UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040559 |
|---|---|
| Receipt number | R000046297 |
| Scientific Title | A study to evaluate the effects of irradiation by test product on the amount of ATP in the body. |
| Date of disclosure of the study information | 2020/05/29 |
| Last modified on | 2024/05/21 14:46:18 |
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Basic information
Public title
A study to evaluate the effects of irradiation by test product on the amount of ATP in the body.
Acronym
A study to evaluate the effects of irradiation by test product on the amount of ATP in the body.
Scientific Title
A study to evaluate the effects of irradiation by test product on the amount of ATP in the body.
Scientific Title:Acronym
A study to evaluate the effects of irradiation by test product on the amount of ATP in the body.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effects of 20 minutes irradiation to be examined on blood ATP(Adenosine TriPhosphate) level in healthy male and female from 20 to 65 years old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adenosine Triphosphate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
20 minutes irradiation to the top of head and lower abdomen.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.20 to 59 years old
2.Healthy Japanese males and females.
3.Those who can provide their written informed consent.
Key exclusion criteria
1.Those who are currently receiving drug treatment of chronic illness.
2.Those who have a current or a past medical history of severe diseases.
3.Those who have a past and current medical history of drug or food allergy.
4.Those who started taking any of the following products in the past three months: drugs, quasi-drug products, and also those who have been routinely taking these products. Those who intend to take these products during the study period.
5.Heavy drinkers.
6.Those who work night shifts.
7.Those who are currently undergoing treatment for drug dependence or drug abuse or those who have a past medical history of either of them.
8.Those who are currently pregnant or breastfeeding or those who want to become pregnant during the study period.
9.Those who are currently participating in another clinical trial or those who took a test product and completed another clinical trial in a month.
10.Those who were determined by the principal investigator and the sub investigator to be unsuitable for participation in this clinical trial.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masumi |
| Middle name | |
| Last name | Mizuno |
Organization
Art of Creation Japan Co., Ltd.
Division name
None
Zip code
171-0021
Address
3-30-10,Nishi-ikebukuro,Toshimaku,Tokyo
TEL
090-6510-7867
mas.mizuno7932@gmail.com
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
IPC Works 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.co.jp
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
| 2020 | Year | 05 | Month | 29 | 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
| 2020 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 28 | Day |
Last modified on
| 2024 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046297
