Healthy adults
Conditions
Sponsors
Miura Clinic, Medical Corporation Kanonkai
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Subjects of women aged 20 to 49 (2) Subjects with a Nugent score of less than 7 in vaginal microbiota (3) Subjects whose menstrual cycle is around 28 days (4) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
Exclusion criteria
Exclusion criteria: (1) Subjects with bacterial vaginosis and sexually transmitted infections. (2) Subjects with a history of diabetes, liver diseases, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, or other serious disease. (3) Subjects with gynecological diseases (such as endometriosis, uterine fibroids, ovarian cysts, cervical cancer, uterine cancer, etc.) and a history of such conditions. (4) Subjects who have undergone gastrointestinal surgery (5) Subjects with abnormal liver and renal function test values (6) Subjects with diseases currently being treated (7) Subjects who are allergic to food and drugs (8) Female subjects wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects (9) Subjects who play intense sports and subjects who are on a diet (10) Subjects with extremely irregular eating habits s (11) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period (12) Subjects using products or drugs that affect hormone balance (13) Subjects receiving antibiotics (14) Subjects who are continuously treated with pharmaceuticals (including OTC and prescription drugs) (15) Subjects who drink more than 40 g of pure alcohol per day (16) Subjects who cannot abstain from alcohol from the day before the test to the day of the test (17) Subjects who smoke an average of more than 21 cigarettes per day. (18) Subjects who are participating in or will participate in other clinical trials at the start of this study (19) Other subjects judged by the investigator or the investigator to be inappropriate for the examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nugent score Visual Analogue Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety (adverse events, body measurements, physical examinations, clinical tests) | — |
Countries
Japan
Contacts
Public ContactMakoto Terashima
Oneness Support Co., Ltd. Crinical Trial Division
Outcome results
None listed