Study on the effect of continuous intake of test foods on physical and psychological discomfort concerning menstruation -double-blind, parallel-group comparison trial
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000048186
- Lead Sponsor
- IMEQRD Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 110
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method