UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049552 |
|---|---|
| Receipt number | R000056431 |
| Scientific Title | Observational study of the associations between Premenstrual Syndrome (PMS) and blood compositions |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2024/05/20 12:41:21 |
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Basic information
Public title
Observational study of the associations between Premenstrual Syndrome (PMS) and blood compositions
Acronym
Study of associations between Premenstrual Syndrome (PMS) and blood compositions
Scientific Title
Observational study of the associations between Premenstrual Syndrome (PMS) and blood compositions
Scientific Title:Acronym
Study of associations between Premenstrual Syndrome (PMS) and blood compositions
Region
| Japan |
Condition
Condition
Premenstrual Syndrome
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify associations between PMS and blood compositions
Basic objectives2
Others
Basic objectives -Others
Associations between PMS and blood compositions
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Associations between PMS and blood compositions
Key secondary outcomes
1)Associations between PMS and lifestyle habits
2)Associations between PMS and background information
3)Associations between PMS and intakes
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
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Females aged 18-39 years at the time of informed consent
2)Subjects with BMI 18.5 to 25 kg/m2
3)Subjects who have a stable menstrual cycle within the normal range (25 to 38 days)
4)Subjects who can input electronic diaries using PCs, smartphones, etc
5)Subjects who have received a sufficient explanation of the purpose and contents of the examination, can consent, have well understood, volunteered to participate, and have signed the informed consent document
Key exclusion criteria
1)Subjects who are currently pregnant or breastfeeding, and subjects who wish to become pregnant during the study period
2)Subjects taking hormonal contraceptives (including low-dose pills)
3)smoker
4)Subjects with a history of and presenting psychiatric illness
5)Subjects with surgical injuries or medical conditions that may affect study conduct
6)Subjects with iron deficiency anemia (hemoglobin <11.5g / dl)
7)Subjects who plan to change their lifestyle (eating, sleeping, exercise habits, etc.) significantly during the test period, such as long-term travel
8)Subjects who have collected more than 200 ml of blood within 12 weeks before the start of the study
9)Subjects who are judged to be inappropriate by the principal investigator
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | Yoji |
| Middle name | |
| Last name | Yamada |
Organization
AJINOMOTO CO., INC.
Division name
Institute of Food Sciences and Technologies
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
TEL
+81-44-210-5844
youji.yamada.wn9@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Aachi |
Organization
AJINOMOTO CO., INC.
Division name
Institute of Food Sciences and Technologies
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
TEL
+81-44-210-5844
Homepage URL
yusuke.adachi85.6jg@asv.ajinomoto.com
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
AJINOMOTO CO., INC.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Human Metabolome Technologies, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14 takadanobaba, sinjuku-ku, Tokyo, Japan
Tel
+81-3-6704-5968
clinical-trial@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
医療法人社団 浩央会 東小金井さくらクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | 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
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment period: December 1 in 2022 to January 1 in 2023
Management information
Registered date
| 2022 | Year | 11 | Month | 18 | Day |
Last modified on
| 2024 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056431
