Randomised clinical trial comparing the efficacy between metronidazole and Shinus terebinthifolius Raddi (called aroeira) in vaginal use for the treatment of bacterial vaginosis
| ISRCTN | ISRCTN18987156 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18987156 |
| Secondary identifying numbers | N/A |
- Submission date
- 18/06/2007
- Registration date
- 06/07/2007
- Last edited
- 01/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Ricardo Ximenes
Scientific
Scientific
Universidade Federal de Pernambuco
Departamento de Medicina Tropical
Recife
50670-421
Brazil
Study information
| Study design | Randomised double-blind controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Randomised clinical trial comparing the efficacy between metronidazole and Shinus terebinthifolius Raddi (called aroeira) in vaginal use for the treatment of bacterial vaginosis |
| Study objectives | 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. |
| Ethics approval(s) | Ethical Commitee in Research of the Instituto Materno Infantil (c/o Prof Fernando Figueira) approved in March 2007. |
| Health condition(s) or problem(s) studied | Bacterial vaginosis |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Metronidazole, Shinus terebinthifolius Raddi (called aroeira) |
| Primary outcome measure | 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 | 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) |
| Overall study start date | 20/06/2007 |
| Completion date | 20/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 300 women |
| Total final enrolment | 277 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 20/06/2007 |
| Date of final enrolment | 20/06/2008 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Universidade Federal de Pernambuco
Recife
50670-421
Brazil
50670-421
Brazil
Sponsor information
Institute for Maternal/Infant Health (IMIP) (Brazil)
Hospital/treatment centre
Hospital/treatment centre
Rua dos Coelhos
300 - Boa Vista
Recife
50070-550
Brazil
| Website | http://www.imip.org.br/ |
|---|---|
"ROR" |
https://ror.org/01rtyyz33 |
Funders
Funder type
Industry
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.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 14/01/2011 | 01/09/2021 | Yes | No |
Editorial Notes
01/09/2021: Publication reference and total final enrolment added.
