- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00251238
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Gelderland
-
Nijmegen, Gelderland, Netherlands, 6525 GH
- UMC St Radboud
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ginkgo biloba extract EGb 761
Receiving daily Ginkgo biloba extract EGb 761
|
daily Ginkgo biloba extract EGb 761
Other Names:
|
Placebo Comparator: Placebo
Receiving daily placebo
|
daily Ginkgo biloba extract EGb 761
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of Vasospastic Attacks
Time Frame: Number of Vasospastic Attacks per day, for up to 10 weeks
|
Number of Vasospastic Attacks per day, for up to 10 weeks
|
|
Duration of Vasospastic Attacks
Time Frame: minutes per day
|
minutes per day
|
|
Change From Baseline in Severity of Vasospastic Attacks
Time Frame: Baseline and 10 weeks
|
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. |
Baseline and 10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Study Department, VSM Geneesmiddelen b.v.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 523052.01.002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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