Tokyo, July 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058569) titled 'A study to verify the alleviation effect on menstrual pain' on July 23.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Maruha Nichiro Corporation

Condition: Condition - Healthy Japanese Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - To verify the effects of consumption of the test product on menstrual pain Basic objectives2 - Efficacy

Intervention: 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

Eligibility: Age-lower limit - 18 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 Size - 69

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066972

Disclaimer: Curated by HT Syndication.