UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061308 |
|---|---|
| Receipt number | R000070150 |
| Scientific Title | An empirical study on improving the readability and searchability of package inserts for over-the-counter drugs through generative AI support |
| Date of disclosure of the study information | 2026/04/20 |
| Last modified on | 2026/04/19 10:07:04 |
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Basic information
Public title
An empirical study on improving the readability and searchability of package inserts for over-the-counter drugs through generative AI support
Acronym
GAI-OTC Read/Search Study
Scientific Title
An empirical study on improving the readability and searchability of package inserts for over-the-counter drugs through generative AI support
Scientific Title:Acronym
GAI-OTC Read/Search Study
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
The level of understanding regarding the descriptions in the attached document.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The level of understanding regarding the descriptions in the attached document.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tohru |
| Middle name | |
| Last name | Aomori |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Pharmacy
Zip code
370-0033
Address
60 Nakaorui-machi, Takasaki-shi, Gunma, Japan
TEL
027-352-1180
aomori-t@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tohru |
| Middle name | |
| Last name | Aomori |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Pharmacy
Zip code
370-0033
Address
60 Nakaorui-machi, Takasaki-shi, Gunma, Japan
TEL
027-352-1180
Homepage URL
aomori-t@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Tohru Aomori
Funding Source
Organization
Takasaki University of Health and Welfare
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takasaki University of Health and Welfare
Address
60 Nakaorui-machi, Takasaki-shi, Gunma, Japan
Tel
027-352-1180
aomori-t@takasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 19 | Day |
Last modified on
| 2026 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070150
