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Efficacy of Sophora japonica L. Pill in Subjective Memory Complaints in Healthy Adults: a protocol of randomized, double-blind, placebo-controlled, parallel-group, clinical trial

Year: 2024
Type: article
Study design: Study Protocol
Abstract: Objectives: Subjective memory complaints, increasingly common among older adults, may indicate early cognitive decline or dementia.Sophora japonica L., a herbal medicine in Korean medicine, has shown potential cognitive benefits in preclinical studies through neuroprotective and anti-inflammatory properties.Given limited efficacy of current pharmacological treatments for cognitive impairment and growing interest in natural products, investigating S. japonica extract in humans is warranted.Methods: This randomized, double-blind, placebo-controlled trial will involve 100 participants aged 40-70 years with subjective memory complaints but without diagnosed cognitive impairment.Participants will receive either S. japonica extract (1,250 mg) or placebo daily for 8 weeks.The primary outcome is change in digit span test score, assessing shortterm memory and attention.Secondary outcomes include changes in other cognitive function tests (visual short-term memory, visual learning, and verbal learning), as well as measures of depression (Beck Depression Inventory-II), anxiety (State-Trait Anxiety Inventory-Y), stress (Stress Response Inventory), heart rate variability, and quality of life (EuroQol 5-Dimension-3L).Assessments will be conducted at baseline and after 8 weeks, with safety monitoring throughout the study period.Conclusion: This study will provide evidence on the efficacy and safety of S. japonica extract for improving cognitive function in adults with subjective memory complaints.If proven effective, this supplement could offer a new approach for supporting cognitive health in aging populations.The comprehensive assessment of cognitive, mood, and quality of life outcomes will allow thorough evaluation of its potential benefits.
Language: English
Field: Medicine
Open Access status: diamond
OpenAlex ID: W4405483871
FWCI:
Cites: 26
Cited by:
Related to: 10