiddelen b.v.
Not Provided
Study Director: Study Department VSM Geneesmiddelen b.v.
VSM Geneesmiddelen b.v.
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP