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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Limit water and sodium intake. Raise the head of the bed. Standardized amount of exercise. Low temperature diet and small meals. Avoid alcohol, coffee and dehydration. The treatment lasted for 3 months.
After a 2-week washout period, astragalus granules 15g, drunk with warm water, once a day, will be taken for 3 months.
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGChange from baseline mean arterial pressure after 3 minutes of upright posture versus decubitus position (mmHg) at 3 months.
Mean arterial pressure was calculated as ⅓ pulse pressure + diastolic pressure.
Time frame: Baseline vs 3 months after treatment.
OH Questionnaire score
ΔHR/ΔSBP means heart rate (HR) and systolic blood pressure (SBP) from baseline OH Questionnaire score
Time frame: Baseline vs 3 months after treatment.
Change from baseline Rate of change in ΔHR/ΔSBP at 3months.
ΔHR/ΔSBP means heart rate (HR) and systolic blood pressure (SBP) from baseline lying position to standing for 3 minutes
Time frame: Baseline vs 3 months after treatment.
Change from baseline HRV (ms) at 3months.
Heart rate variability (HRV) was calculated as the maximum bpm - minimum bpm.
Time frame: Baseline vs 3 months after treatment.
Change from baseline decumbent and orthostatic digit span (DDS) difference at 3months.
DDS is an executive function measurement tool
Time frame: Baseline vs 3 months after treatment.
Change from baseline decumbent and orthostatic character conversion (CDS) difference at 3months.
CDS is an executive function measurement tool
Time frame: Baseline vs 3 months after treatment.
Change from baseline MoCA scores at 3 months.
The Montreal Cognitive Assessment (MoCA)
Time frame: Baseline vs 3 months after treatment.
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Change from baseline CDR scores at 3 months.
The Clinical Dementia Rating (CDR)
Time frame: Baseline vs 3 months after treatment.
Change from baseline RAVLT scores at 3 months.
The Rey Auditory Verbal Learning Test (RAVLT)
Time frame: Baseline vs 3 months after treatment.
Change from baseline HAS scores at 3 months.
The Hamilton Anxiety Scale (HAS)
Time frame: Baseline vs 3 months after treatment.
Change from baseline HDS scores at 3 months.
The Hamilton Depression Scale (HDS)
Time frame: Baseline vs 3 months after treatment.
Change from baseline NPI scores at 3 months.
The Neuropsychiatric Inventory (NPI)
Time frame: Baseline vs 3 months after treatment.
Change from the baseline plasma α-synuclein levels (ng/ml) at 3 months.
Time frame: Baseline vs 3 months after treatment.
Change from baseline Vic at 3 months.
The intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.
Time frame: Baseline vs 3 months after treatment.
Change from baseline ODI at 3 months.
NODDI models the dispersion of axonal fibers with the use of an Orientation Dispersion Index (ODI).
Time frame: Baseline vs 3 months after treatment.
Change from baseline PAF (Hz) at 3 months.
The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.
Time frame: Baseline vs 3 months after treatment.