Healthy adult female
Conditions
Interventions
Consumption of study beverage for 3 menstrual cycles
Consumption of control beverage for 3 menstrual cycles
Sponsors
Leverage Brain Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Premenopausal healthy adult females aged 20 to 40 2) Subject whose menstrual cycles, calculated from the last 6 menstrual cycles, are within the range of 25 to 38 days and whose usual menstrual duration is 3 to 7 days. 3) Subject with symptoms of discomfort from about 3 days before the start of menstruation to about the 3rd day of menstruation. 4) Subject who can use electronic diary application (e-DCA) 5) Subject who received sufficient explanation about the purpose and content of the trial, had the ability to consent, volunteered to participate after understanding it well, and agreed to participate in the trial in writing.
Exclusion criteria
Exclusion criteria: 1)Subject who has serious disorders on brain, hepatic, kidney, cardiac, lung, digestive organs, blood, endocrine system, and metabolic system 2)Subject who is under medication on a steady basis or history of medication for serious disorders 3)Subject currently undergoing treatment or with digestive diseases that affect the study or have a surgical history of digestive system(except appendicectomy) 4)Subject with gynecological disorders (secondary amenorrhea, dysmenorrhea, endometriosis, uterine fibroids, premenstrual dysphoric disorder (PMDD), premenstrual syndrome (PMS), breast cancer, cervical cancer, uterine body cancer, ovarian cancer, etc.) 5)Subject who has difficulty drinking study beverage 6)Subject who takes medications and supplements on a daily basis *Except subject who can cancel an intake of health foods and supplements during this trial 7)Subject who has no menstrual discomfort symptoms at all, do not use over-the-counter pain relievers at all when symptoms are present, or whose symptoms are severe and cannot be controlled with over-the-counter pain relievers. 8)Subject who is pregnant, lactating mother, or who is willing to become pregnant during this trial 9)Any candidates considered to be ineligible for enrollment due to the results of health condition questionnaire 10)Subject who took part in the other clinical/monitoring trial within a month before giving informed consent to take part in this trial. 11)Subject with area IV on the Neuroticism Discriminant Chart of the CMI Health Questionnaire 12)Those whose total score on the Postmenstrual Associated Symptom Questionnaire is 0 points or higher than the total score on the Premenstrual Associated Symptom Questionnaire or the total score on the Menstrual Associated Symptom Questionnaire during menstruation, regarding the Menstrual Associated Symptoms Questionnaire (pre-survey). 13)Any candidates considered to be unsuitable for enrollment in the opinion of the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total score of Menstrual Associated Symptoms Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Menstrual Associated Symptoms Questionnaire Physical Symptom Score 2)Menstrual Associated Symptoms Questionnaire Psychological Symptom Score 3)Health Status Questionnaire 4)Sleep-Related Questionnaire 5)Skin and Hair Questionnaire 6)Degree of menstrual pain 7)Basal Body Temperature 8)Hormone Test 9)Skin moisture content, skin oil content | — |
Countries
Japan
Contacts
Public ContactShigeru Imai
Leverage Brain Inc. Clinical Trial Department
Outcome results
None listed