Clinical Trial: Effects of Acanthopanax senticosus Harms on anexiety, motivation to learn, quality of sleep, and fatigue associated with learning status in university students - A Randomized, Double-blind, Parallel-group, Placebo-controlled Study - (Japan)

Tokyo, Nov. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059569) titled 'Effects of food containing Acanthopanax senticosus Harms intake on anexiety, motivation to learn, quality of sleep, and fatigue associated with learning status in university students(exam2).' on Nov. 1.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Suzuka University of medicinal Science

Condition: Condition - Healthy subjects Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify whether consumption of Acanthopanax senticosus food reduces psychological stress and enhances learning motivation and efficiency among students. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Single-dose administration of Acanthopanax senticosus food Interventions/Control_2 - Single-dose administration of placebo food

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Healthy individuals 2. Individuals aged 18 or older who have received prior explanation of the study and whose informed consent can be obtained 3. Individuals who wish to participate in the study Key exclusion criteria - 1)Persons who have ingested foods containing Acanthopanax senticosus Harms within 3 months. 2)Persons who comsume health foods or supplements that may affect the study results. 3)Persons with allergies to Acanthopanax senticosus Harms. 4)Persons who are in hospital, on mdication, or undergoing treatment. 5)Persons with alcohol dependence. 6)Persons participating in other clinical studies. 7)Persons with a history of sever hepatic, renal, or cardiac disorders. 8)Persons with pre-existing or current hepatitis. 9)Persons with sever anemia. 10)Persons with hypertension (systolic blood pressure: 180 mmHg or higher, diastolic blood pressure: 90 mmHg or higher). 11)Persons deemed by the principal investigater and sub-investigater to be inappropriate to participate in the study. Target Size - 16

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 22 Day Date of IRB - 2025 Year 07 Month 22 Day Anticipated trial start date - 2025 Year 11 Month 01 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067838

Disclaimer: Curated by HT Syndication.