Healthy people
Conditions
Interventions
1) Ingestion of study food substance: from 8th day of last menstruation started to 4th day of second menstruation started 2) Break period :from 5th day of second menstruation started to 7th day of th
Sponsors
Leverage Brain Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Subjects who received adequate explanation of the purpose and contents of this clinical trial volunteered with sufficient consent, voluntarily volunteered with voluntary understanding, agreed to participate in the document. 2) Subjects who are healthy female between 25 and 40 years old at the point of obtaining informed consent. 3) Subjects with 25 to 38 days menstrual cycle in the latest 6 menses and the menstrual duration is 3 to 7 days. 4) Subjects with menstrual symptoms from 3th day before menstruation strated to 3th day of menstruation strated.
Exclusion criteria
Exclusion criteria: 1) Pregnant, lactating women or willing to be pregnancy during the study 2) Subjects who are willing to become pregnant during this study 3) Subjects who have histories of gynecologic disorder or have gynecologic disorder * Gynecologic disorder: Secondary amenorrhea, Dysmenorrhea, Endometriosis, Fibroid, Premenstrual dysphoric disorder (PMDD , Breast cancer, Cervical cancer, Uterine body cancer, Ovary cancer etc. 4) Subject with allergy to milk, wheat, egg, shrimp, crab, or subjects with lactose intolerance 5) Subjects who had participated in other clinical trials or monitoring studies within 2 month prior to obtaining informed consent 6) Subjects without menstruation pain, or subjects with severe menstruation pain and unable to control the pain by taking over-the-counter analgesic medication 7) Subjects classified as psychosomatic (Type IV) by CMI health questionnaire 8) Subjects with a score of 20 and above for the stress score by Brief Stress Level Check List 9) Subjects whose total score of menstrual symptoms survey items at the point of postmenstrual period is 1 or more points higher compared to the total score of the survey items before a menstrual period begins or during menstrual period in menstrual symptoms survey items (preliminary survey) 10) Subject who is ineligible for this study due to medical doctor's judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total score of menstrual symptoms survey items | — |
Secondary
| Measure | Time frame |
|---|---|
| - Physical symptom score of menstrual symptoms survey items - Psychological symptoms score of menstrual symptoms survey items - VAS for menstrual pain | — |
Countries
Japan
Contacts
Public ContactShigeru Imai
Leverage Brain Inc. Clinical Trial Department
Outcome results
None listed