Raynaud Disease
Conditions
Keywords
Raynaud´s phenomenon, Vasospastic attacks, Ginkgo biloba
Brief summary
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.
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.
Interventions
DRUGGinkgo biloba extract EGb 761
daily Ginkgo biloba extract EGb 761
Sponsors
VSM Geneesmiddelen b.v.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group active treatment group, receiving film coated 120 mg Ginkgo Biloba special extract (EGb 761) two times a day for 10 weeks | 21 |
| Control Group Receiving matching placebo | 20 |
| Total | 41 |
Baseline characteristics
| Characteristic | Control Group | Intervention Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 20 Participants | 39 Participants |
| Age, Continuous | 49 years STANDARD_DEVIATION 13 | 47 years STANDARD_DEVIATION 13 | 48 years STANDARD_DEVIATION 13 |
| Region of Enrollment Netherlands | 20 participants | 21 participants | 41 participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 21 | 2 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |
Outcome results
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.
Time frame: Baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change From Baseline in Severity of Vasospastic Attacks | -1.3 units on a scale | Standard Deviation 2.3 |
| Placebo Group | Change From Baseline in Severity of Vasospastic Attacks | -1.3 units on a scale | Standard Deviation 2.4 |
Primary
Duration of Vasospastic Attacks
Time frame: minutes per day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Duration of Vasospastic Attacks | 47.4 minutes | Standard Deviation 63 |
| Placebo Group | Duration of Vasospastic Attacks | 50.9 minutes | Standard Deviation 84.7 |
Primary
Frequency of Vasospastic Attacks
Time frame: Number of Vasospastic Attacks per day, for up to 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Frequency of Vasospastic Attacks | 2.4 attacks per day | Standard Deviation 2.6 |
| Placebo Group | Frequency of Vasospastic Attacks | 2.0 attacks per day | Standard Deviation 1.8 |