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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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 VSM Geneesmiddelen b.v.:

Primary Outcome Measures:
  • Frequency of attacks
  • Duration of attacks
  • Severity of attacks

Secondary Outcome Measures:
  • 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
Estimated Enrollment: 45
Study Start Date: November 2005
Estimated Study Completion Date: April 2006
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
Genders Eligible for Study:   Both
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

No publications provided

ClinicalTrials.gov Identifier: NCT00251238     History of Changes
Other Study ID Numbers: 523052.01.002
Study First Received: November 8, 2005
Last Updated: February 17, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by VSM Geneesmiddelen b.v.:
Raynaud´s phenomenon
Vasospastic attacks
Ginkgo biloba

ClinicalTrials.gov processed this record on March 03, 2015