Efficacy and Safety of Astragalus for Non-motor Symptoms of α-Synucleinopathy
- Conditions
- Parkinsonism
- Interventions
- Behavioral: Physical therapy groupDrug: Astragalus
- Registration Number
- NCT05506891
- Lead Sponsor
- Fujian Medical University Union Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Participants with a clinical diagnosis of PD, MSA and DLB, with orthostatic hypotension.
- Participants with cognitive disorder.
- Adults signed informed consents.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Physical therapy group Physical therapy group - Astragalus group Astragalus -
- Primary Outcome Measures
Name Time Method Change from baseline mean arterial pressure after 3 minutes of upright posture versus decubitus position (mmHg) at 3 months. Baseline vs 3 months after treatment. Mean arterial pressure was calculated as ⅓ pulse pressure + diastolic pressure.
- Secondary Outcome Measures
Name Time Method Change from baseline decumbent and orthostatic digit span (DDS) difference at 3months. Baseline vs 3 months after treatment. DDS is an executive function measurement tool
Change from baseline HRV (ms) at 3months. Baseline vs 3 months after treatment. Heart rate variability (HRV) was calculated as the maximum bpm - minimum bpm.
Change from baseline HDS scores at 3 months. Baseline vs 3 months after treatment. The Hamilton Depression Scale (HDS)
Change from baseline CDR scores at 3 months. Baseline vs 3 months after treatment. The Clinical Dementia Rating (CDR)
Change from baseline HAS scores at 3 months. Baseline vs 3 months after treatment. The Hamilton Anxiety Scale (HAS)
OH Questionnaire score Baseline vs 3 months after treatment. ΔHR/ΔSBP means heart rate (HR) and systolic blood pressure (SBP) from baseline OH Questionnaire score
Change from baseline decumbent and orthostatic character conversion (CDS) difference at 3months. Baseline vs 3 months after treatment. CDS is an executive function measurement tool
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. NODDI models the dispersion of axonal fibers with the use of an Orientation Dispersion Index (ODI).
Change from baseline Rate of change in ΔHR/ΔSBP at 3months. Baseline vs 3 months after treatment. ΔHR/ΔSBP means heart rate (HR) and systolic blood pressure (SBP) from baseline lying position to standing for 3 minutes
Change from baseline MoCA scores at 3 months. Baseline vs 3 months after treatment. The Montreal Cognitive Assessment (MoCA)
Change from baseline RAVLT scores at 3 months. Baseline vs 3 months after treatment. The Rey Auditory Verbal Learning Test (RAVLT)
Change from baseline NPI scores at 3 months. Baseline vs 3 months after treatment. The Neuropsychiatric Inventory (NPI)
Change from baseline Vic at 3 months. Baseline vs 3 months after treatment. The intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.
Change from baseline PAF (Hz) at 3 months. Baseline vs 3 months after treatment. The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.
Trial Locations
- Locations (1)
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China