Efficacy and Tolerability of Ginkgo Biloba Extract in Patients With Raynaud´s Phenomenon - Full Text View

Sponsor:	VSM Geneesmiddelen b.v.
Information provided by:	VSM Geneesmiddelen b.v.
ClinicalTrials.gov Identifier:	NCT00251238

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 II

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:

MedlinePlus related topics: Raynaud's Disease

Drug Information available for: EGB 761

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

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

Additional relevant MeSH terms:

Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012