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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinsonism
• Intervention / Treatment: Behavioral: Physical therapy group; Drug: Astragalus

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaodong Pan; Phone Number: 0591-86218341; Email: pxd77316@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Recruiting
      • Fujian Medical University Union Hospital
      • Contact: Xiaodong Pan; Phone Number: 059186218341; Email: xieheyb@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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 MoCA scores at 3 months.	The Montreal Cognitive Assessment (MoCA)	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.
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 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.
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 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.

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Proteostasis Deficiencies; Parkinsonian Disorders; Synucleinopathies
• Other Study ID Numbers: AS-PDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No