Tokyo, April 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061308) titled 'An empirical study on improving the readability and searchability of package inserts for over-the-counter drugs through generative AI support' on April 20.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Takasaki University of Health and Welfare

Condition: Condition - Not applicable Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In addition to the attached document, generative AI shall be utilized as an auxiliary information-provision tool, and its impact, through interactive information presentation, on consumers' level of understanding and behavioral choices, as well as the inherent risks, shall be examined empirically. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Participants shall be randomly allocated into two groups. Group A (the generative AI-assisted group) shall view the existing OTC drug package insert (Appendix 1) while receiving support from generative AI (Notebook LM) and respond to the questions. Interventions/Control_2 - Group B (the control group) shall respond to the questions while referring to the same package insert as Group A, without using generative AI.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (1) Individuals aged 18 years or older. (2) Individuals who have provided written consent to participate in this study based on their own free will. Key exclusion criteria - (1) Individuals who have difficulty reading Japanese text. (2) Individuals who are medical professionals, such as physicians, dentists, nurses, physical therapists, registered dietitians, pharmacists, etc.; students of medical faculties or departments; registered sales clerks; and veterinarians. (3) Individuals who have used ibuprofen within the six months preceding the date of the interview survey. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 06 Day Date of IRB - 2026 Year 04 Month 06 Day Anticipated trial start date - 2026 Year 04 Month 23 Day Last follow-up date - 2026 Year 08 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070150

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