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

Parkinsonism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05506891
• Other study ID #: AS-PDS
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: September 2023
• Source: Fujian Medical University Union Hospital
• Contact: Xiaodong Pan
• Phone: 0591-86218341
• Email: pxd77316[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinsonian Disorders
• Parkinsonism

Intervention

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.

Drug:
• Astragalus
After a 2-week washout period, astragalus granules 15g, drunk with warm water, once a day, will be taken for 3 months.

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University Union Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ? pulse pressure + diastolic pressure.	Baseline vs 3 months after treatment.
Secondary	OH Questionnaire score	?HR/?SBP means heart rate (HR) and systolic blood pressure (SBP) from baseline OH Questionnaire score	Baseline vs 3 months after treatment.
Secondary	Change from baseline Rate of change in ?HR/?SBP at 3months.	?HR/?SBP means heart rate (HR) and systolic blood pressure (SBP) from baseline lying position to standing for 3 minutes	Baseline vs 3 months after treatment.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Change from baseline MoCA scores at 3 months.	The Montreal Cognitive Assessment (MoCA)	Baseline vs 3 months after treatment.
Secondary	Change from baseline CDR scores at 3 months.	The Clinical Dementia Rating (CDR)	Baseline vs 3 months after treatment.
Secondary	Change from baseline RAVLT scores at 3 months.	The Rey Auditory Verbal Learning Test (RAVLT)	Baseline vs 3 months after treatment.
Secondary	Change from baseline HAS scores at 3 months.	The Hamilton Anxiety Scale (HAS)	Baseline vs 3 months after treatment.
Secondary	Change from baseline HDS scores at 3 months.	The Hamilton Depression Scale (HDS)	Baseline vs 3 months after treatment.
Secondary	Change from baseline NPI scores at 3 months.	The Neuropsychiatric Inventory (NPI)	Baseline vs 3 months after treatment.
Secondary	Change from the baseline plasma a-synuclein levels (ng/ml) at 3 months.		Baseline vs 3 months after treatment.
Secondary	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.
Secondary	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.
Secondary	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.