Tokyo, Nov. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059568) 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(exam1)' on Nov. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
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 evaluate the effect of Acanthopanax senticosus Food is beneficial for students in terms of motivation to learn and health maintenance.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Administration of Acanthopanax senticosus Food during 1 month.
Interventions/Control_2 - Administration of placebo Food during 1 month.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Healthy individuals
2. Males and females aged 18 years or older capable of providing informed consent
3. Individuals wishing to participate in this clinical trial
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 - 20
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=R000068095
Disclaimer: Curated by HT Syndication.