Healthy Japanese subjects
Conditions
Interventions
Participants will take the test food, starting from day 8 of menstruation and continuing until the final visit after three menstrual cycles.
Participants will take the placebo food, starting from day
Sponsors
ROHTO PHARMACEUTICAL CO., LTD.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese adult women 2. Experience discomfort such as menstrual pain during menstruation 3. Regular menstrual cycles (25-38 days) and periods lasting 3-7 days 4. Able to enter electronic diaries via smartphone or PC 5. Fully informed about the study and voluntarily consented in writing
Exclusion criteria
Exclusion criteria: 1. Currently receiving treatment for any illness with medication or Kampo (as-needed use permitted) 2. Under dietary or exercise therapy supervised by a physician 3. Current or past gynecological disorders that may affect the study 4. Total score of 13 or higher on the questionnaire on menstrual symptoms with menstrual pain as the main complaint 5. Used oral contraceptives within 6 months before consent or plans to use during the study 6. Postmenopausal 7. Current or past organic gastrointestinal diseases (excluding appendicitis and hemorrhoids) 8. Current or past serious liver, kidney, heart, respiratory, endocrine, or metabolic diseases 9. Regular use of over-the-counter drugs, quasi-drugs, specified health foods, health foods, or supplements (eligible if discontinued after consent and during the study) 10. Possible allergy to the test food 11. Shift workers with night shifts 12. Plans to significantly change lifestyle (diet, sleep, exercise, etc.) during the study 13. Plans for overseas travel during the study 14. Habitual excessive alcohol consumption (>=40g/day) 15. Excessive smoking 16. Currently pregnant, breastfeeding, wishing to become pregnant during the study, or possibly pregnant 17. Participation in another clinical study within 3 months before consent, currently participating, or planning to participate during the study 18. Deemed unsuitable for the study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -NRS score for menstrual pain | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: -Menstrual Distress Questionnaire (MDQ) during menstruation -WPAI-GH Safety outcomes: Incidence of adverse events and side effects Other outcomes: Background survey, medical interview, questionnaire on menstrual symptoms with menstrual pain as the main complaint, physical measurements, physiological tests, blood tests, transvaginal ultrasound examination, lifestyle survey | — |
Countries
Japan
Contacts
Public ContactHirokuni Kayama
IMEQRD Co., Ltd. Planning and Sales Department
Outcome results
None listed