Clinical trial NCT05506891: Efficacy and Safety of Astragalus for Non-motor Symptoms of α-Synucleinopathy
Official title: Efficacy and Safety of Astragalus for Non-Motor Symptoms of α-Synucleinopathy：an Open-Label Self-Controlled Before-and-After Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Parkinsonism
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline mean arterial pressure after 3 minutes of upright posture versus decubitus position (mmHg) at 3 months.
timeFrame: Baseline vs 3 months after treatment.
Secondary outcomes:
measure: OH Questionnaire score
timeFrame: Baseline vs 3 months after treatment.
measure: Change from baseline Rate of change in ΔHR/ΔSBP at 3months.
timeFrame: Baseline vs 3 months after treatment.
measure: Change from baseline HRV (ms) at 3months.
timeFrame: Baseline vs 3 months after treatment.
measure: Change from baseline decumbent and orthostatic digit span (DDS) difference at 3months.
timeFrame: Baseline vs 3 months after treatment.
measure: Change from baseline decumbent and orthostatic character conversion (CDS) difference at 3months.
timeFrame: Baseline vs 3 months after treatment.
measure: Change from baseline MoCA scores at 3 months.
timeFrame: Baseline vs 3 months after treatment.
measure: Change from baseline CDR scores at 3 months.
timeFrame: Baseline vs 3 months after treatment.
measure: Change from baseline RAVLT scores at 3 months.
timeFrame: Baseline vs 3 months after treatment.
measure: Change from baseline HAS scores at 3 months.
timeFrame: Baseline vs 3 months after treatment.
measure: Change from baseline HDS scores at 3 months.
timeFrame: Baseline vs 3 months after treatment.
measure: Change from baseline NPI scores at 3 months.
timeFrame: Baseline vs 3 months after treatment.
measure: Change from the baseline plasma α-synuclein levels (ng/ml) at 3 months.
timeFrame: Baseline vs 3 months after treatment.
measure: Change from baseline Vic at 3 months.
timeFrame: Baseline vs 3 months after treatment.
measure: Change from baseline ODI at 3 months.
timeFrame: Baseline vs 3 months after treatment.
measure: Change from baseline PAF (Hz) at 3 months.
timeFrame: Baseline vs 3 months after treatment.
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References: