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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041271
Receipt No. R000047134
Scientific Title A study to evaluate the effects of irradiation by test product on amount of ATP in the body Part2
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/31

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Basic information
Public title A study to evaluate the effects of irradiation by test product on amount of ATP in the body Part2
Acronym A study to evaluate the effects of irradiation by test product on amount of ATP in the body Part2
Scientific Title A study to evaluate the effects of irradiation by test product on amount of ATP in the body Part2
Scientific Title:Acronym A study to evaluate the effects of irradiation by test product on amount of ATP in the body Part2
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 60 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
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 Treatment
Type of intervention
Other
Interventions/Control_1 60 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
65 years-old >
Gender Male and Female
Key inclusion criteria 1. 20 to 64 years old
2. Healthy Japanese males and females.
3. Those who take breakfast, lunch and dinner everyday.
4. 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.Smoker
7.Those who work night shifts.
8.Those who are currently undergoing treatment for drug dependence or drug abuse or those who have a past medical history of either of them.
9.Those who are currently pregnant or breastfeeding or those who want to become pregnant during the study period.
10.Those who are currently participating in another clinical trial or those who took a test product and completed another clinical trial in a month.
11.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 3-3-10, Nishi-ikebukuro, Toshimaku,Tokyo, Japan
TEL 090-6510-7867
Email Mas.mizuno7932@gmail.com

Public contact
Name of contact person
1st name Yoshitada
Middle name
Last name Hira
Organization imeQ RD inc.
Division name Sales department
Zip code 104-0061
Address 6-2-1 Ginza Chuo-ku Tokyo Japan
TEL 03-6704-5968
Homepage URL
Email y-hira@imeqrd.co.jp

Sponsor
Institute imeQ RD inc.
Institute
Department

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
Email suda-clinic_irb@imeq.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 08 Month 01 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
2020 Year 07 Month 17 Day
Date of IRB
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2020 Year 08 Month 01 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 07 Month 31 Day
Last modified on
2020 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047134

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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