UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035978 |
|---|---|
| Receipt number | R000040973 |
| 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 | 2019/02/22 18:17:09 |
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Basic information
Public title
Effect of Sasa powder intake or/and a 60 Hz electric field treatment on sleep quality.
Acronym
Effect of Sasa powder intake or/and a 60 Hz electric field treatment on sleep quality.
Scientific Title
Effect of Sasa powder intake or/and a 60 Hz electric field treatment on sleep quality.
Scientific Title:Acronym
Effect of Sasa powder intake or/and a 60 Hz electric field treatment on sleep quality.
Region
| Japan |
Condition
Condition
healthy humans
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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 .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain waves during sleep
Key secondary outcomes
OSA sleep inventory MA version
Visual Analogue Scale
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Oral ingestion of the test food once a day for 4 weeks
Electric potential therapy equipment used for 4 weeks during sleep
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
| 40 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Female
Key inclusion criteria
(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
Key exclusion criteria
(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
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal Medicine
Zip code
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL
0661355200
mterashima@oneness-sup.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical Trial Division
Zip code
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL
0648018917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
Hakuju Institute for Health Science Co.,Ltd.
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
Address
Tel
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
| 2019 | Year | 02 | Month | 22 | 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
| 2019 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 22 | Day |
Last modified on
| 2019 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040973
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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