NCT05506891招募中2 期
Efficacy and Safety of Astragalus for Non-Motor Symptoms of α-Synucleinopathy：an Open-Label Self-Controlled Before-and-After Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline mean arterial pressure after 3 minutes of upright posture versus decubitus position (mmHg) at 3 months.
研究概览
简要总结
α-Synucleinopathy is a cluster of neurodegenerative disease with motor and non-motor symptom. However, there is still a lack of research on the treatment for non-motor symptoms of α-synucleinopathy, especially autonomic dysfunctions such as orthostatic hypotension. Efficacy and safety of astragalus for non-motor symptoms of α-synucleinopathy will be assessed by an open-label self-controlled before-and-after study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a clinical diagnosis of PD, MSA and DLB, with orthostatic hypotension.
- •Participants with cognitive disorder.
- •Adults signed informed consents.
排除标准
- •Patients with history of astragalus allergy.
- •Patients with secondary Parkinsonism that cannot be excluded.
- •Patients with diseases that may cause other types of hypotension or similar symptoms/signs because of hypotension
- •Patients with other medical conditions requiring treatments that may affect blood pressure.
- •Patients with other neurological disorders.
- •Patients with serious comorbidities and immune diseases.
- •Uncooperative patients.
- •Pregnant or lactating women.
研究组 & 干预措施
Astragalus group
Experimental
干预措施: Astragalus (Drug)
Physical therapy group
Active Comparator
干预措施: Physical therapy group (Behavioral)
结局指标
主要结局
Change from baseline mean arterial pressure after 3 minutes of upright posture versus decubitus position (mmHg) at 3 months.
时间窗: Baseline vs 3 months after treatment.
Mean arterial pressure was calculated as ⅓ pulse pressure + diastolic pressure.
次要结局
- Change from baseline decumbent and orthostatic digit span (DDS) difference at 3months.(Baseline vs 3 months after treatment.)
- Change from baseline HRV (ms) at 3months.(Baseline vs 3 months after treatment.)
- Change from baseline HDS scores at 3 months.(Baseline vs 3 months after treatment.)
- Change from baseline CDR scores at 3 months.(Baseline vs 3 months after treatment.)
- Change from baseline HAS scores at 3 months.(Baseline vs 3 months after treatment.)
- OH Questionnaire score(Baseline vs 3 months after treatment.)
- Change from baseline decumbent and orthostatic character conversion (CDS) difference at 3months.(Baseline vs 3 months after treatment.)
- Change from the baseline plasma α-synuclein levels (ng/ml) at 3 months.(Baseline vs 3 months after treatment.)
- Change from baseline ODI at 3 months.(Baseline vs 3 months after treatment.)
- Change from baseline Rate of change in ΔHR/ΔSBP at 3months.(Baseline vs 3 months after treatment.)
- Change from baseline MoCA scores at 3 months.(Baseline vs 3 months after treatment.)
- Change from baseline RAVLT scores at 3 months.(Baseline vs 3 months after treatment.)
- Change from baseline NPI scores at 3 months.(Baseline vs 3 months after treatment.)
- Change from baseline Vic at 3 months.(Baseline vs 3 months after treatment.)
- Change from baseline PAF (Hz) at 3 months.(Baseline vs 3 months after treatment.)
研究者
研究点 (1)
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