ParkinsonismPhase 2NCT05506891
Efficacy and Safety of Astragalus for Non-motor Symptoms of α-Synucleinopathy
A Phase 2 study testing Physical therapy group and Astragalus in people with Parkinsonism, run by Fujian Medical University Union Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Parkinsonism
- What is being tested?
- Physical therapy group and Astragalus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 1 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with a clinical diagnosis of PD, MSA and DLB, with orthostatic hypotension.
- Participants with cognitive disorder.
- Adults signed informed consents.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000
Xiaodong Pan, 059186218341, xieheyb@163.com
About this study
Official title: 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.
- Conditions
- Parkinsonism
- Being tested
- Physical therapy group, Astragalus
- Medical subject headings
- Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy groupBehavioural
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.
AstragalusDrug
After a 2-week washout period, astragalus granules 15g, drunk with warm water, once a day, will be taken for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Astragalus group | Experimental | Not described Receives: Drug: Astragalus |
| Physical therapy group | Active comparator | Not described Receives: Behavioral: Physical therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline vs 3 months after treatment.
Secondary outcomes (15)
OH Questionnaire score
ΔHR/ΔSBP means heart rate (HR) and systolic blood pressure (SBP) from baseline OH Questionnaire score
Measured: 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
Measured: Baseline vs 3 months after treatment.
Change from baseline HRV (ms) at 3months.
Heart rate variability (HRV) was calculated as the maximum bpm - minimum bpm.
Measured: 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
Measured: 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
Measured: Baseline vs 3 months after treatment.
Change from baseline MoCA scores at 3 months.
The Montreal Cognitive Assessment (MoCA)
Measured: Baseline vs 3 months after treatment.
Change from baseline CDR scores at 3 months.
The Clinical Dementia Rating (CDR)
Measured: Baseline vs 3 months after treatment.
Change from baseline RAVLT scores at 3 months.
The Rey Auditory Verbal Learning Test (RAVLT)
Measured: Baseline vs 3 months after treatment.
Change from baseline HAS scores at 3 months.
The Hamilton Anxiety Scale (HAS)
Measured: Baseline vs 3 months after treatment.
Change from baseline HDS scores at 3 months.
The Hamilton Depression Scale (HDS)
Measured: Baseline vs 3 months after treatment.
Change from baseline NPI scores at 3 months.
The Neuropsychiatric Inventory (NPI)
Measured: Baseline vs 3 months after treatment.
Change from the baseline plasma α-synuclein levels (ng/ml) at 3 months.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline vs 3 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Oct 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParkinsonismStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506891
- Sponsor's protocol ID
- AS-PDS
- Status last verified
- Sep 2023
- First submitted
- 9 Aug 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Astragalus for Non-Motor Symptoms of α-Synucleinopathy：an Open-Label Self-Controlled Before-and-After Study
- ClinicalTrials.gov ID
- NCT05506891
- Acronym / sponsor ID
- AS-PDS
- Conditions
- Parkinsonism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Astragalus group | Experimental | Drug: Astragalus |
| Physical therapy group | Active comparator | Behavioral: Physical therapy group |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants with a clinical diagnosis of PD, MSA and DLB, with orthostatic hypotension.
- Participants with cognitive disorder.
- Adults signed informed consents.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapy groupLimit 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. | Behavioural | Physical therapy group |
| AstragalusAfter a 2-week washout period, astragalus granules 15g, drunk with warm water, once a day, will be taken for 3 months. | Drug | Astragalus group |
Primary outcome
Change from baseline mean arterial pressure after 3 minutes of upright posture versus decubitus position (mmHg) at 3 months.
Time frame: Baseline vs 3 months after treatment.
Mean arterial pressure was calculated as ⅓ pulse pressure + diastolic pressure.
15 secondary outcomes
OH Questionnaire score
Time frame: Baseline vs 3 months after treatment.
Change from baseline Rate of change in ΔHR/ΔSBP at 3months.
Time frame: Baseline vs 3 months after treatment.
Change from baseline HRV (ms) at 3months.
Time frame: Baseline vs 3 months after treatment.
Change from baseline decumbent and orthostatic digit span (DDS) difference at 3months.
Time frame: Baseline vs 3 months after treatment.
Change from baseline decumbent and orthostatic character conversion (CDS) difference at 3months.
Time frame: Baseline vs 3 months after treatment.
Change from baseline MoCA scores at 3 months.
Time frame: Baseline vs 3 months after treatment.
Change from baseline CDR scores at 3 months.
Time frame: Baseline vs 3 months after treatment.
Change from baseline RAVLT scores at 3 months.
Time frame: Baseline vs 3 months after treatment.
Change from baseline HAS scores at 3 months.
Time frame: Baseline vs 3 months after treatment.
Change from baseline HDS scores at 3 months.
Time frame: Baseline vs 3 months after treatment.
Change from baseline NPI scores at 3 months.
Time frame: Baseline vs 3 months after treatment.
Change from the baseline plasma α-synuclein levels (ng/ml) at 3 months.
Time frame: Baseline vs 3 months after treatment.
Change from baseline Vic at 3 months.
Time frame: Baseline vs 3 months after treatment.
Change from baseline ODI at 3 months.
Time frame: Baseline vs 3 months after treatment.
Change from baseline PAF (Hz) at 3 months.
Time frame: Baseline vs 3 months after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Physical therapy group and Astragalus in people with Parkinsonism, run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaodong Pan (0591-86218341, pxd77316@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline mean arterial pressure after 3 minutes of upright posture versus decubitus position (mmHg) at 3 months. (time frame: Baseline vs 3 months after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.