NCT00461942已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Neuroprotection Effect of Green Tea Polyphenol in De Novo Parkinson's Disease Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- Delay of progression of Motor dysfunction
研究概览
简要总结
The purpose of this study is to determine whether Green Tea Polyphenol, an extraction from Green Tea is effective and safe in the treatment of De Novo Parkinson's disease Patients without taking any antiparkinsonism drug
详细描述
The primary outcome measurement is UPDRS using a delay start design. Total 480 de novo PD patients divided into three dosage groups of green tea polyphenol and one placebo control group. Patients will be treated for one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to give informed consent
- •Age 30 years or older at time of diagnosis of Parkinson's disease
- •Diagnosed as having typical PD
- •Parkinson's disease duration of no more than 5 years
- •No current dopaminergic or other forms of anti-parkinsonism therapy
- •Hoehn and Yahr stage < 3
排除标准
- 未提供
结局指标
主要结局
Delay of progression of Motor dysfunction
次要结局
- Quality of Daily life
- Mood;
- Cognition;
研究者
研究点 (2)
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