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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Raynaud Disease

Intervention / Treatment
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* Drug: Ginkgo biloba extract EGb 761


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ginkgo biloba extract EGb 761<br>Receiving daily Ginkgo biloba extract EGb 761 | Drug: Ginkgo biloba extract EGb 761<br>* daily Ginkgo biloba extract EGb 761<br>* Other names: Ginkgo biloba;|
| Placebo Comparator: Placebo<br>Receiving daily placebo | Drug: Ginkgo biloba extract EGb 761<br>* daily Ginkgo biloba extract EGb 761<br>* Other names: Ginkgo biloba;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Vasospastic Attacks |  | Number of Vasospastic Attacks per day, for up to 10 weeks | 
| Duration of Vasospastic Attacks |  | minutes per day | 
| Change From Baseline in Severity of Vasospastic Attacks | 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. | Baseline and 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ginkgo biloba, Raynaud´s phenomenon, Vasospastic attacks