Healthy adults
Conditions
Interventions
Take one capsule of test food after breakfast once a day for 12 weeks.
Take one capsule of placebo food after breakfast once a day for 12 weeks.
Sponsors
IMEQRD Co., Ltd
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged between 20 and less than 40 years old. 2. Japanese females. 3. BMI is less than 30.0 kg/m2. 4. Individuals whose menstruation cycle is stable for recent 3 months (21-35 days cycle, 3-7 days menstruation period). 5. Individuals who have any psychological or physical discomfort during pre-menstruation and menstruation. 6. Individuals who can use smartphones or PCs to input an electronic diary. 7. Individuals who received sufficient explanation for the objective and summary of the trial, and voluntarily volunteered to the trial with the agreement of informed consent.
Exclusion criteria
Exclusion criteria: 1. Individuals who are currently undergoing treatment for any disease or receive medical treatment such as medical drugs or traditional Chinese medicines. Medications used as needed including antipyretic analgesic are acceptable. 2. Individuals who have received any endocrine therapy in past 3 months. 3. Individuals who have been diagnosed as PMDD, or have symptoms of PMDD. 4. Individuals who are receiving nutritional and exercise therapy by medical doctors. 5. Individuals who have any severe disease or any severe symptoms, or history of severe diseases. 6. Individuals who have any digestive disease, or history of any digestive diseases, except appendicitis. 7. Individuals who have taken foods or used products including pycnogenol. 8. Individuals who have any psychologically stressful events, including death of whose relatives or friends, whose or whose parents' divorce, financial hardship, or accident, in past 3 months. 9. Individuals who have regularly been taking commercially available drugs, quasi-drug products, foods, or supplements with any functional claims. 10. Individuals who have allergies to drugs or foods. 11. Individuals who are planning extremely change lifestyle (such as diet, sleep, or exercise) during the study. 12. Individuals who are planning travel to foreign countries during the study period. 13. Currently pregnant or breastfeeding, or planning to pregnant during the study. 14. Individuals who donated blood more than 400 mL in past 3 months or 200 mL in past one month before screening date. 15. Shift workers. 16. Taking more than 60 g alcohol/day. 17. Individuals who joined other clinical trials from one month before the trial, individuals who have currently been joined other clinical trials, and also Individuals who are planning to join other clinical trials during the study. 18. Individuals who are unsuitable for the study, that judged by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSQ, Premenstrual Symptoms Questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| MDQ, Menstrual Distress Questionnaire. | — |
Countries
Japan
Contacts
Public ContactYoshitada Hira
IMEQRD Co., Ltd Planning and Sales Department
Outcome results
None listed