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ISRCTN
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ISRCTN18987156
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ClinicalTrials.gov identifier
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Public title
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Randomised clinical trial comparing the efficacy between metronidazole and Shinus terebinthifolius Raddi (called aroeira) in vaginal use for the treatment of bacterial vaginosis
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Bacterial vaginosis is a polymicrobial clinical syndrome where the Lactobacillus are replaced by anaerobic bacteria, Gardnerela vaginalis and Mycoplasma hominis.
The study hypothesis is that metronidazole and aroeira have similar efficacy in the treatment of bacterial vaginosis, but aroeira has less impact in the vaginal flora, because it is a natural substance, extracted from a tree caulis.
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Ethics approval
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Ethical Commitee in Research of the Instituto Materno Infantil (c/o Prof Fernando Figueira) approved in March 2007.
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Study design
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Randomised double-blind controlled trial.
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Countries of recruitment
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Brazil
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Disease/condition/study domain
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Bacterial vaginosis
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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20/06/2007
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Anticipated end date
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20/06/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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300 women
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Interventions
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The participants will be randomised into two groups of 150 women:
Control group: Metronidazole gel 0.75%, intravaginally, once a day for seven days.
Intervention group: Schinus terebinthifolius Raddi (aroeira) gel 3,996 ml/6 g, intravaginally, once a day for seven days.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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1. To compare the frequencies of the adverse effects of the two drugs
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)
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)
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Sources of funding
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The vaginal treatments will be provided by Laboratório Hebron (www.hebron.com.br) (Brazil). The assessments will be carried out at the Instituto Materno Infantil (Brazil) - c/o Prof Fernando Figueira, where the study will take place.
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Trial website
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Publications
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Contact name
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Prof
Ricardo
Ximenes
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Address
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Universidade Federal de Pernambuco
Departamento de Medicina Tropical
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City/town
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Recife
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Zip/Postcode
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50670-421
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Country
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Brazil
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Sponsor
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Institute for Maternal/Infant Health (IMIP) (Brazil)
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Address
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Rua dos Coelhos
300 - Boa Vista
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City/town
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Recife
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Zip/Postcode
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50070-550
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Country
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Brazil
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Sponsor website:
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http://www.imip.org.br/
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Date applied
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18/06/2007
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Last edited
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21/09/2007
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Date ISRCTN assigned
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06/07/2007
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