Efficacy and Safety of Astragalus for Non-motor Symptoms of α-Synucleinopathy

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Astragalus for Non-Motor Symptoms of α-Synucleinopathy：an Open-Label Self-Controlled Before-and-After Study

Conditions
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Parkinsonism

Intervention / Treatment
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* Behavioral: Physical therapy group
* Drug: Astragalus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with a clinical diagnosis of PD, MSA and DLB, with orthostatic hypotension. Participants with cognitive disorder. Adults signed informed consents. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Astragalus group<br> | Drug: Astragalus<br>* After a 2-week washout period, astragalus granules 15g, drunk with warm water, once a day, will be taken for 3 months.<br>|
| Active Comparator: Physical therapy group<br> | Behavioral: Physical therapy group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change 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. | Baseline vs 3 months after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OH Questionnaire score | ΔHR/ΔSBP means heart rate (HR) and systolic blood pressure (SBP) from baseline OH Questionnaire score | 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 | 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. | 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 | 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 | Baseline vs 3 months after treatment. | 
| Change from baseline MoCA scores at 3 months. | The Montreal Cognitive Assessment (MoCA) | Baseline vs 3 months after treatment. | 
| Change from baseline CDR scores at 3 months. | The Clinical Dementia Rating (CDR) | Baseline vs 3 months after treatment. | 
| Change from baseline RAVLT scores at 3 months. | The Rey Auditory Verbal Learning Test (RAVLT) | Baseline vs 3 months after treatment. | 
| Change from baseline HAS scores at 3 months. | The Hamilton Anxiety Scale (HAS) | Baseline vs 3 months after treatment. | 
| Change from baseline HDS scores at 3 months. | The Hamilton Depression Scale (HDS) | Baseline vs 3 months after treatment. | 
| Change from baseline NPI scores at 3 months. | The Neuropsychiatric Inventory (NPI) | 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 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. | 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). | 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. | Baseline vs 3 months after treatment. |