A comparison between the effect of vaginal probiotic capsules and the oral tablet of Metronidazol on combined bacterial and trichomonial vaginitis in selected gynecology clinics of Shiraz University of Medical Science, 1390
The present study aims to compare the effects of vaginal probiotic capsules and the oral tablet of Metronidazole on combined bacterial and trichomonial vaginitis. This randomized, single blind study is conducted on 100 females suffering from combined bacterial and trichomonial vaginitis. The study subjects are divided into two groups of 50 through random allocation. The diagnosis criteria are wet smear and gram stain. For group 1, vaginal probiotic capsules are prescribed for 10 days, while for the second group, oral tablets of metronidazole are prescribed for 7 days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711201548N3
Registration date:2012-05-07, 1391/02/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-05-07, 1391/02/18
Registrant information
Name
Khadijeh Abdali
Name of organization / entity
Fatemeh college of nursing and midwifery, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4255
Email address
abdalikh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for research of Shiraz university of medical sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-06-20, 1391/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between the effect of vaginal probiotic capsules and the oral tablet of Metronidazol on combined bacterial and trichomonial vaginitis in selected gynecology clinics of Shiraz University of Medical Science, 1390
Public title
A comparison between the effect of vaginal probiotic capsules and the oral tablet of Metronidazol on combined bacterial and trichomonial vaginitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria of the study: Non-pregnant, non-lactating, and non-smoker women who aged between 18 and 55, being married, being willing to participate in the research, being in the follicular phase of the menstrual cycle, having signs of trichomoniasis on physical examination, having signs of bacterial vaginosis on physical examination, not having abnormal vaginal bleeding at the time of sampling, not having vaginal intercourse and douching during 48 hours prior to the study, not taking vaginal medication, such as creams, suppositories, and vaginal disinfectants in 48 hours before the study, not taking medication for treatment during the last 3 months, not suffering from specific diseases, such as liver, heart, and kidney diseases, diabetes, central nervous system diseases, blood discrasia, immune system defects, and known sexually transmitted diseases, not having used broad-spectrum antibiotics, anti-prostaglandins, hormone and immunosuppressive drugs, alcohol, and anticoagulation in recent months, no history of sensitivity to metronidazole tablets, not having vulvovaginitis four or more times during the year, and not having multiple sexual partners.
Exclusion criteria of the study: Having allergy to the elements of the probiotic products which were used in the study, being considered unhealthy based on the clinical diagnosis, while having negative test results, and having allergy to the medication compounds used in the study.
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Research Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences
City
shiraz
Postal code
Approval date
2011-12-01, 1390/09/10
Ethics committee reference number
CT-90-5809
Health conditions studied
1
Description of health condition studied
Trichomonas vaginitis
ICD-10 code
A59
ICD-10 code description
Urogenital trichomoniasis
2
Description of health condition studied
Trichomonas vaginitis
ICD-10 code
A59
ICD-10 code description
Urogenital trichomoniasis
Primary outcomes
1
Description
Gram stain,wet smear and clinical signs
Timepoint
Before intervention,1week and 10 days after intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
Side effects
Timepoint
7-10 days after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
vaginal probiotic capsule,once daily until 10 day
Category
Treatment - Drugs
2
Description
Control group: standard treatment with oral metronidazole 250 mg tablet every 12 hours, 2 to 7 days.