Unique ID issued by UMIN | UMIN000053223 |
---|---|
Receipt number | R000060742 |
Scientific Title | Effects of using an electric potential treatment instrument on bowel movements and sleep quality in healthy Japanese: an open-label study |
Date of disclosure of the study information | 2023/12/26 |
Last modified on | 2024/03/15 10:08:45 |
Effects of using an electric potential treatment instrument on bowel movements and sleep quality in healthy Japanese
Effects of using an electric potential treatment instrument on bowel movements and sleep quality in healthy Japanese
Effects of using an electric potential treatment instrument on bowel movements and sleep quality in healthy Japanese: an open-label study
Effects of using an electric potential treatment instrument on bowel movements and sleep quality in healthy Japanese
Japan |
Healthy Japanese
Not applicable | Adult |
Others
NO
To verify the effects of use of the test product on sleep quality as well as the secondary effects on bowel movements
Efficacy
Confirmatory
Pragmatic
Not applicable
1. Sleep test after intervention
1. The "sleepiness on rising," "initiation and maintenance of sleep," "frequent dreaming," "refreshing," "sleep length" and each item in the OSA sleep inventory MA version (OSA-MA) after intervention
2. The number of days with defecation, the defecation frequency, and the amount of defecation after intervention
3. Stool shape, stool color, stool smell, and exhilarating feeling of defecation after intervention
4. Body temperature upon waking after intervention
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Device,equipment |
<Duration>
Non-intervention: Four weeks
Intervention: Four weeks
<Test product>
t.CURE-14000
<Administration>
Use once a day for 60 minutes.
*If you forget to use the test product, use it as soon as you remember. If you cannot be used, record it in the diary
18 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
Individuals who
1. are undergoing medical treatment or have a medical history of malignant tumor or cardiovascular disease, such as heart failure, myocardial infarction, cardiac arrhythmia, or arteriosclerosis
2. have a pacemaker or an implantable cardioverter defibrillator
3. are currently undergoing treatment for any of the following chronic diseases: liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. are taking medications (including herbal medicines) and supplements
6. are allergic to medications
7. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder, or other issues
8. have irregular sleeping time or habit due to work such as a late-night shift
9. live with their infants less than one year old
10. sleep with their children (1 to 6 years old)
11. live with requiring long-term care persons
12. sleep with more than one person
13. have nocturia three times or more
14. are restricted from daily intense physical activity due to diseases or other reasons
15. use a wearable medical electrical equipment, such as an electrocardiograph
16. need to rest
17. have temperature sensory loss
18. have sleep apnea syndrome
19. are taking antithrombotic medicine or undergoing medical treatment for hematogenous disorder
20. may be jumped on or suddenly touched by people, objects or pets while using the test product
21. cannot use the test product with properly understanding the usage and precautions required to use it
22. are pregnant, lactating, or planning to become pregnant during this study
23. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study
24. are judged as ineligible to participate in this study by the physician
20
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
COSMOHEALTH Co,.Ltd.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
IRB@takara-clinic.com
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
2023 | Year | 12 | Month | 26 | Day |
Unpublished
22
No longer recruiting
2023 | Year | 12 | Month | 13 | Day |
2023 | Year | 12 | Month | 13 | Day |
2023 | Year | 12 | Month | 26 | Day |
2024 | Year | 06 | Month | 17 | Day |
2023 | Year | 12 | Month | 26 | Day |
2024 | Year | 03 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060742
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