Effect of Astragalus Membranaceus on the Improvement of Cognitive Function in Patients With Hypotension

Sponsor

Fujian Medical University Union Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05578443

Collaborator

(none)

Enrollment

Location

Arms

33.9

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The presence of hypotension in older adults increases their risk of cognitive decline. Astragalus membranaceus treatment can effectively improve the state of hypotension. In adults with both hypotension and cognitive impairment, the effectiveness of astragalus in improving their cognitive function has not been established. Therefore, this study aims to determine the efficacy and safety of Astragalus membranaceus treatment in improving cognitive function among patients with cognitive impairment with hypotension.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Impairment	Drug: Astragalus Behavioral: Routine treatment	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Astragalus Membranaceus on the Improvement of Cognitive Function in Patients With Hypotension: a Randomized Controlled Trial Protocol

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jul 30, 2025

Anticipated Study Completion Date :

Jul 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Astragalus membranaceus	Drug: Astragalus Astragalus tablets 20g, warm water to drink, once a day, take for 1 year, during which routine treatment should also be carried out.
Experimental: Routine treatment	Behavioral: Routine treatment 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.
No Intervention: negative control group

Arm

Intervention/Treatment

Experimental: Astragalus membranaceus

Drug: Astragalus

Astragalus tablets 20g, warm water to drink, once a day, take for 1 year, during which routine treatment should also be carried out.

Experimental: Routine treatment

Behavioral: Routine treatment

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.

No Intervention: negative control group

Outcome Measures

Primary Outcome Measures

Change from baseline MoCA scores at 3 months [Baseline vs 3 months after treatment.]
The Montreal Cognitive Assessment (MoCA)

Secondary Outcome Measures

Change from baseline HRV (ms) at 3months [Baseline vs 3 months after treatment.]]
Heart rate variability (HRV) was calculated as the maximum bpm - minimum bpm
The plasma concentration of Cycloastragenol (μg/ml) [Time Frame: 1 hour after treatment.]
Change from the baseline plasma α-synuclein levels (ng/ml) at 3 months [Baseline vs 3 months after treatment.]
Change from baseline Vic at 3 months [Baseline vs 3 months after treatment]
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 [Baseline vs 3 months after treatment]
NODDI models the dispersion of axonal fibers with the use of an Orientation Dispersion Index (ODI)
Change from baseline PAF (Hz) at 3 months [Baseline vs 3 months after treatment]
The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.
Change from baseline mean arterial pressure after 3 minutes of upright posture versus decubitus position (mmHg) at 3 months. [Baseline vs 3 months after treatment]
Mean arterial pressure was calculated as ⅓ pulse pressure + diastolic pressure.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:Participants with a clinical diagnosis of cognitive impairment and orthostatic hypotension. Adults signed informed consents.

Exclusion Criteria:Patients who have one of the following were excluded from this trial:

secondary hypotension.
definite hypersensitivity or contraindication to the study medications.
being treated or history of serious diseases such as stroke or transient ischemic attack, claustrophobia, bipolar disorder, schizophrenia, seizures, drug or alcohol abuse, malignancy, renal failure and dialysis treatment, liver disease (hepatitis), renal disease.
unable to have magnetic resonance imaging (MRI) or electroencephalogram (EEG).
use of health foods, supplements, and medicines that may affect cognitive function, 6) have severe visual and/or hearing impairment.

self-reported use of non-pharmacological or pharmacological therapies to treat hypotension.
during pregnancy or lactation 9) participation in other clinical studies within the past 3 months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fujian Medical University Union Hospital	Fuzhou	Fujian	China	350000

Sponsors and Collaborators

Fujian Medical University Union Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fujian Medical University Union Hospital

ClinicalTrials.gov Identifier:

NCT05578443

Other Study ID Numbers:

AD-AS

First Posted:

Oct 13, 2022

Last Update Posted:

Dec 7, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypotension

Study Results

No Results Posted as of Dec 7, 2022