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

VSM Geneesmiddelen

Status and phase: Completed; Phase 2

Conditions: Raynaud Disease

Treatments: Drug: Ginkgo biloba extract EGb 761

Study type: Interventional

Funder types: Industry

Identifiers

NCT00251238

523052.01.002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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41 participants in 2 patient groups, including a placebo group

Ginkgo biloba extract EGb 761

Experimental group

Description:

Receiving daily Ginkgo biloba extract EGb 761

Treatment:

Drug: Ginkgo biloba extract EGb 761

Placebo

Placebo Comparator group

Description:

Receiving daily placebo

Treatment:

Drug: Ginkgo biloba extract EGb 761