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Completed

NCT Number: NCT00251238

Efficacy and Tolerability of Ginkgo Biloba Extract 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UMC ST Radboud

Nijmegen, Gelderland, 6525 GH, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ginkgo biloba extract EGb 761

Drug

daily Ginkgo biloba extract EGb 761

Other names: Ginkgo biloba

Primary outcomes

  1. Frequency of Vasospastic Attacks

    Time frame: Number of Vasospastic Attacks per day, for up to 10 weeks

  2. Duration of Vasospastic Attacks

    Time frame: minutes per day

  3. 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.

Sponsors and collaborators

Lead sponsor

VSM Geneesmiddelen b.v.

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Nov 9, 2005
Registry last updated
May 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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