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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Raynaud Disease	Drug: Ginkgo biloba extract EGb 761	Phase 2

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	41 participants
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
Study Start Date :	November 2005
Actual Primary Completion Date :	March 2006
Actual Study Completion Date :	April 2006

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	November 9, 2005
Results First Posted:	May 22, 2017
Last Update Posted:	May 22, 2017
Last Verified:	May 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