Title
Efficacy and Tolerability of Ginkgo Biloba Extract in Patients With Raynaud´s Phenomenon
Efficacy and Tolerability of Ginkgo Biloba Extract EGb 761® in Patients With Raynaud´s Phenomenon
Phase
Phase 2Lead Sponsor
VSM Geneesmiddelen b.v.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Raynaud DiseaseIntervention/Treatment
yinhsing ...Study Participants
41The 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.
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.
Receiving daily Ginkgo biloba extract EGb 761
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
| Event Type | Organ System | Event Term | Intervention Group | Placebo Group |
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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.
