UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029154 |
|---|---|
| Receipt number | 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 11:16:15 |
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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
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
yanase@cosmohealth.co.jp
Sponsor or person
Institute
COSMO HEALTH Co.,Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033334
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
