Efficacy and Tolerability of Ginkgo Biloba Extract in Patients With Raynaud´s Phenomenon
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Raynaud Disease |
Drug: Ginkgo biloba extract EGb 761® |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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
| Estimated Enrollment: | 45 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00251238 History of Changes |
| Other Study ID Numbers: | 523052.01.002 |
| Study First Received: | November 8, 2005 |
| Last Updated: | February 17, 2006 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by VSM Geneesmiddelen b.v.:
|
Raynaud´s phenomenon Vasospastic attacks Ginkgo biloba |
Additional relevant MeSH terms:
|
Raynaud Disease Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013