Clinical trial NCT00251238: Efficacy and Tolerability of Ginkgo Biloba Extract in Patients With Raynaud´s Phenomenon
Official title: Efficacy and Tolerability of Ginkgo Biloba Extract EGb 761® in Patients With Raynaud´s Phenomenon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Raynaud Disease
Keywords: Raynaud´s phenomenon
Vasospastic attacks
Ginkgo biloba
Lead sponsor: VSM Geneesmiddelen b.v.
Sponsor class: INDUSTRY
First posted: 2005-11-09
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: Frequency of Vasospastic Attacks
timeFrame: Number of Vasospastic Attacks per day, for up to 10 weeks
measure: Duration of Vasospastic Attacks
timeFrame: minutes per day
measure: Change From Baseline in Severity of Vasospastic Attacks
timeFrame: Baseline and 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: UMC ST Radboud
state: Gelderland
Study officials:
affiliation: VSM Geneesmiddelen b.v.
name: Study Department
role: STUDY_DIRECTOR
References: