Tokyo, Aug. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062453) titled 'Effect of a Single Ingestion of Herb Tea on Temporary Psychological Stress: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study' on Aug. 26.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Hokkaido Information University
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of a single ingestion of herb tea on temporary psychological stress in a randomized, double-blind, placebo-controlled, crossover study.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - A single dose of 100 mL of a beverage containing herb extract, followed by a 1-week washout period, and then a single dose of 100 mL of a placebo beverage.
Interventions/Control_2 - A single dose of 100 mL of a placebo beverage, followed by a 1-week washout period, and then a single dose of 100 mL of a beverage containing herb extract.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Subjects who fully understand significance, content and purpose of this study and who agree to participate in this study with a written informed consent.
2. BDI score < 21.
Key exclusion criteria - 1. Current or past history of psychiatric or sleep disorders requiring treatment, medication, or lifestyle guidance.
2. Under physician's advice, treatment, and/or medication for hypertension, dyslipidemia, and/or diabetes.
3. Use of medicine, functional foods, or supplements which affect blood clotting and/or platelet aggregation.
4. Implantable electronic medical devices.
5. Serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, respiratory diseases or infectious diseases requiring reports to the authorities.
6. Major surgical history relevant to the digestive system such as gastrectomy, gastric suturing, or bowel resection.
7. Unusually high/low blood pressure, or abnormal anthropometric or hematological data.
8. Severe anemia.
9. Pre- or post-menopausal women complaining of obvious physical changes.
10. Risk of having allergic reactions to drugs or foods.
11. Regular intake of medicine, functional foods, or supplements which would affect sleep, stress, or fatigue.
12. Regular intake of energy drink or nutritional supplement drinks.
13. Subjects whose lifestyle is planned to change during the study.
14. Low stress response to mental arithmetic tasks.
15. Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
16. Blood donation prior to the study: either 400 mL whole blood within 16 wks (women), 12 wks(men), 200 mL whole blood within 4 wks (men and women), or blood components within 2 wks (men and women).
17. Pregnant or lactating women or those planning to become pregnant.
18. Current participation in other clinical trials, or participation within the last 4 weeks prior to the study.
19. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target Size - 36
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 29 Day
Date of IRB - 2026 Year 06 Month 29 Day
Anticipated trial start date - 2026 Year 09 Month 01 Day
Last follow-up date - 2026 Year 11 Month 20 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071332
Disclaimer: Curated by HT Syndication.
