Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Changes in Schwab-England scores
研究概览
简要总结
Lingzhi(Ganoderma) is widely used in traditional Chinese medicine. Previous studies indicated that Lingzhi was safe, well tolorated, and improved symptoms as an add-on therapy to levodopa in early Parkinson's disease(PD) patients. Here the investigators design a multicenter, randomized, double-blind, placebo-controlled, delayed-start trial to evaluate the effects of Lingzhi on modifying disease progression in untreated PD patients.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the criteria for "Probable Parkinson's disease" according to 2015 MDS Clinical Diagnostic Criteria for Parkinson's Disease
- •Aged 30-80 years
- •Hoehn-Yahr Stage≤2
- •UPDRS Part III subscores ranging from 10 to 30 points
- •Disease duration of 5 years or less
- •Untreated with antiparkinsonian drugs for at least two weeks preceding the trial
- •Willing to sign the written informed consent
排除标准
- •Atypical or secondary parkinsonism
- •With psychiatric symptoms or a history of psychiatric diseases
- •With cognitive impairment(MMSE score<24)
- •Major liver or kidney dysfunction
- •Participating in other clinical trials within 3 months preceding the current trial
研究组 & 干预措施
Early-start Group
Receiving Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 72 weeks
干预措施: Ganoderma (Drug)
Delayed-start Group
Receiving placebo for 24 weeks followed by Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 48 weeks
干预措施: Ganoderma (Drug)
Delayed-start Group
Receiving placebo for 24 weeks followed by Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 48 weeks
干预措施: Placebos (Drug)
结局指标
主要结局
Changes in Schwab-England scores
时间窗: 72 weeks
Compare changes in Schwab-England scores from baseline to week 72 between early-start group and delayed-start group
Changes in UPDRS Part III subscores
时间窗: 72 weeks
Compare changes in UPDRS part III scores from baseline to week 72 between early-start group and delayed-start group
Ratios of subjects in need of additional antiparkinsonian drugs
时间窗: 72 weeks
Compare ratios of subjects in need of additional antiparkinsonian drugs during the 72 week period between early-start group and delayed-start group
次要结局
- Changes in ADAS-COG scores(72 weeks)