The Clinical Application of Clostridium Butyricum Miyairisan for Motor and Non-motor Symptoms in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Hamilton Anxiety Scale (HAM-A)
研究概览
简要总结
This is an open-label, single-center, non-randomized study to assess the efficacy of Clostridium Butyricum Miyairi on the motor and non-motor symptoms of Parkinson's disease
详细描述
The physician will explain the trial procedures in the outpatient, and then obtain the written informed consent to start the interview. And randomly divided into experimental and observation groups, and according to the timing of taking Miyarisan, scale evaluation and sample collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female over 20 years old, diagnosed with Parkinson's disease.
排除标准
- •People with Parkinson's disease Dementia, or Lactose Intolerance
研究组 & 干预措施
Miyarisan-BM (Clostridium Butyricum Miyairi) first
Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year, then stopped for 1 year
干预措施: Miyarisan-BM (Clostridium Butyricum Miyairi) (Drug)
Miyarisan-BM (Clostridium Butyricum Miyairi) later
observation for 1 year and then Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year.
干预措施: Miyarisan-BM (Clostridium Butyricum Miyairi) (Drug)
结局指标
主要结局
Hamilton Anxiety Scale (HAM-A)
时间窗: 0, 3, 12, 15, 24 months
This scale assesses non-motor symptoms in 14 items. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where ≤17 indicates mild anxiety severity, 18-24 indicate mild to moderate anxiety severity, 25-30 indicate moderate to severe anxiety severity, \>30 indicate severe anxiety.
Hamilton Depression Rating Scale (HAM-D)
时间窗: 0, 3, 12, 15, 24 months
This scale assesses non-motor symptoms in 17 items, the total scale value is 50 (Scores 0 to 7 mean normal, 8 to 13 mean mild depression, 14 to 18 mean moderate depression, 19 to 22 mean severe depression, and ≥23 mean very severe depression).
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3
时间窗: 0, 3, 12, 15, 24 months
Part 3 of this scale assesses motor performance in 33 items. Each item is scored on a scale of 0 (normal) to 4 (severe), with a total score range of 0 to 132, and higher scores mean the patient's situation is worse.
次要结局
未报告次要终点