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

Fujian Medical University (FJMU)

Status and phase: Enrolling; Phase 2

Conditions: Parkinsonism

Treatments: Drug: Astragalus; Behavioral: Physical therapy group

Study type: Interventional

Funder types: Other

Identifiers

NCT05506891

AS-PDS

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Astragalus group

Experimental group

Treatment:

Drug: Astragalus

Physical therapy group

Active Comparator group

Treatment:

Behavioral: Physical therapy group