Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Periodical measures of the clinical features with Unified Parkinson Disease Rating Scale (UPDRS) will be done at the beginning, every three months until one year (end of the treatment)
研究概览
简要总结
The purpose of the study is to evaluate whether Viusid/Alzer Nutritional supplements, could improve the progression disease, in patients with Parkinson's Disease (PD).
详细描述
Periodical measures of the clinical features with UPDRS will be done at the beginning, each three months until two years. Each group will be compare to evaluate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinical of PD, with the criteria of Brain Bank of London with early stage.
- •Informed consent.
排除标准
- •Presence of another disease not well controlled.
- •Patient with atypical features.
- •Patient with advanced Parkinson's disease.
研究组 & 干预措施
B
Placebo
干预措施: Placebo (Dietary Supplement)
A
VIUSID/ALZER. The purpose of the study is to evaluate whether Viusid/Alzer Nutritional supplements, could improve the progression disease, in patients with early PD by UPDRS motor
干预措施: VIUSID/ALZER (Dietary Supplement)
结局指标
主要结局
Periodical measures of the clinical features with Unified Parkinson Disease Rating Scale (UPDRS) will be done at the beginning, every three months until one year (end of the treatment)
时间窗: one year
次要结局
- Hoehn-Yarh will be done at the beginning, every three months until one year (end of the treatment)(one year)
- Dosage levodopa will be done at the beginning, every three months until one year (end of the treatment)(one year)