Efficacy and Tolerability of Ginkgo Biloba Extract in Patients With Raynaud´s Phenomenon
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Diagnostic
|Official Title:||Efficacy and Tolerability of Ginkgo Biloba Extract EGb 761® in Patients With Raynaud´s Phenomenon|
- Frequency of attacks
- Duration of attacks
- Severity of attacks
- Par- and dysesthesia of fingers or toes
- Coordination problems
- Interaction with daily activities
- Subjective assessment of colour anormalities of fingers
- Impact of attack trigger factors
|Study Start Date:||November 2005|
|Estimated Study Completion Date:||April 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251238
|UMC ST Radboud|
|Nijmegen, Gelderland, Netherlands, 6525 GH|
|Study Director:||Study Department||VSM Geneesmiddelen b.v.|