Efficacy, Safety and Response Predictors of Adjuvant Astragalus for Cognition in Hypotension
Status:
Recruiting
Trial end date:
2025-05-30
Target enrollment:
Participant gender:
Summary
Background: The presence of hypotension in adults increases their risk of cognitive
impairment. Recent big data studies showed that add-on Astragalus membranaceus (AM) can
effectively improve the state of hypotension. The effectiveness of add-on AM in improving
cognitive function in hypotension has not been established. Therefore, this study aims to
determine the efficacy and safety of add-on AM treatment in improving cognitive function
among hypotension, reveal the underlying mechanisms, and further explore the effective drug
components through network pharmacology.
Methods/design: This is an add-on, assessor-blind, parallel, pragmatic randomized controlled
clinical trial. At least 68 hypotensive adults aged 30 or older will be recruited.
Participants will be randomized 1:1 to receive 24 weeks of add-on astragalus or routine
treatment. Primary efficacy outcome will the changes in the MOCA score, second efficacy
outcomes will include changes in neuropsychological tests, blood pressure, plasma biomarkers,
multimodal electroencephalogram and neuroimaging. Safety outcomes will include physical
examinations, vital signs, electrocardiography, laboratory tests (hematologic tests and blood
chemical values), and adverse events (AEs) records.
Discussion: Considering the possible physical, social, financial, and psychological
consequences of cognitive impairment, we hope to provide insights into the effects of add-on
AM on cognitive function in hypotension. It is projected that add-on AM will significantly
delay the development of cognitive impairment and improve cognitive function compared to the
use of routine treatment alone.