UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055000 |
|---|---|
| Receipt number | R000062837 |
| Scientific Title | Comprehensive Analysis of Factors Improving Premenstrual Syndrome by Intake of Oligonol (low molecular weight polyphenol) - Double-blind, placebo-controlled RCT study in young women |
| Date of disclosure of the study information | 2024/07/17 |
| Last modified on | 2024/07/17 18:38:01 |
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Basic information
Public title
Comprehensive Analysis of Factors Improving Premenstrual Syndrome by Intake of Oligonol (low molecular weight polyphenol) - Double-blind, placebo-controlled RCT study in young women
Acronym
Comprehensive Analysis of Factors Improving Premenstrual Syndrome by Intake of Oligonol (low molecular weight polyphenol) - Double-blind, placebo-controlled RCT study in young women
Scientific Title
Comprehensive Analysis of Factors Improving Premenstrual Syndrome by Intake of Oligonol (low molecular weight polyphenol) - Double-blind, placebo-controlled RCT study in young women
Scientific Title:Acronym
Comprehensive Analysis of Factors Improving Premenstrual Syndrome by Intake of Oligonol (low molecular weight polyphenol) - Double-blind, placebo-controlled RCT study in young women
Region
| Japan |
Condition
Condition
premenstrual syndrome(PMS)
Classification by specialty
| Obstetrics and Gynecology | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to comprehensively analyze factors related to menstrual symptoms caused by the intake of Oligonol (low molecular weight polyphenol) by metabolomic analysis, and to elucidate the mechanism of improvement of menstrual symptoms by Oligonol, which has strong antioxidant effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjects will be asked to take the sample once a day for 8 weeks, one capsule (200 mg per capsule) before sleep. The sample will be taken starting on the 21st day after the start of the last menstrual period (day 0) and will be taken until the 21st day after the start of menstruation 2 months later (day 56). Urine samples will be sent to Human Metabolome Technologies, Inc. for metabolomics analysis using a cohort study pack (CE-FTMS).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects will be asked to take the sample once a day for 8 weeks, one capsule (200 mg per capsule) before sleep. The sample will be taken starting on the 21st day after the start of the last menstrual period (day 0) and will be taken until the 21st day after the start of menstruation 2 months later (day 56).
Interventions/Control_2
Test sample: (1) Oligonol: 1 capsule (200 mg) (2) Placebo (dextrin): 1 capsule (200 mg)
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
| 25 | years-old | > |
Gender
Female
Key inclusion criteria
Normal menstruation
Key exclusion criteria
Menstrual irregularities, pill users, and users of antioxidant supplements different from those in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Taga |
Organization
Wayo Women's University
Division name
Department of Health and Nutrition, Faculty of Home Economics
Zip code
2728533
Address
2-3-1 Konodai, Ichikawa-shi, Chiba
TEL
047-371-1591
m-taga@wayo.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Taga |
Organization
Wayo Women's University
Division name
Department of Health and Nutrition, Faculty of Home Economics
Zip code
2728533
Address
2-3-1 Konodai, Ichikawa-shi, Chiba
TEL
047-371-1591
Homepage URL
m-taga@wayo.ac.jp
Sponsor or person
Institute
Wayo Women's University
Institute
Department
Personal name
Funding Source
Organization
Amino Up Corp
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wayo Women's University
Address
2-3-1 Konodai, Ichikawa-shi, Chiba
Tel
047-371-1591
m-taga@wayo.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 | 07 | Month | 17 | 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
20
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 | 05 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 17 | Day |
Last modified on
| 2024 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062837
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| Registered date | File name |
| Research case data | |
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