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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sebastian JH Bredie, MD, PhD, VSM Geneesmiddelen b.v.
ClinicalTrials.gov Identifier:
NCT00251238
First received: November 8, 2005
Last updated: May 16, 2017
Last verified: May 2017
History of Changes
  Purpose
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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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:

U.S. FDA Resources

Further study details as provided by Sebastian JH Bredie, MD, PhD, VSM Geneesmiddelen b.v.:

Primary Outcome Measures:
  • 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.
Enrollment: 41
Study Start Date: November 2005
Study Completion Date: April 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ginkgo biloba extract EGb 761
Receiving daily Ginkgo biloba extract EGb 761
 Drug: Ginkgo biloba extract EGb 761
daily Ginkgo biloba extract EGb 761
Other Name: Ginkgo biloba
Placebo Comparator: Placebo
Receiving daily placebo
 Drug: Ginkgo biloba extract EGb 761
daily Ginkgo biloba extract EGb 761
Other Name: Ginkgo biloba

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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251238

Locations
Netherlands
UMC ST Radboud
Nijmegen, Gelderland, Netherlands, 6525 GH
Sponsors and Collaborators
VSM Geneesmiddelen b.v.
Investigators
Study Director: Study Department VSM Geneesmiddelen b.v.
  More Information

Responsible Party: Sebastian JH Bredie, MD, PhD, SJH Bredie, internist, MD, PhD, VSM Geneesmiddelen b.v.
ClinicalTrials.gov Identifier: NCT00251238     History of Changes
Other Study ID Numbers: 523052.01.002
Study First Received: November 8, 2005
Results First Received: January 12, 2015
Last Updated: May 16, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sebastian JH Bredie, MD, PhD, VSM Geneesmiddelen b.v.:
Raynaud´s phenomenon
Vasospastic attacks
Ginkgo biloba

Additional relevant MeSH terms:
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2017