A Randomized, Double-Blind, Placebo-Controlled Study of "Xiaoyao Pill" Treatment of Depression in Patients With Parkinson's Disease
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hamilton Depression Scale
研究概览
简要总结
The goal of this study is to evaluate the efficacy of Traditional Chinese Medicine-"Xiaoyao Pill" (Herb extracts)on depression, compared to placebo and "Bupleurum+Ginkgo" in patients with Parkinson's disease.
详细描述
Depression as the most common non-motor comorbidity of Parkinson's disease (PD), have a negative impact on disability and quality of life.
Traditional Chinese Medicine has shown effects on several depression. It is not known if TCM also is effective for depression in PD. This study is to investigate "Xiaoyao Pill", an antidepressant in TCM, on depression in PD.
A total of 60 patients with depression in PD will be randomized to each of the three arms.
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
- •Parkinson's disease without dementia
- •Depression
- •Males or females
- •Willing and able to give informed consent
排除标准
- •cognitive dysfunction
- •other serious diseases
研究组 & 干预措施
group 1
干预措施: Xiaoyao Pill (Drug)
group 2
干预措施: Bupleurum+Ginkgo (Drug)
group 3
干预措施: placebo (Drug)
结局指标
主要结局
Hamilton Depression Scale
时间窗: 12 weeks
Change of Hamilton Depression Scale score on week 12 from baseline.
次要结局
- the Geriatric Depression Scale(12 weeks)
- the responder rate (defined as score reduction of HAMD-17>=50%)(12 weeks)