UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058569 |
|---|---|
| Receipt number | R000066972 |
| Scientific Title | A study to verify the alleviation effect on menstrual pain: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2026/07/23 |
| Last modified on | 2025/11/06 12:05:47 |
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Basic information
Public title
A study to verify the alleviation effect on menstrual pain
Acronym
A study to verify the alleviation effect on menstrual pain
Scientific Title
A study to verify the alleviation effect on menstrual pain: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
A study to verify the alleviation effect on menstrual pain
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To verify the effects of consumption of the test product on menstrual pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Japanese version of Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2)
Key secondary outcomes
1. Frequency of analgesic doses, fatty acid composition, and other parameters
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: Approximately five months (four cycles of menstruation: 100~160 days)
Test product: Fish sausage containing high-dose purified fish oil
Interventions/Control_2
Duration: Approximately five months (four cycles of menstruation: 100~160 days)
Test product: Fish sausage containing purified fish oil
Interventions/Control_3
Duration: Approximately five months (four cycles of menstruation: 100~160 days)
Test product: Fish sausage containing palm oil
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
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Japanese
2. Women
3. Individuals aged between 18 and 29 years
4. Healthy individuals
5. Individuals whose last two menstrual cycles were between 25 and 32 days
6. Individuals whose Numerical Rating Scale (NRS) is four or more at screening
7. Individuals who take painkillers or pills for menstrual pain at their own discretion*
*This excludes those instructed by a physician to take them for the treatment of a disease. It also excludes those taking them for purposes other than menstrual pain.
Key exclusion criteria
Individuals who
1. are undergoing treatment or have a history of malignant tumor, heart failure, or myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator
3. are undergoing treatment for cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. are taking or using medicines (including herbal medicines) or supplements for purposes other than the treatment or alleviation of menstrual pain or menstrual complaints
6. are allergic to medicines or foods related to the test product (seafood, wheat, soybeans, or gelatin)
7. consume fish (e.g., blue-backed fish such as mackerel, sardines, or horse mackerel; tuna; skipjack; cod; or salmon) four or more times per week, or may significantly change the frequency or amount of fish intake during this study
8. have a history of positive or false-positive tumor markers (e.g., CA125 or CA19-9) during health examinations or others
9. are judged as ineligible to participate in this study because their CA125 exceeded 35 U/mL or CA19-9 exceeded 37 U/mL at the 0-cycle menstrual examination
10. may undergo treatment involving bleeding (e.g., surgery or tooth extraction) during this study or within two weeks after the end of the intervention
11. have been diagnosed with or have a history of premenstrual dysphoric disorder (PMDD), or meet the diagnostic criteria in the "Guidelines for Obstetrics and Gynecology Practice -Gynecology Outpatient 2023"
12. are pregnant, lactating, or planning to become pregnant during this study
13. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
14. are judged as ineligible to participate in this study by the physician
Target sample size
69
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
Maruha Nichiro Corporation
Institute
Department
Personal name
Funding Source
Organization
Maruha Nichiro Corporation
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 ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 23 | 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
78
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
| 2025 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 23 | Day |
Last modified on
| 2025 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066972
