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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035978
Receipt No. 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

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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
Email 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
Email mterashima@oneness-sup.co.jp

Sponsor
Institute Miura Clinic, Medical Corporation Kanonkai
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040973

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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