UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055652 |
|---|---|
| Receipt number | R000063603 |
| Scientific Title | Evaluation of capsaicin-containing film for improvement of dry mouth in healthy subjects |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/04/25 15:46:31 |
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Basic information
Public title
Evaluation of capsaicin-containing film for improvement of dry mouth in healthy subjects
Acronym
Evaluation of capsaicin-containing film for improvement of dry mouth in healthy subjects
Scientific Title
Evaluation of capsaicin-containing film for improvement of dry mouth in healthy subjects
Scientific Title:Acronym
Evaluation of capsaicin-containing film for improvement of dry mouth in healthy subjects
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of test foods for dry mouth symptoms in healthy subjects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral wetness
Key secondary outcomes
Salivary volume
Tongue pressure
Salivary pH
Oral periodontal disease-related bacteria
Exhaled gas
GOHAI
SF-8
Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Capsaicin-containing film, 3 sheets a day, 2 weeks
Interventions/Control_2
Placebo film, 3 sheets a day, 2 weeks
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Healthy males and females who are at least 50 years old at the time of obtaining consent.
2) Subjects can understand and comply with the rules written in protocol during clinical study period.
3) Subjects whose written informed consent has been obtained.
Key exclusion criteria
1) Subjects diagnosed with oral related diseases such as xerostomia (dry mouth), oral hypofunction.
2) Subjects with hepatic, renal, cardiac, diabetes or other serious diseases.
3) Subjects who judged by a doctor as depression, dementia or mild cognitive impairment.
4) Subjects who have participated in other clinical trials within 84 days prior to the date of consent.
5) Subjects who are judged as unsuitable for this study by the investigator.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Ayanori |
| Middle name | |
| Last name | Yamaki |
Organization
Yamada Bee Company, Inc.
Division name
Functional Ingredient research section, Institute for Bee Products & Health Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-3825
ay1255@yamada-bee.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Suwa |
Organization
Yamada Bee Company, Inc.
Division name
Functional research section, Institute for Bee Products & Health Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-3825
Homepage URL
ds2315@yamada-bee.com
Sponsor or person
Institute
Yamada Bee Company, Inc.
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Research Center for Immunological Analysis, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2024 | Year | 10 | Month | 01 | 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
60
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
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 27 | Day |
Last modified on
| 2025 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063603
