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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029154
Receipt No. R000033334
Scientific Title A randomized parallel trial on the electrostatic therapy equipment along with meals and exercise advice
Date of disclosure of the study information 2017/09/19
Last modified on 2017/12/11

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Basic information
Public title A randomized parallel trial on the electrostatic therapy equipment along with meals and exercise advice
Acronym trial on the electrostatic therapy equipment along with meals and exercise advice
Scientific Title A randomized parallel trial on the electrostatic therapy equipment along with meals and exercise advice
Scientific Title:Acronym trial on the electrostatic therapy equipment along with meals and exercise advice
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of the electrostatic therapy equipment and diet/exercise advice health status for healthy subjects.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Laboratory test results,body weight,blood pressure,body temperature,quality of sleep
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 Electrostatic therapy equipment with diet and exercise advice
Interventions/Control_2 Electrostatic therapy equipment
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Japanese men and woman(age>=20 years when acquiring consent)
2.To participate in this exam for 2 months
3.Not to change diet or exercise therapy during the trial period
4.To comply with informed consent
Key exclusion criteria 1.Medical history of serious renal impairment,cardiovascular disorders,respiratory disorders,endocrine disorders,other serious metabolic disorders.
2.Excessive drinking(20 grams of alcohol a day-eg 500 ml of beer or 1 cup of Japanese sake.)
3.Pregnancy,lactation,and its potential during the trial
4.Those who have participated in other clinical trials within 1 month or those currently participating
5.Those who judge that the client is inappropriate for this trial
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinya Hagiwara
Organization COSMO HEALTH Co.,Ltd.
Division name Sales Department
Zip code
Address 3-108,Yamate,Minokamo,Gifu,Japan
TEL 0120-860-546
Email hagiwara611026@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Mirei Yanase
Organization COSMO HEALTH Co.,Ltd.
Division name Sales Planning Department
Zip code
Address #9F Ueno Bld,2-6-2,Kaji,Ciyoda,Tokyo,Japan
TEL 03-5209-5858
Homepage URL
Email yanase@cosmohealth.co.jp

Sponsor
Institute COSMO HEALTH Co.,Ltd.
Institute
Department

Funding Source
Organization COSMO HEALTH Co.,Ltd.
Organization
Division
Category of Funding Organization Self funding
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 1)電位治療器による治療:コスモヘルス主催の指定会場(岐阜県美濃加茂市山手町3-108)
2)血圧、体重、体温、睡眠時間の測定:被験者のご自宅

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 19 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 Completed
Date of protocol fixation
2017 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 21 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
2017 Year 09 Month 15 Day
Last modified on
2017 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033334

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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