None listed
Conditions
Interventions
Dietary Supplement : Intervention group: CBT VH-Pro probiotics 500mg capsule once a day for 8 weeks
Placebo group: placebo 500mg capsule once a day for 8 week
Sponsors
Cell Biotech
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women of age over 19 years of age and under 60 years of age 2) A person with a score of 4-6 on the Nugent Score. 3) A person who agrees to participate in the human application test before the human application test begins and has prepared the written consent form.
Exclusion criteria
Exclusion criteria: 1) Subjects currently receiving treatment for severe cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary, renal and urinary, neurological, endocrine, psychiatric, or infectious diseases, or malignant tumors. 2) Subjects currently receiving treatment for uterine cancer, ovarian cancer, uterine fibroids, or endometrial polyps (however, those completely cured of cancer for more than 5 years post-treatment may participate at the investigator's discretion). 3) Subjects currently using an intrauterine device. 4) Subjects currently receiving treatment for vaginal infections (Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum, Mycoplasma genitalium, Mycoplasma hominis, Trichomonas vaginalis, Candida albicans), urinary tract infections (candidiasis, trichomoniasis, gonorrhea, chlamydia infection, etc.), dyspareunia, or dysuria. 5) Subjects with vaginal bleeding, abnormal vaginal discharge, or genitourinary abnormalities. 6) Subjects with gastrointestinal bleeding or other bleeding tendencies as determined by the investigator. 7) Subjects with irregular menstrual cycles (menstrual cycle of 45 days or more) due to polycystic ovary syndrome, polymenorrhea, menorrhagia, etc. 8) Subjects whose menstruation started or ended within 1 week prior to Visit 1. 9) Subjects who have used antipsychotic drugs within 3 months (90 days) prior to Visit 1 (however, sleeping pills used for sleep disorders may be permitted for participation and concomitant use at the investigator's discretion). 10) Subjects who have used steroids, hormonal agents, immunosuppressants, estrogen-based drugs (such as oral contraceptives), or vaginitis-related medications within 1 month (30 days) prior to Visit 1. 11) Subjects who have used the following drugs or foods within 4 weeks prior to Visit 1: ? Vaginal health-related dietary supplements (e.g., UREX, Respecta®) ? Probiotics, prebiotics, or lactic acid bacteria products consumed continuously (4 or more days per week). 12) Subjects who have used the following drugs, dietary supplements, or non-pharmacological treatments within 2 weeks prior to Visit 1: ? Topical agents for vaginitis ? Systemic antibiotics ? Systemic antimicrobials or intestinal regulators ? Dietary supplements related to immune function improvement (e.g., red ginseng, Phellinus linteus extract, chlorella, ginseng, alkoxyglycerol-containing shark liver oil, aloe gel, gamma-linolenic acid-containing oils) ? Spermicides, feminine cleansers, vaginal douches, vaginal steaming, or acupuncture for vaginal health. 13) Subjects currently using a bidet or planning to use one during the human application study period (however, participation is possible if the principal investigator medically determines that incidental or single use, such as less than 3 times a week, rather than periodic use during the screening period, does not significantly affect the study results). 14) Heavy smokers (more than 20 cigarettes per day). 15) Subjects with a history of alcohol or drug addiction/abuse. 16) Subjects whose AST (GOT) or ALT (GPT) levels are 3 times or more the upper limit of normal of the testing facility. 17) Subjects whose TSH is = 0.1 µIU/mL = 0.1 µIU/mL or = 10 µIU/mL = 10 µIU/mL. 18) Subjects whose eGFR is 160 mmHg or diastolic blood pressure >100 mmHg, based on measurement after 10 minutes of rest). 20) Subjects with uncontrolled diabetes mell
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nugent Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaginal pH;Vaginal microflora;Symptom Survey Assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung Ju Kim
Ewha Womans University
Outcome results
None listed