Healthy Japanese
Conditions
Interventions
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association Minami-machi Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Women 3. Adults 4. Healthy individuals 5. Individuals who are concerned about their vaginal odor 6. Individuals whose Nugent Score is high
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are diagnosed with bacterial vaginosis, cervical cancer, or sexually transmitted disease 5. Individuals who have a medical history of toxic shock syndrome 6. Individuals who cannot collect vaginal secretions according to the established procedure with a dedicated kit 7. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 8. Individuals who are taking or using medications (including herbal medicines) or supplements 9. Individuals who are allergic to medicines or foods related to the test products 10. Individuals who are pregnant, lactating, or planning to become pregnant during this study, or who are using spermicides as a method of contraception 11. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 12. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of Nugent Score at 8 weeks after intervention (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of vaginal refreshing feeling, vaginal dry feeling, vaginal itchiness, vaginal uncomfortable feeling, vulvar dry feeling, vulvar itchiness, vulvar uncomfortable feeling, amount of vaginal discharge, menstrual blood loss volume, menstrual pain, menstrual hardship, and pain during sexual intercourse at 8w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed