UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055603 |
|---|---|
| Receipt number | R000063539 |
| Scientific Title | Association of menstrual symptoms and capillary image with dietary inflammation and antioxidant indices in young women |
| Date of disclosure of the study information | 2024/09/24 |
| Last modified on | 2025/10/31 12:47:05 |
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Basic information
Public title
Association of menstrual symptoms and capillary image with dietary inflammation and antioxidant indices in young women
Acronym
Association of menstrual symptoms and capillary image with dietary inflammation and antioxidant indices in young women
Scientific Title
Association of menstrual symptoms and capillary image with dietary inflammation and antioxidant indices in young women
Scientific Title:Acronym
Association of menstrual symptoms and capillary image with dietary inflammation and antioxidant indices in young women
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the association of menstrual symptoms and capillary image with dietary inflammation and antioxidant indices in young women
Basic objectives2
Others
Basic objectives -Others
To study the association of menstrual symptoms and capillary image with dietary inflammation and antioxidant indices in young women
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Capillary image
Key secondary outcomes
Total hemoglobin
PSQ score, MDQ score
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 36 | years-old | > |
Gender
Female
Key inclusion criteria
Women between 18 and 35 years old
Those whose menstrual cycle is stable within the normal range (25 to 38 days)
Key exclusion criteria
Those on low-dose pills
Those who are amenorrheic
Those who are pregnant or lactating
Smokers
Those who have difficulty with fingertip measurements
Those who have difficulty completing the survey
Those with illnesses requiring constant medication
Those who regularly use pharmaceuticals, health foods or supplements
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshimi |
| Middle name | |
| Last name | Kishimoto |
Organization
Setsunan University
Division name
Faculty of Agriculture
Zip code
573-0101
Address
45-1, Nagaotoge-cho, Hirakata, Osaka
TEL
0728966352
yoshimi.kishimoto@setsunan.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimi |
| Middle name | |
| Last name | Kishimoto |
Organization
Setsunan University
Division name
Faculty of Agriculture
Zip code
573-0101
Address
45-1, Nagaotoge-cho, Hirakata, Osaka
TEL
0728966352
Homepage URL
yoshimi.kishimoto@setsunan.ac.jp
Sponsor or person
Institute
Setsunan University
Institute
Department
Personal name
Funding Source
Organization
None
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
Setsunan University Ethical Review Committee for Medical and Health Research Involving Human Subjects
Address
17-8, Ikedanaka-machi, Neyagawa, Osaka
Tel
0728001160
setsunan.kenkyu.shakai@josho.ac.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
| 2024 | Year | 09 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Association of menstrual symptoms and capillary image with dietary inflammation and antioxidant indices
Cross-sectional study
Management information
Registered date
| 2024 | Year | 09 | Month | 24 | Day |
Last modified on
| 2025 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063539
