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

Primary Purpose

Parkinsonism

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Physical therapy group
Astragalus
Sponsored by
Fujian Medical University Union Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinsonism

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants with a clinical diagnosis of primary Parkinsonism and orthostatic hypotension.
  • 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.

Sites / Locations

  • Fujian Medical University Union HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Astragalus group

Physical therapy group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

OH Questionnaire score
ΔHR/ΔSBP means heart rate (HR) and systolic blood pressure (SBP) from baseline OH Questionnaire score
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
Change from baseline HRV (ms) at 3months.
Heart rate variability (HRV) was calculated as the maximum bpm - minimum bpm.
Change from baseline decumbent and orthostatic digit span (DDS) difference at 3months.
DDS is an executive function measurement tool
Change from baseline decumbent and orthostatic character conversion (CDS) difference at 3months.
CDS is an executive function measurement tool
Change from baseline MoCA scores at 3 months.
The Montreal Cognitive Assessment (MoCA)
Change from baseline CDR scores at 3 months.
The Clinical Dementia Rating (CDR)
Change from baseline RAVLT scores at 3 months.
The Rey Auditory Verbal Learning Test (RAVLT)
Change from baseline HAS scores at 3 months.
The Hamilton Anxiety Scale (HAS)
Change from baseline HDS scores at 3 months.
The Hamilton Depression Scale (HDS)
Change from baseline NPI scores at 3 months.
The Neuropsychiatric Inventory (NPI)
Change from the baseline plasma α-synuclein levels (ng/ml) at 3 months.
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.
Change from baseline ODI at 3 months.
NODDI models the dispersion of axonal fibers with the use of an Orientation Dispersion Index (ODI).
Change from baseline PAF (Hz) at 3 months.
The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.

Full Information

First Posted
August 9, 2022
Last Updated
September 11, 2023
Sponsor
Fujian Medical University Union Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05506891
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Medical University Union Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinsonism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Astragalus group
Arm Type
Experimental
Arm Title
Physical therapy group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Physical therapy group
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Astragalus
Intervention Description
After a 2-week washout period, astragalus granules 15g, drunk with warm water, once a day, will be taken for 3 months.
Primary Outcome Measure Information:
Title
Change from baseline mean arterial pressure after 3 minutes of upright posture versus decubitus position (mmHg) at 3 months.
Description
Mean arterial pressure was calculated as ⅓ pulse pressure + diastolic pressure.
Time Frame
Baseline vs 3 months after treatment.
Secondary Outcome Measure Information:
Title
OH Questionnaire score
Description
ΔHR/ΔSBP means heart rate (HR) and systolic blood pressure (SBP) from baseline OH Questionnaire score
Time Frame
Baseline vs 3 months after treatment.
Title
Change from baseline Rate of change in ΔHR/ΔSBP at 3months.
Description
ΔHR/ΔSBP means heart rate (HR) and systolic blood pressure (SBP) from baseline lying position to standing for 3 minutes
Time Frame
Baseline vs 3 months after treatment.
Title
Change from baseline HRV (ms) at 3months.
Description
Heart rate variability (HRV) was calculated as the maximum bpm - minimum bpm.
Time Frame
Baseline vs 3 months after treatment.
Title
Change from baseline decumbent and orthostatic digit span (DDS) difference at 3months.
Description
DDS is an executive function measurement tool
Time Frame
Baseline vs 3 months after treatment.
Title
Change from baseline decumbent and orthostatic character conversion (CDS) difference at 3months.
Description
CDS is an executive function measurement tool
Time Frame
Baseline vs 3 months after treatment.
Title
Change from baseline MoCA scores at 3 months.
Description
The Montreal Cognitive Assessment (MoCA)
Time Frame
Baseline vs 3 months after treatment.
Title
Change from baseline CDR scores at 3 months.
Description
The Clinical Dementia Rating (CDR)
Time Frame
Baseline vs 3 months after treatment.
Title
Change from baseline RAVLT scores at 3 months.
Description
The Rey Auditory Verbal Learning Test (RAVLT)
Time Frame
Baseline vs 3 months after treatment.
Title
Change from baseline HAS scores at 3 months.
Description
The Hamilton Anxiety Scale (HAS)
Time Frame
Baseline vs 3 months after treatment.
Title
Change from baseline HDS scores at 3 months.
Description
The Hamilton Depression Scale (HDS)
Time Frame
Baseline vs 3 months after treatment.
Title
Change from baseline NPI scores at 3 months.
Description
The Neuropsychiatric Inventory (NPI)
Time Frame
Baseline vs 3 months after treatment.
Title
Change from the baseline plasma α-synuclein levels (ng/ml) at 3 months.
Time Frame
Baseline vs 3 months after treatment.
Title
Change from baseline Vic at 3 months.
Description
The intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.
Time Frame
Baseline vs 3 months after treatment.
Title
Change from baseline ODI at 3 months.
Description
NODDI models the dispersion of axonal fibers with the use of an Orientation Dispersion Index (ODI).
Time Frame
Baseline vs 3 months after treatment.
Title
Change from baseline PAF (Hz) at 3 months.
Description
The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.
Time Frame
Baseline vs 3 months after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaodong Pan
Phone
0591-86218341
Email
pxd77316@163.com
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Pan
Phone
059186218341
Email
xieheyb@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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