Effect of Complementary therapy of vaginal prebiotic gel with metronidazole tablet on treatment and recurrence of bacterial vaginosis: a randomized controlled trial
- Conditions
- Condition 1: Bacterial vaginosis. Condition 2: Bacterial vaginosis. Condition 3: Bacterial vaginosis.Female pelvic inflammatory disease, unspecifiedFemale pelvic inflammatory disorders in other diseases classified elsewhereOther specified inflammation of vagina and vulva
- Registration Number
- IRCT2015121721917N5
- Lead Sponsor
- Vice chancellor for research, Tabriz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 100
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.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.