UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000056988 |
|---|---|
| Receipt number | R000064875 |
| Scientific Title | Investigation of the Effects of a Reduced Electron Treatment Device on Saliva Secretion |
| Date of disclosure of the study information | 2026/02/10 |
| Last modified on | 2025/02/10 11:35:30 |
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Basic information
Public title
Investigation of the Effects of a Reduced Electron Treatment Device on Saliva Secretion
Acronym
Investigation of the Effects of a Reduced Electron Treatment Device on Saliva Secretion
Scientific Title
Investigation of the Effects of a Reduced Electron Treatment Device on Saliva Secretion
Scientific Title:Acronym
Investigation of the Effects of a Reduced Electron Treatment Device on Saliva Secretion
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the effects of a reduced electron treatment device, which is anticipated to promote saliva secretion, on saliva production.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Saliva volume
Key secondary outcomes
Subjective questionnaire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The device is applied to the parotid gland area for 15 minutes.
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
| 50 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Male and female aged 50 to below 70 years at the time of consent acquisition.
2. Individuals with a saliva volume of 2 to 6 grams at the time of baseline assessment.
3. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria
1. Individuals who regularly use products that could affect the study (such as Food for Specified Health Uses, Foods with Function Claims including reduced coenzyme Q10, or health foods including supplements) more than three times a week and cannot discontinue their use from the time of consent.
2. Individuals who are taking medications (such as antihistamines, antidepressants, or antihypertensives) that might affect the study and cannot limit their use during the study period.
3. Individuals with excessive alcohol intake.
4. Individuals with previous and/or current medical history of serious diseases in the heart, liver, kidney, digestive organs, oral cavity.
5. Individuals with sensory skin disorders, skin abnormalities, susceptibility to Low-temperature burn.
6. Individuals using implantable medical devices such as pacemakers or implantable cardioverter-defibrillators that may be susceptible to electromagnetic interference.
7. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
8. Females who are pregnant or lactating, and those who intend to become pregnant during the trial period.
9. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Saito |
Organization
Crane Science Corp.
Division name
Representative Director
Zip code
104-8139
Address
Pulp and Paper Building, 3-9-11 Ginza, Chuo-ku, Tokyo, Japan
TEL
03-5565-8101
saito@cranescience.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
Crane Science Corp.
Institute
Department
Personal name
Funding Source
Organization
Crane Science Corp.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.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 | 02 | Month | 10 | 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
| 2025 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 10 | Day |
Last modified on
| 2025 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064875
