UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045066 |
|---|---|
| Receipt number | R000051485 |
| Scientific Title | Survey on physical and mental discomfort after taking monitor food on people with weather pain. |
| Date of disclosure of the study information | 2021/08/16 |
| Last modified on | 2022/02/02 09:17:11 |
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Basic information
Public title
Survey on physical and mental discomfort after taking monitor food on people with weather pain.
Acronym
Survey on physical and mental discomfort after taking monitor food on people with weather pain.
Scientific Title
Survey on physical and mental discomfort after taking monitor food on people with weather pain.
Scientific Title:Acronym
Survey on physical and mental discomfort after taking monitor food on people with weather pain.
Region
| Japan |
Condition
Condition
People with weather pain
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effects of the monitor food on the frequency, degree, duration, and degree of improvement of physical and mental disorders that are perceived to be related to weather conditions in people with weather pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency, severity, duration, and degree of improvement of physical and mental disorders perceived to be related to weather conditions.
Key secondary outcomes
Frequency of adverse events
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
| Food |
Interventions/Control_1
28 days intake of monitor food
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Subjects who have given consent to participate in the survey (adult males and females).
2)Subjects with weather pain who have moderate headaches.
3)Subjects who are able to consume monitor food according to the schedule instructed by the researcher.
4)Subjects who can submit the results of medical examinations, if necessary.
Key exclusion criteria
1)Subjects who have food allergies.
2)Subjects who are pregnant, lactating, or who wish to become pregnant during the study period.
3)Subjects who are estimated inappropriate to this survey by principal investigator and investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasutaka |
| Middle name | |
| Last name | Ikeda |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho Kanzakigun, Saga
TEL
0952-52-1522
Ikeda.Yasutaka@otsuka.jp
Public contact
Name of contact person
| 1st name | Tsubasa |
| Middle name | |
| Last name | Mizokami |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho Kanzakigun, Saga
TEL
0952-52-1522
Homepage URL
Mizokami.Tsubasa@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical 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
Otsuka Pharmaceutical Co., Ltd.
Address
Shinagawa Grand Central Tower, 2-16-4, Konan, Minato-ku, Tokyo
Tel
03-6717-1499
shimizu_se@otsuka.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
| 2021 | Year | 08 | Month | 16 | 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
458
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
| 2021 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 04 | Day |
Last modified on
| 2022 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051485
