NCT00224263已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of Lingzhi in Patients With Early Parkinson's Disease Receiving Stable L-dopa/DCI
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Motor Function
研究概览
简要总结
The purpose of this study is to determine whether Lingzhi (Ganoderma), a widely used traditional Chinese Medicine is effective and safe in the treatment of Parkinson's disease when combined use with L-dopa.
详细描述
This study is to focus on the effects of Lingzhi on non-motor symptoms of Parkinson's diseases as the primary outcome and on delaying the disease progression using the delay start design as the secondary outcome measurement. Two dosage groups and one placebo control group with total 360 subjects will be recruited. The treatment is 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 80 Years（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
- •have idiopathic Parkinson's disease, defined as:
- •having at least 2 of the following 4 signs: resting tremor, bradykinesia, rigidity, or postural reflex impairment, at least one of which must be resting tremor or bradykinesia
- •no secondary or atypical parkinsonism
- •asymmetric features (current signs or history of asymmetric onset)
- •response to L-dopa, by patient self-report
- •Parkinson's disease duration of no more than 5 years
- •receiving stable therapy of L-dopa/DCI for at least 3 months; acceptable dose range: 250 mg - 1000 mg L-dopa/DCI daily
- •Hoehn and Yahr stage < 4 on stable L-dopa/DCI treatment
排除标准
- •have atypical parkinsonism due to drugs, metabolic disorders, encephalitis, or other neurodegenerative diseases
- •have any other known medical or psychiatric condition that may compromise their participation in the study
- •have taken another investigational drug within 90 days of baseline
- •have a change in dosage of any other antiparkinsonian drug (eg, pramipexole, ropinirole, pergolide, bromocriptine, methylphenidate, anticholinergics, or amantadine) during the study or within 90 days prior to baseline
- •have received treatment with dopamine blocking agents (including neuroleptic agents, antiemetic agents), dopamine-depleting agents (including reserpine or tetrabenazine) within 90 days prior to baseline
- •do not consent to participate
结局指标
主要结局
Motor Function
次要结局
- Cognition
- Mood
- Quality of Daily Life
研究者
研究点 (1)
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