Tokyo, Feb. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056988) titled 'Investigation of the Effects of a Reduced Electron Treatment Device on Saliva Secretion' on Feb. 10.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Crane Science Corp.
Condition:
Condition - Male/female adults
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - The device is applied to the parotid gland area for 15 minutes.
Eligibility:
Age-lower limit - 50
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 Size - 20
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064875
Disclaimer: Curated by HT Syndication.
