Unique ID issued by UMIN | UMIN000035977 |
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Receipt number | R000040964 |
Scientific Title | Effect of Sasa powder intake or/and a 60 Hz electric field treatment on sleep quality. |
Date of disclosure of the study information | 2019/02/22 |
Last modified on | 2019/08/07 09:24:24 |
Effect of Sasa powder intake or/and a 60 Hz electric field treatment on sleep quality.
Effect of Sasa powder intake or/and a 60 Hz electric field treatment on sleep quality.
Effect of Sasa powder intake or/and a 60 Hz electric field treatment on sleep quality.
Effect of Sasa powder intake or/and a 60 Hz electric field treatment on sleep quality.
Japan |
healthy humans
Adult |
Others
NO
Subject to ingest Sasa powder the people who are feeling the lack of sleep, also by comparing the brain waves and subjective symptoms during sleep when were treated with combination a 60 Hz electric field the household potential therapeutic instrument, effect on the improvement of the quality of sleep .
Efficacy
Brain waves during sleep
OSA sleep inventory MA version
Visual Analogue Scale
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Oral ingestion of the test food once a day for 4 weeks
Oral ingestion of the placebo control food once a day for 4 weeks
40 | years-old | <= |
64 | years-old | >= |
Female
(1) 40<=Age<64 of healty men and women
(2) Subjects in menopause
(3) Subjects with reduced sleep quality
(4) Subjects not taking drugs such as sleeping pills
(5) Subjects who received a sufficient explanation of the purpose and details of the examination, voluntarily participate in voluntary participation after having a good understanding, understanding well and agreeing to participate in the examination in writing
(1) Subjects with diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disease, or medical history for severe diseases
(2) Subjects who are diagnosed with heart disease and are restricted from daily extreme exercise
(3) Subjects using implantable medical electrical devices (pacemakers, implantable defibrillators, etc.) that are susceptible to electromagnetic interference
(4) Subjects using wearable medical electrical devices (electrocardiographs, pacemakers, etc.)
(5) Subjects who indicate abnormal parameter in liver or kidney function
(6) Subjects with a disease under treatment now
(7) Subjects with drug or food allergy
(8) Subjects who play high intensity sports or are on a diet
(9) Subjects who can not stop taking health foods (including food for specified health uses, foods with function claimss) or designated quasi drugs during the examination period
(10) Subjects taking continuous medication (including OTC, prescription drugs)
(11) Subjects taking health foods, quasi-drugs, medicines (including OTC, prescription medicine) expected to improve insomnia
(12) Subjects using sleep-promoting bedding / equipment
(13) Subjects who have used Healthtron or other electric potential therapy devices at present or in the past
(14) Subjects who consume excess alcohol or who can not abstain from the day before the test to the day during the sleep brain wave measurement period
(15) Subject who has been pregnant or subject who have a plan to become pregnant or breast feed during the study period
(16) Subjects who is participating in the other study or planning to participate during the study period
(17) Subjects deemed unsuitable by the investigator for other reasons
12
1st name | Naoki |
Middle name | |
Last name | Miura |
Miura Clinic, Medical Corporation Kanonkai
Internal Medicine
5300044
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
0661355200
info@miura-cl.jp
1st name | Makoto |
Middle name | |
Last name | Terashima |
Oneness Support Co., Ltd.
Clinical Trial Division
5300044
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
0648018917
mterashima@oneness-sup.co.jp
Miura Clinic, Medical Corporation Kanonkai
Hakuju Institute for Health Science Co.,Ltd.
Profit organization
Miura Clinic, Medical Corporation Kanonkai IRB
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
0661355200
mterashima@oneness-sup.co.jp
NO
医療法人花音会みうらクリニック(大阪府) Miura Clinic, Medical Corporation Kanonkai(Osaka)
2019 | Year | 02 | Month | 22 | Day |
Unpublished
15
Completed
2019 | Year | 02 | Month | 21 | Day |
2019 | Year | 02 | Month | 22 | Day |
2019 | Year | 02 | Month | 25 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 02 | Month | 22 | Day |
2019 | Year | 08 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040964
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