Efficacy and Tolerability of Ginkgo Biloba Extract EGb 761® in Patients With Raynaud´s Phenomenon
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Frequency of Vasospastic Attacks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ginkgo biloba extract EGb 761
Receiving daily Ginkgo biloba extract EGb 761
干预措施: Ginkgo biloba extract EGb 761 (Drug)
Placebo
Receiving daily placebo
干预措施: Ginkgo biloba extract EGb 761 (Drug)
结局指标
主要结局
Frequency of Vasospastic Attacks
时间窗: Number of Vasospastic Attacks per day, for up to 10 weeks
Change From Baseline in Severity of Vasospastic Attacks
时间窗: 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.
Duration of Vasospastic Attacks
时间窗: minutes per day
次要结局
未报告次要终点
研究者
Sebastian JH Bredie, MD, PhD
SJH Bredie, internist, MD, PhD
VSM Geneesmiddelen b.v.