2.2. Participants (Subjects)
bleeding, allergic, gastrointestinal tract/liver, vaginal or urinary tract infection, psychiatric
MALIGNANT TUMOR, INFECTIOUS DISEASE, BLEEDING, UNCONTROLLED HYPERTENSION
All subjects (women of reproductive age; 19–50 years) participating in the screening visit were explained the purpose and protocol of this study and the foreseeable risks associated with the trial. Subjects who provided written informed consent to participate in the trial were screened for eligibility by collecting vaginal swabs, blood samples, and medical history and performing a physical examination. Subjects who met the inclusion criteria with a Nugent score of 4–6 were asked to visit within 14 days to enroll in the trial.The exclusion criteria for the protocol were as follows: (1) undergoing treatment for severe cardiovascular system, immune system, respiratory system, gastrointestinal tract/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, psychiatric, infectious disease, and malignant tumor, (2) vaginal or urinary tract infection, bleeding, or abnormality, (3) pregnant or planning pregnancy, (4) breast feeding, (5) using antibiotics, antibacterial agents, steroids, and immunosuppressants, (6) regularly using health functional foods, probiotics, and lactobacillus products, (7) experience of acupuncture treatment for women’s cleanser, vaginal cleanser, sedentary treatment, and vaginal health (within one week of screening visit), (8) uncontrolled hypertension (above 160 mmHg of systolic blood pressure or 100 mmHg of diastolic blood pressure), (9) unregulated diabetics (HbA1C > 6.5%), (10) abnormal creatinine, aspartate aminotransferase or alanine aminotransferase, thyroid stimulating hormone levels, (11) allergic to ingredients of this human-applied test food supplements, and (12) participated in another intervention clinical trial.At the randomization visit (baseline), all subjects who met the inclusion/exclusion criteria were assigned to each group according to 1:1 randomization method. The number of subjects in each group was kept equal for balanced randomization between the intake groups. The randomization table was generated by sequentially applying permutations of random numbers (random numbers A and B) generated by the randomization program of the SAS