Healthy volunteers
Conditions
Interventions
Intake of test food for 3 menstrual cycles (11-13 weeks)
Intake of placebo for 3 menstrual cycles (11-13 weeks)
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy adult females whose age of 25 years or more and less than 40 years (at the time of informed consent) 2. Subjects with 25 to 38 days menstrual cycle in the latest 6 menstruations and the menstrual duration is 3 to 7 days 3. Subjects with some menstrual symptoms before and during menstruation 4. Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the present study and being able to sign a written informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects who are pregnant or lactating, or intending to become pregnant during the study 2. Subjects who have histories of gynecologic disorder or have gynecologic disorder 3. Subjects with food allergies 4. Subjects who have diarrhea by intake of dairy products 5. Subjects who take regularly pharmaceuticals (including Chinese medicine and pill) or supplements which have the possibility to affect the results of the present study from 2 months before the time of informed consent to the day of informed consent 6. Subjects who take foods or drinks containing lactic acid bacteria (e.g. yoghurt) which have the possibility to affect the results of the present study 4 days or more a week 7. Subjects who had participated in other pharmaceutical or food clinical studies from 1 month before the time of informed consent to the day of informed consent 8. Subjects who often take analgesics for prophylactic purposes before having menstrual pain 9. Subjects whose MDQ score after menstruation is 1 or more points higher compared to the score of before or during menstruation at the first screening 10. Subjects with severe menstrual symptoms unable to be controlled by OTC analgesics 11. Subjects classified as psychosomatic (Type IV) by CMI health questionnaire 12. Subjects with a score of 20 or more for the stress score by Stress Check List 13. Subjects deemed unsuitable for the present study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MDQ (Menstrual Distress Questionnaire) score | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS (Visual Analogue Scale) SF-36 (Medical Outcomes Study 36-Item Short-Form Health Survey) score Number of analgesic use | — |
Countries
Japan
Contacts
Public ContactTomohiro Sugino
Soiken Inc. R&D Division
Outcome results
None listed