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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Astragalus group | Experimental |
| |
| Physical therapy group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical therapy group | Behavioral | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaodong Pan | Contact | 0591-86218341 | pxd77316@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350000 | China |
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| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Astragalus | Drug | After a 2-week washout period, astragalus granules 15g, drunk with warm water, once a day, will be taken for 3 months. |
|
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. |
| D009069 | Movement Disorders |