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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00251238
First Posted: November 9, 2005
Last Update Posted: May 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sebastian JH Bredie, MD, PhD, VSM Geneesmiddelen b.v.
November 8, 2005
November 9, 2005
January 12, 2015
May 22, 2017
May 22, 2017
November 2005
March 2006   (Final data collection date for primary outcome measure)
  • Frequency of Vasospastic Attacks [ Time Frame: Number of Vasospastic Attacks per day, for up to 10 weeks ]
  • Duration of Vasospastic Attacks [ Time Frame: 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.

  • Frequency of attacks
  • Duration of attacks
  • Severity of attacks
Complete list of historical versions of study NCT00251238 on ClinicalTrials.gov Archive Site
Not Provided
  • 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
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Raynaud Disease
Drug: Ginkgo biloba extract EGb 761
daily Ginkgo biloba extract EGb 761
Other Name: Ginkgo biloba
  • Experimental: Ginkgo biloba extract EGb 761
    Receiving daily Ginkgo biloba extract EGb 761
    Intervention: Drug: Ginkgo biloba extract EGb 761
  • Placebo Comparator: Placebo
    Receiving daily placebo
    Intervention: Drug: Ginkgo biloba extract EGb 761
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
April 2006
March 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00251238
523052.01.002
Yes
Not Provided
Plan to Share IPD: Undecided
Sebastian JH Bredie, MD, PhD, VSM Geneesmiddelen b.v.
VSM Geneesmiddelen b.v.
Not Provided
Study Director: Study Department VSM Geneesmiddelen b.v.
VSM Geneesmiddelen b.v.
May 2017

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