UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053165 |
|---|---|
| Receipt number | R000060670 |
| Scientific Title | Research on Oral Frail Prevention by Measuring Masticatory Strength |
| Date of disclosure of the study information | 2024/01/19 |
| Last modified on | 2023/12/19 19:02:44 |
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Basic information
Public title
Research on Oral Frail Prevention by Measuring Masticatory Strength
Acronym
Research on Oral Frail Prevention by Measuring Masticatory Strength
Scientific Title
Research on Oral Frail Prevention by Measuring Masticatory Strength
Scientific Title:Acronym
Research on Oral Frail Prevention by Measuring Masticatory Strength
Region
| Japan |
Condition
Condition
Oral hypofunction
Classification by specialty
| Oral surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the prevention of flail from the perspective of oral flail by measuring
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Chewing ability by Gummy jelly for chewing ability measurement
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The pharmacist will measure the chewing ability of the practitioner at the dispensing pharmacy using gummy jellies for measuring chewing ability only once in this study.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients presenting at the pharmacy who have given consent for the study.
Key exclusion criteria
1. Patients who did not give consent for this study among those who visited the pharmacy.
2. Patients for whom there is a risk of further worsening of symptoms or new adverse effects as a result of this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Adachi |
Organization
Tokyo University of Pharmacy and Life Sciences
Division name
School of Pharmacy, Laboratory for Immunopharmacology of Microbial Products
Zip code
192-0392
Address
1432-1 Horinouchi, Hachioji, Tokyo
TEL
042-676-5561
adachiyo@toyaku.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Adachi |
Organization
Tokyo University of Pharmacy and Life Sciences
Division name
School of Pharmacy, Laboratory for Immunopharmacology and Microbial Products
Zip code
192-0392
Address
1432-1 Horinouchi, Hachioji, Tokyo
TEL
042-676-5561
Homepage URL
adachiyo@toyaku.ac.jp
Sponsor or person
Institute
Tokyo University of Pharmacy and Life Sciences
Institute
Department
Personal name
Funding Source
Organization
Tokyo University of Pharmacy and Life Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo University of Pharmacy and Life Sciences
Address
1432-1 Horinouchi, Hachioji, Tokyo
Tel
042-676-5561
adachiyo@toyaku.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
| 2024 | Year | 01 | Month | 19 | 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
| 2024 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 11 | 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
| 2023 | Year | 12 | Month | 19 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060670
