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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinsonism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Astragalus group

Group Type EXPERIMENTAL

Astragalus

Intervention Type DRUG

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

Physical therapy group

Group Type ACTIVE_COMPARATOR

Physical therapy group

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Astragalus

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No