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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: VSM Geneesmiddelen b.v.

Current Primary Outcome:

  • 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.



Original Primary Outcome:

  • Frequency of attacks
  • Duration of attacks
  • Severity of attacks


Current Secondary Outcome:

Original Secondary Outcome:

  • 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


Information By: VSM Geneesmiddelen b.v.

Dates:
Date Received: November 8, 2005
Date Started: November 2005
Date Completion:
Last Updated: May 16, 2017
Last Verified: May 2017