Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059902) titled 'Impact of Pre-exam GABA Administration on Stress and Psychophysiological Conditions : A Parallel-Group Comparison Trial' on Nov. 30.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Hoshi University
Condition:
Condition - healthy adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effects of GABA intake on anxiety reduction, sleep quality, and stress reduction.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intervention group: Participants will take one GABA capsule (500 mg) once upon waking.
Interventions/Control_2 - Control group: Participants will take one placebo capsule (containing potato starch) once upon waking.
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - 1. Those who have received sufficient explanation about the purpose and contents of this research, have the ability to provide consent, voluntarily agreed after fully understanding the details, and provided written consent to participate.
2. Individuals who are not currently receiving treatment with psychotropic medications such as anxiolytics or antidepressants.
Key exclusion criteria - 1)Individuals who decline to participate in the study of their own volition.
2)Individuals with known allergies to any of the ingredients of the GABA capsule product.
3)Individuals deemed ineligible at the discretion of the principal
Target Size - 36
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 08 Day
Date of IRB - 2025 Year 07 Month 08 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2026 Year 02 Month 22 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068507
Disclaimer: Curated by HT Syndication.
