Clinical trial of comparison the effect of tinidazole and metronidazole tablet for treatment and recurrence of bacterial vaginosis in women of reproductive age
This study is a double-blind randomized clinical trial that compare effect of tinidazole and metronidazole oral tablet for treatment and recurrence of bacterial vaginosis. In this study, 110 nonpregnant married women aged between 15-45 years with bacterial vaginosis were configurated in two treatment groups. Clinical diagnosis is based on the combination of any three of the following four Amsel criteria: thin homogeneous vaginal discharge, PH of vaginal discharge more than 4.5, positive wiff test, clue cells on microscopic examination of vaginal fluid. Tinidazole tablet was given to one group (2 g daily for two days) and metronidazole tablet was given to another group (500 mg twice daily for seven day). Patients were followed after two and four weeks. Improvement was defined as being less than three Amsel criteria.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012073110457N1
Registration date:2013-03-20, 1391/12/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-20, 1391/12/30
Registrant information
Name
zeinab Rabee
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences,Ahvaz,Iran
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8383
Email address
rabee@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences,Ahvaz,Iran
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-01-19, 1391/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison the effect of tinidazole and metronidazole tablet for treatment and recurrence of bacterial vaginosis in women of reproductive age
Public title
The effect of tinidazole for treatment and recurrence of bacterial vaginosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 45-15 years, married women, diagnosis of bacterial vaginosis by clinical signs and diagnostic tests, accept the use of condoms during treatment. Exclusion criteria: associated with Candida vaginitis and trichomonas, Pregnancy, consume antibiotics at the same time or within two weeks and using the vaginal cream, metronidazole used simultaneously to any cause, having a chronic disease and diabetes, Immunosuppression or immune-lowering medication use, having cervicitis, chronic bacterial vaginosis
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
For blinding the study, drug usage was explained to another person and was asked her to package drug similarly and naming them for example drug a , drug b, then give the first suitable patient drug a and next patient drug b,then explain drug usage to them. At this way , drug were given alternately and ask patients refer to us after two and four weeks for following up the treatment and recurrence
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Ethics committee of Jundishapur University of Medical Sciences,Ahvaz,Iran
Street address
Golestan Street-Ahvaz Jundishapur University of Medical Sciences,Ahvaz,Iran
City
Ahvaz Jundishapur University of Medical Sciences,Ahvaz,Iran
Postal code
61357-15794
Approval date
2012-07-20, 1391/04/30
Ethics committee reference number
eth-535
Health conditions studied
1
Description of health condition studied
Bacterial vaginosis
ICD-10 code
N76.0
ICD-10 code description
Acute vaginitis
Primary outcomes
1
Description
Vaginal discharge
Timepoint
Pre intervention, two and four weeks after treatment
Method of measurement
Observation
2
Description
Vaginal PH
Timepoint
Pre intervention.two and four weeks after treatment
Method of measurement
Universal indicator paper
3
Description
Wiff test
Timepoint
Pre intervention,two and four weeks after treatment
Method of measurement
KOH
4
Description
Clue cell
Timepoint
Pre intervention, two and four weeks after treatment
Method of measurement
Pap smear
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1, Tinidazole, oral tablet, 2 g daily for two day,brand name:Tindamax, Manufacturer:Kimidaru