Efficacy of Ethnodyne Visio in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in MDS UPDRS III score
研究概览
简要总结
ETHNODYNE VISIO is a food supplement composed of an innovative plant-based active ingredient acting alongside vitamin B2. It is proposed in patients with visual problems. Based on clinical and experimental data, the investigators propose a pilot open study in order to test the efficacy of "Ethnodyne visio" in patients with Parkinson 's disease (PD). The hypothesis is that Ethnodyne visio may improve motor and non motor signs of PD. 24 patients with PD will be evaluated before and after 3 months of add on treatment by Ethnodyne visio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Parkinson disease (PD) with at least 3 years of evolution
- •Hoehn and Yahr score 2 or 3
- •with moderate fluctuations (score 1 or 2 for item 3 score IV MSD UPDRS)
- •with no modification in anti-parkinsonian drugs since at least 1 month
- •minimental test >24
排除标准
- •known intolerance to Ethnodyne visio
- •woman of childbearing potential or breastfeeding
- •anticipated anti-parkinsonian treatment modification during the 3 months of the study
- •antidepressant or anxiolytic drugs modified within one month prior to inclusion visit
- •other chronic disease
- •concomitant participation in a another clinical trial
- •Subject under legal guardianship
研究组 & 干预措施
ETHNODYNE VISIO
Administration 2 times a day of a dietary supplement, as add on therapy, in patients with Parkinson s disease
干预措施: ETHNODYNE VISIO (Dietary Supplement)
结局指标
主要结局
Change in MDS UPDRS III score
时间窗: baseline and following 3 months of treatment
次要结局
- Change in MDS UPDRS I, II and IV score(baseline and following 3 months of treatment)
- Frequency, seriousness and severity of adverse event reactions(during the 3 months of treatment)
- Change in Levodopa equivalent dose treatment (equivalence table)(baseline and following 3 months of treatment)