Women aged 18-45 diagnosed with bacterial vaginosis based on Amsel criteria and Nugent score, not an immunocompromised hots. Bacterial vaginosis, metronidazole, vaginal administration,oral formulation, efficacy and safety
Conditions
Interventions
Participants in this group will receive oral metronidazole 800 mg (2 tablets of 400 mg each) administered intravaginally (inserted into the vagina) once daily before bedtime for 7 consecutive days.,Pa
Experimental Other,Active Comparator Other
Intravaginal group,Oral group
Sponsors
Buri Ram Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18-45 years. 2. Diagnosed with Bacterial Vaginosis (BV) based on Amsel criteria (at least 3 out of 4 criteria: abnormal vaginal discharge, vaginal pH > 4.5, positive whiff test, and presence of clue cells >20%). 3. Willing to provide informed consent and comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Known allergy or hypersensitivity to metronidazole or nitroimidazole derivatives. 2. Pregnant, planning to become pregnant during the study, or breastfeeding. 3. Presence of other vaginal infections (e.g., vulvovaginal candidiasis or Trichomonas vaginalis infection). 4. Use of antibiotics or antifungal medications within 14 days prior to enrollment. 5. Chronic medical conditions such as porphyria, severe liver disease, epilepsy, severe hematological disorders, or immunocompromised status. 6. Regular alcohol consumption or inability to abstain from alcohol during the study and for 48 hours after the last dose of metronidazole. 7. Use of medications that may interact with metronidazole (e.g., warfarin, lithium, disulfiram).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical cure from signs and symptoms improvement 14 days yes,no/ clinical and microscopic assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse effects of the treatment 14 days and 1 month yes,no/interview,recurrence rate 1 month yes,no/ clinical and microscopic assessment,patient satisfaction 1 month satisfaction score | — |
Countries
Thailand
Contacts
Public ContactSiriphen Uengphinitphong
Buri Ram Hospital
Outcome results
None listed