Healthy subjects
Conditions
Interventions
Recovery wear (test product) worn from 7 days before the expected start of menstruation until the end of menstruation
Recovery wear(placebo product) worn from 7 days before the expected start of menst
Sponsors
Macromill, Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Women who are between 19 and 40 years of age at the time of obtaining consent to participate in the study (2) Women who experience menstrual pain and take painkillers (3) Subjects with regular menstrual cycles (25 to 38 days) (4) Subjects who are able to agree to the subject management items (5) Subjects who can consent to the use of the results of this study in a form that does not personally identify them for use in academic conferences, corporate advertisements, etc. (6) The applicant must be fully informed of the purpose and content of this study, have the ability to consent, and be able to give his/her consent of his/her own free will after fully understanding the purpose and content of the study, and to give his/her consent by electromagnetic informed consent.
Exclusion criteria
Exclusion criteria: (1) currently receiving or planning treatment for dysmenorrhea, pms, pmdd, menopausal disorders, or other gynecological diseases (2) currently receiving or planning treatment for psychiatric disorders (such as depression, anxiety, insomnia), thyroid disorders (such as graves disease, hashimoto disease), or autonomic nervous system disorders (3) currently receiving or planning treatment for chronic diseases (4) history of serious diseases such as cerebrovascular, cardiac, diabetic, hepatic, renal, gastrointestinal, or vascular disorders (5) pregnant, possibly pregnant, postpartum, or breastfeeding (6) taking oral contraceptives (7) bmi of 25 or more (8) participating in another clinical trial, or having participated or planning to participate within 4 weeks (9) allergy or sensitivity to any component of the study product (10) skin conditions (such as scars, eczema, inflammation, infection, or sunburn) on areas in contact with the product (11) expected major lifestyle changes during the study (such as relocation, job transfer, or long travel) (12) unable to discontinue supplements or herbal remedies for menstrual symptoms (such as magnesium, omega-3, vitamin d) during the study (13) smoking 21 cigarettes or more per day (14) consuming more than 60 grams of alcohol per day on 6 or more days per week (15) extremely irregular eating habits (such as frequently skipping 2 or more meals or eating out almost daily) (16) irregular lifestyle (such as shift work or working late at night) (17) judged unsuitable by the study sponsor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1)Degree of menstrual pain( Numerical Rating Scale:NRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) DRSP Japanese version (2) Dysmenorrhea score (3) Analgesic use or not (4) Short version of DRSP (5) Questionnaire on physical symptoms | — |
Countries
Japan
Contacts
Public ContactYuki Mori
Macromill, Inc. Clinical Research Unit, Life Science Division
Outcome results
None listed