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RecruitingNCT05506891Updated Sep 13, 2023

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

A Phase 2 interventional study of Physical therapy group and Astragalus in Parkinsonism, sponsored by Fujian Medical University Union Hospital. Recruiting at 1 site in China. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by Fujian Medical University Union Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 4 months ago, but the record still lists the study as recruiting.

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Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
30 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 21 studies in Parkinsonian Disorders with a site in China — 17 open to participants now, 17 under way, none of them phase 3. Parkinsonian Disorders · China.

Planned enrollment
11th of 14
40 · median 59
Started
2023
with 3 others
Phase 2
Only one
of the 21
Primary completion
2024-07
later than 0 of 16 live
Registered
5th of 21
by date
Lead sponsor
1 of 21
Fujian Medical University Union Hospital

Among the 21 studies in Parkinsonian Disorders with a site in China, this one is the 11th largest by planned enrollment of the 14 interventional ones that give a count, is one of 4 that started in 2023, is the only one in phase 2, reaches primary completion later than 0 of the 16 other live ones, and was the 5th registered.

Parkinsonian Disorders

218 studies on the registry are indexed under Parkinsonian Disorders; 63 are open to participants now.

Browse Parkinsonian Disorders studies →

Open to participants now

17 of the 21 studies in Parkinsonian Disorders with a site in China are open now. Recruiting first, the newest first:

11 more — sign in →

All 17 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 45 Parkinsonian Disorders studies recruiting now, 18 (40%) set no upper age limit and 9 (20%) stop at 75 or younger; 4 take children under 18; 12 take healthy volunteers.

This study: 30 Years to 85 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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.

03

Conditions studied

  • Parkinsonism
04

Who can participate

Ages eligible
30 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Astragalus group

    Drug: Astragalus

  • Active comparator
    Physical therapy group

    Behavioral: Physical therapy group

Interventions

  • BehavioralPhysical 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.

  • DrugAstragalus

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline vs 3 months after treatment.

Secondary outcomes

  1. OH Questionnaire score

    ΔHR/ΔSBP means heart rate (HR) and systolic blood pressure (SBP) from baseline OH Questionnaire score

    Time frame: Baseline vs 3 months after treatment.

  2. 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

    Time frame: Baseline vs 3 months after treatment.

  3. Change from baseline HRV (ms) at 3months.

    Heart rate variability (HRV) was calculated as the maximum bpm - minimum bpm.

    Time frame: Baseline vs 3 months after treatment.

  4. Change from baseline decumbent and orthostatic digit span (DDS) difference at 3months.

    DDS is an executive function measurement tool

    Time frame: Baseline vs 3 months after treatment.

  5. Change from baseline decumbent and orthostatic character conversion (CDS) difference at 3months.

    CDS is an executive function measurement tool

    Time frame: Baseline vs 3 months after treatment.

  6. Change from baseline MoCA scores at 3 months.

    The Montreal Cognitive Assessment (MoCA)

    Time frame: Baseline vs 3 months after treatment.

  7. Change from baseline CDR scores at 3 months.

    The Clinical Dementia Rating (CDR)

    Time frame: Baseline vs 3 months after treatment.

  8. Change from baseline RAVLT scores at 3 months.

    The Rey Auditory Verbal Learning Test (RAVLT)

    Time frame: Baseline vs 3 months after treatment.

  9. Change from baseline HAS scores at 3 months.

    The Hamilton Anxiety Scale (HAS)

    Time frame: Baseline vs 3 months after treatment.

  10. Change from baseline HDS scores at 3 months.

    The Hamilton Depression Scale (HDS)

    Time frame: Baseline vs 3 months after treatment.

  11. Change from baseline NPI scores at 3 months.

    The Neuropsychiatric Inventory (NPI)

    Time frame: Baseline vs 3 months after treatment.

  12. Change from the baseline plasma α-synuclein levels (ng/ml) at 3 months.

    Time frame: Baseline vs 3 months after treatment.

  13. 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.

    Time frame: Baseline vs 3 months after treatment.

  14. Change from baseline ODI at 3 months.

    NODDI models the dispersion of axonal fibers with the use of an Orientation Dispersion Index (ODI).

    Time frame: Baseline vs 3 months after treatment.

  15. Change from baseline PAF (Hz) at 3 months.

    The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.

    Time frame: Baseline vs 3 months after treatment.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2023; primary completion for Jul 2024, 9 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2022
First posted
Aug 18, 2022
StartEst.
Oct 1, 2023
Primary completionEst.
Jul 1, 2024
CompletionEst.
Jul 1, 2024
Last update
Sep 13, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05506891
Responsible party
Sponsor
First posted
Aug 18, 2022
Start date
Oct 1, 2023 (estimated)
Primary completion
Jul 1, 2024 (estimated)
Completion
Jul 1, 2024 (estimated)
Last update
Sep 13, 2023

Study contacts

Xiaodong Pan
Contact
pxd77316@163.com
0591-86218341

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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