Bacterial vaginitis
Conditions
Interventions
Experimental group 1:Baofukang suppository, high dose
Experimental group 2:Baofukang suppository, low dose
Control Group 2:Metronidazole vaginal gel
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1) Sexually active females aged 18-50 years (including cut-off values); (2) Meets the diagnosis of bacterial vaginosis (BV): Amsel criteria: It is the clinical "gold standard" for the diagnosis of bacterial vaginosis. A positive clue cell must be required, and 2 of the other 3 items are sufficient. ? Positive clue cells (i.e., the number of clue cells >20% of the total number of vaginal epithelial cells); ? positive amine test; ?Vaginal discharge pH > 4.5; ?Vaginal discharge was homogeneous, thin, and off-white. (3) Nugent score =7; (4) Informed consent and voluntary participation in this study, and signed the informed consent form; (5) Those who have regular menstruation and are > 7 days before the next menstrual period.
Exclusion criteria
Exclusion criteria: (1) Known to have other infections (non-BV) that cause any vaginitis other than BV (such as trichomoniasis vaginitis, vulvovaginal candidiasis, aerobic bacterial infection, chlamydia infection, gonorrhea, genital herpes, genital warts, etc.); (2) Those who have a history of vaginal topical medication within 7 days before enrollment or are using related treatments or vaginal lavage; (3) Patients treated with systemic antibiotics within 14 days prior to enrollment; (4) Pregnant and lactating women or those who plan to become pregnant in the near future; (5) Patients with serious primary diseases such as heart, brain, liver, kidney, blood system and endocrine system; (6) Known patients with pelvic inflammatory disease, cervicitis and acute infection of the genitourinary system; (7) Have a history of malignant tumors before screening and the investigator believes that it is not suitable for inclusion; (8) Patients with abnormal vaginal bleeding for any reason or known clinical symptoms caused by uterine fibroids, adenomyosis, endometrial hyperplasia, etc., and the investigator believes that intervention and treatment are required; (9) Cervical lesions that require intervention and treatment or are being treated; (10) Suspected or confirmed history of alcohol and drug abuse (long-term use of antimicrobial drugs); (11) Patients who have participated in other clinical trials or are participating in other clinical trials within three months before screening; (12) Those with allergies or allergies to Baowu Kang suppositories or metronidazole and pyrroles; (13) Patients who cannot be followed up on time (according to the judgment of the study, patients who have circumstances that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in working environment, unstable living environment, etc.); (14) Other conditions that the investigator considers unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bacteriological efficacy;Clinical cure rate;Combined efficacy;The proportion of patients with vaginal microecology improved compared with baseline;Bacteriological efficacy (Nugent score); | — |
Countries
China
Contacts
Public ContactWu Ruifang
Peking University Shenzhen Hospital
Outcome results
None listed