None listed
Conditions
Sponsors
Mediogen
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Females aged 19 to 50 years 2) Participants with a Nugent score of 4 to 6 at Visit 1 3) Participants who voluntarily agree to participate in this human clinical trial and provide written informed consent prior to study initiation
Exclusion criteria
Exclusion criteria: 1) Individuals currently receiving treatment for severe cardiovascular, immune, respiratory, gastrointestinal/hepatic or biliary, renal or urological, neurological, endocrine, psychiatric, infectious diseases, or malignant tumors 2) Individuals using an intrauterine device (IUD) 3) Individuals with current or ongoing treatment for vaginal or urinary tract infections (including candidiasis, trichomoniasis, gonorrhea, chlamydial infection, etc.) 4) Individuals with vaginal bleeding, abnormal vaginal discharge, or abnormalities of the genitourinary system 5) Individuals who have used the following medications within 4 weeks prior to Visit 1: ? Systemic antibiotics, systemic antimicrobial agents, systemic steroids, or systemic immunosuppressants ? Estrogen-containing medications (e.g., oral contraceptives); however, estrogen medications related to menopause are allowed if the dosage and medication have remained unchanged for at least 3 months prior to Visit 1 ? Medications for vaginitis (topical formulations are excluded if used within 2 weeks prior to Visit 1) 6) Individuals who have used the following medications or foods within 2 weeks prior to Visit 1: ? Health functional foods related to immune function improvement or vaginal health ? Intestinal regulators ? Probiotics, prebiotics, or dairy products consumed regularly (=4 days per week) 7) Individuals who have used spermicides, feminine hygiene products, vaginal cleansers, vaginal steam or sitz baths, or received acupuncture therapy for vaginal health within 1 week prior to Visit 1 8) Individuals within 3 days after the end of their last menstrual period as of Visit 1 9) Individuals planning to use a bidet during the study period 10) Excessive smokers (more than 20 cigarettes per day) 11) Individuals consuming alcohol exceeding an average of 20 g per day (140 g per week) 12) Individuals with AST (GOT) or ALT (GPT) levels = 3 times the upper limit of normal at the study site 13) Individuals with thyroid-stimulating hormone (TSH) levels = 0.1 µIU/mL or = 10 µIU/mL 14) Individuals with estimated glomerular filtration rate (eGFR) 140 mmHg or diastolic blood pressure > 90 mmHg, measured after 10 minutes of rest) 16) Individuals with uncontrolled diabetes mellitus (fasting glucose = 126 mg/dL) 17) Pregnant or breastfeeding women, or those planning pregnancy during the study period 18) Individuals who have participated in another interventional clinical trial (including human intervention studies) within 3 months prior to Visit 1, or who plan to participate in another interventional clinical trial during the study period 19) Individuals with known hypersensitivity or allergy to any components of the investigational or placebo product 20) Individuals deemed unsuitable for participation by the investigator for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nugent Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaginal pH;Vaginal microbiota composition;Symptom questionnaire assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactSung Taek Park
Hallym University Medical Center-Kangnam
Outcome results
None listed