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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ginkgo biloba extract EGb 761 | Experimental | Receiving daily Ginkgo biloba extract EGb 761 |
|
| Placebo | Placebo Comparator | Receiving daily placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginkgo biloba extract EGb 761 | Drug | daily Ginkgo biloba extract EGb 761 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Vasospastic Attacks | Number of Vasospastic Attacks per day, for up to 10 weeks | |
| Duration of Vasospastic Attacks | minutes per day | |
| Change From Baseline in Severity of Vasospastic Attacks | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Department | VSM Geneesmiddelen b.v. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC ST Radboud | Nijmegen | Gelderland | 6525 GH | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | active treatment group, receiving oral film-coated tablet of 120-mg Ginkgo Biloba special extract (EGb 761) 2 times a day for 10 weeks, after an initial 2-week run-in phase |
| FG001 | Placebo Group | receiving matching placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | active treatment group, receiving film coated 120 mg Ginkgo Biloba special extract (EGb 761) two times a day for 10 weeks |
| BG001 | Control Group | Receiving matching placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Vasospastic Attacks | Posted | Mean | Standard Deviation | attacks per day | Number of Vasospastic Attacks per day, for up to 10 weeks |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | active treatment group (EGb 761) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. SJH Bredie, MD, PhD | Radboud University Nijmegen, The Netherlands | 0031 24 3618819 | bas.bredie@radboudumc.nl |
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| ID | Term |
|---|---|
| D011928 | Raynaud Disease |
| ID | Term |
|---|---|
| D000090122 | Livedoid Vasculopathy |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C063170 | Ginkgo biloba extract |
| D000096983 | Ginkgo Extract |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Duration of Vasospastic Attacks | Posted | Mean | Standard Deviation | minutes | minutes per day |
|
|
|
| Primary | Change From Baseline in Severity of Vasospastic Attacks | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 10 weeks |
|
|
|
| 0 |
| 21 |
| 3 |
| 21 |
| EG001 | Placebo Group | receiving placebo | 0 | 20 | 2 | 20 |
| dyspnoe | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |