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
Protocol serial number	N/A
Sponsor	Institute for Maternal/Infant Health (IMIP) (Brazil)
Funder	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.

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

Universidade Federal de Pernambuco
Departamento de Medicina Tropical
Recife
50670-421
Brazil

Study information

Primary study design	Interventional
Study design	Randomised double-blind controlled trial.
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Metronidazole, Shinus terebinthifolius Raddi (called aroeira)
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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)
Completion date	20/06/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	300
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.