Condition 1: Bacterial vaginosis. Condition 2: Bacterial vaginosis. Condition 3: Bacterial vaginosis. Female pelvic inflammatory disease, unspecified Female pelvic inflammatory disorders in other diseases classified elsewhere Other specified inflammation of vagina and vulva
Conditions
Interventions
Intervention 1: Intervention group: After diagnosis bacterial vaginosis, in addition to Metronidazole tablet 250 milligrams 3 times a day (each 8 hours) for 7 days, the patient's will be used Prebioti
Treatment - Drugs
Placebo
Intervention group: After diagnosis bacterial vaginosis, in addition to Metronidazole tablet 250 milligrams 3 times a day (each 8 hours) for 7 days, the patient's will be used Prebiotic vaginal gel on
The control group will use Metronidazole tablet 250 milligrams 3 times a day (each 8 hours) for 7 days and placebo vaginal gel one applicator (5 milligrams) every night for 7 nights
Sponsors
Vice chancellor for research, Tabriz University of Medical Sciences
Women’s Reproductive Health Research Center, Tabriz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 18 to 35 years old; married; diagnosis of bacterial vaginosis with contemporary presence of at least 3 out of 4 Amsel criteria and gain score 4 to 6 with clue cells or score 7 to 10 without clue cells in the Nugent scoring system; have willing to participate to study; husband’s monogamous; absence of menstruation during the intervention. Exclusion criteria: pregnant or breastfeeding, or menopause; having abnormal vaginal bleeding; consumption of vaginal medication; douching during 48 hours ago; use of alcohol and smoking; use of anticoagulants such as Coumadin and Disulfiram; having other vaginal infections such as candidiasis and trichomoniasis; having known medical disease such as diabetes, thyroid disease and liver diseases according to patient’s report; not having tendency to use prebiotic gel.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical and laboratory criteria based on Amsel and Nugent scoring system. Timepoint: Baseline, 10±1 day after intervention, 12±1 week after intervention. Method of measurement: Measured by clinical measurements of diseases and laboratory tests.;Malodon discharge. Timepoint: Baseline, 10±1 day after intervention, 12±1 week after intervention. Method of measurement: Measured by asking from patient.;Itching. Timepoint: Baseline, 10±1 day after intervention, 12±1 week after intervention. Method of measurement: Measured by asking from patient.;Dyspareunia. Timepoint: Baseline, 10±1 day after intervention, 12±1 week after intervention. Method of measurement: Measured by asking from patient.;Having bad smell during sexual intercourse. Timepoint: Baseline, 10±1 day after intervention, 12±1 week after intervention. Method of measurement: Measured by asking from patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of vaginal pH. Timepoint: Baseline, 10±1 day after intervention, 12±1 week after intervention. Method of measurement: pH paper scale.;Client satisfaction. Timepoint: Baseline, 10±1 day after intervention, 12±1 week after intervention. Method of measurement: Self-report.;Change in Clue cells. Timepoint: Baseline, 10±1 day after intervention, 12±1 week after intervention. Method of measurement: direct observation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSevil Hakimi
Tabriz University of Medical Sciences
Outcome results
None listed