Efficacy and Tolerability of Ginkgo Biloba Extract in Patients With Raynaud´s Phenomenon
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ClinicalTrials.gov Identifier: NCT00251238 |
Recruitment Status
:
Completed
First Posted
: November 9, 2005
Results First Posted
: May 22, 2017
Last Update Posted
: May 22, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Raynaud Disease | Drug: Ginkgo biloba extract EGb 761 | Phase 2 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 41 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Diagnostic |
Official Title: | Efficacy and Tolerability of Ginkgo Biloba Extract EGb 761® in Patients With Raynaud´s Phenomenon |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | March 2006 |
Actual Study Completion Date : | April 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: Ginkgo biloba extract EGb 761
Receiving daily Ginkgo biloba extract EGb 761
|
Drug: Ginkgo biloba extract EGb 761
daily Ginkgo biloba extract EGb 761
Other Name: Ginkgo biloba
|
Placebo Comparator: Placebo
Receiving daily placebo
|
Drug: Ginkgo biloba extract EGb 761
daily Ginkgo biloba extract EGb 761
Other Name: Ginkgo biloba
|
- Frequency of Vasospastic Attacks [ Time Frame: Number of Vasospastic Attacks per day, for up to 10 weeks ]
- Duration of Vasospastic Attacks [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00251238
Netherlands | |
UMC ST Radboud | |
Nijmegen, Gelderland, Netherlands, 6525 GH |
Study Director: | Study Department | VSM Geneesmiddelen b.v. |
Responsible Party: | Sebastian JH Bredie, MD, PhD, SJH Bredie, internist, MD, PhD, VSM Geneesmiddelen b.v. |
ClinicalTrials.gov Identifier: | NCT00251238 History of Changes |
Other Study ID Numbers: |
523052.01.002 |
First Posted: | November 9, 2005 Key Record Dates |
Results First Posted: | May 22, 2017 |
Last Update Posted: | May 22, 2017 |
Last Verified: | May 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Keywords provided by Sebastian JH Bredie, MD, PhD, VSM Geneesmiddelen b.v.:
Raynaud´s phenomenon Vasospastic attacks Ginkgo biloba |
Additional relevant MeSH terms:
Raynaud Disease Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases |