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

NCT05506891 | Unknown Phase 2

• 1 other identifier: AS-PDS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinsonism

Outcome Measures

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.

  Baseline vs 3 months after treatment.

Secondary Outcomes (15)

• OH Questionnaire score

  Baseline vs 3 months after treatment.

• Change from baseline Rate of change in ΔHR/ΔSBP at 3months.

  Baseline vs 3 months after treatment.

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

  Baseline vs 3 months after treatment.

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

  Baseline vs 3 months after treatment.

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

  Baseline vs 3 months after treatment.

Study Arms (2)

Astragalus group

EXPERIMENTAL

Drug: Astragalus

Physical therapy group

ACTIVE COMPARATOR

Behavioral: Physical therapy group

Interventions

Physical therapy group 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.

Physical therapy group

Astragalus DRUG

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

Astragalus group

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with a clinical diagnosis of PD, MSA and DLB, with orthostatic hypotension.
• Participants with cognitive disorder.
• Adults signed informed consents.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

MeSH Terms

Conditions

Parkinsonian Disorders

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Central Study Contacts

Xiaodong Pan

CONTACT

0591-86218341; pxd77316@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 18, 2022
• Study Start: October 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)