Randomised clinical trial comparing the efficacy between metronidazole and Shinus terebinthifolius Raddi (called aroeira) in vaginal use for the treatment of bacterial vaginosis
Not Applicable
Completed
- Conditions
- Bacterial vaginosisInfections and Infestations
- Registration Number
- ISRCTN18987156
- Lead Sponsor
- Institute for Maternal/Infant Health (IMIP) (Brazil)
- Brief Summary
2011 Results article in https://pubmed.ncbi.nlm.nih.gov/21243318/ (added 01/09/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 277
Inclusion Criteria
1. Women aged between 18 and 40 years
2. Women with vaginal discharge caused by bacterial vaginosis, diagnosed using the Amsel (clinical) and Nugent (Gram stein) criteria
Exclusion Criteria
1. Pregnant women
2. Women using antibiotics for other infections in the last 30 days
3. Women using any other vaginal treatment in the last 30 days
4. Women who have never had sexual intercourse
5. Women with other vaginal infections such as candidiasis or trichomoniasis
6. Women with a suggestive diagnosis of pelvic inflammatory disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the frequency of the clinical (Amsel Criteria) and bacteriological (Nugent criteria) cure assessed at baseline and after their next menses (approximately one month after therapy) between the two groups.
- Secondary Outcome Measures
Name Time Method <br> 1. To compare the frequencies of the adverse effects of the two drugs<br> 2. To compare the frequencies of the effects in the vaginal flora, observing the presence of lactobacillus in Papanicolaou smears at baseline and after their next menses (approximately one month after therapy)<br> 3. To compare the frequencies of the effects of the two treatments by the presence of bacterias and fungi in vaginal cultures at baseline and after their next menses (approximately one month after therapy)<br>