Parkinsonism
Conditions
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.
Interventions
BEHAVIORALPhysical therapy group
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.
DRUGAstragalus
After a 2-week washout period, astragalus granules 15g, drunk with warm water, once a day, will be taken for 3 months.
Sponsors
Fujian Medical University Union Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 decumbent and orthostatic character conversion (CDS) difference at 3months. | Baseline vs 3 months after treatment. | CDS is an executive function measurement tool |
| Change from baseline MoCA scores at 3 months. | Baseline vs 3 months after treatment. | The Montreal Cognitive Assessment (MoCA) |
| Change from baseline CDR scores at 3 months. | Baseline vs 3 months after treatment. | The Clinical Dementia Rating (CDR) |
| Change from baseline RAVLT scores at 3 months. | Baseline vs 3 months after treatment. | The Rey Auditory Verbal Learning Test (RAVLT) |
| 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 HDS scores at 3 months. | Baseline vs 3 months after treatment. | The Hamilton Depression Scale (HDS) |
| Change from baseline NPI scores at 3 months. | Baseline vs 3 months after treatment. | The Neuropsychiatric Inventory (NPI) |
| 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. | 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 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 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. |
| Change from baseline HAS scores at 3 months. | Baseline vs 3 months after treatment. | The Hamilton Anxiety Scale (HAS) |
Countries
China
Contacts
Primary ContactXiaodong Pan
Outcome results
None listed