UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039171 |
|---|---|
| Receipt number | R000044674 |
| Scientific Title | A study for effects of menstrual cycle of quantities of biogas from women's skin surface, an open trial. |
| Date of disclosure of the study information | 2021/07/31 |
| Last modified on | 2023/10/05 13:42:38 |
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Basic information
Public title
A study for effects of menstrual cycle on quantities of biogas from skin surface in young women, an open trial.
Acronym
A study for effects of menstrual cycle of quantities of biogas from women's skin surface.
Scientific Title
A study for effects of menstrual cycle of quantities of biogas from women's skin surface, an open trial.
Scientific Title:Acronym
A study for effects of menstrual cycle of quantities of biogas from women's skin surface.
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identification of the biogas depending on the menstrual cycle from skin surface.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of the biogas depending on the menstrual cycle from skin surface using GC-MS.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
1) Females aged from 20 to less than 30 years old, when giving the informed consent.
2) Females with consistent severity of symptoms of premenstrual syndrome (PMS).
3) Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will.
Key exclusion criteria
1) Individuals who receives medications or functional foods affecting on the female hormone.
2) Individuals whose menstrual cycle is more than 18 days, less than 45 days, or extremely fluctuating.
3) Individuals who are pregnant, planning to be pregnant, or breastfeeding during the test period.
4) Individuals who are or have been serious metabolic disease, including diabetes, thyroid disease, and adrenal disease.
5) Individuals whose body mass index (BMI) is lower than 18.5 kg/m-2, or higher than 32 kg/m-2.
6) Individuals who are drug fiend or alcoholic. Individuals who have a history of drug fiend or alcoholic.
7) Individuals who have smoking habitat.
8) Individuals who are going to be abroad for a long period and are difficult to participate to the study for at least one menstrual cycle.
9) Individuals who are participating or willing to participate in another clinical trial with intervention of foods, medications, and cosmetics.
10) Individuals who work for the company developing, producing, or selling functional foods.
11) Individuals who are judged unsuitable for this study by the investigator for other reasons.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Morimoto |
Organization
Nara Women's University
Division name
Faculty of Human Life and Environmental Health
Zip code
630-8506
Address
Kita-Uoya Nishi-machi, Nara-shi Nara, 630-8506, Japan
TEL
0742-20-3965
kmorimot@cc.nara-wu.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Morimoto |
Organization
Nara Women's University
Division name
Faculty of Human Life and Environmental Health
Zip code
630-8506
Address
Kita-Uoya Nishi-machi, Nara-shi Nara, 630-8506, Japan
TEL
0742-20-3965
Homepage URL
kmorimot@cc.nara-wu.ac.jp
Sponsor or person
Institute
Nara Women's University
Institute
Department
Personal name
Funding Source
Organization
Kirin holdings 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
The Nara Women's University Human Research Ethics Comittee
Address
Kita-Uoya Higashi-machi, Nara, 6308506, Japan
Tel
0742-20-3338
kenkyou@cc.nara-wu.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
| 2021 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.cell.com/heliyon/pdf/S2405-8440(23)06835-4.pdf
Number of participants that the trial has enrolled
14
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
| 2019 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective study to identify biogas associated with the menstrual cycle.
Management information
Registered date
| 2020 | Year | 01 | Month | 16 | Day |
Last modified on
| 2023 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044674
