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Effect of lactobacillus and metronidazole vaginal suppository compared with metronidazole alone on improvement and recurrence of bacterial vaginosis

Protocol summary

Summary
A clinical trial study is to compare the effect of lactobacilli and metronidazole with metronidazole alone on the recovery and recurrence of bacterial vaginitis. This is a randomized, blinded, placebo-controlled, multi-stage study, which is performed on two groups of 65 women with bacterial vaginitis at the Imam Khomeini hospital of Ahvaz. The primary inclusion criteria are: married women (15-45 years old); exclusion criteria are: pregnancy, having other infections, and so on. In this study, after obtaining permission and get a referral from the Nursing and midwifery school of Medicine and Ahvaz Imam Khomeini hospital, 130 married women 15-45 years old, who complained of a smelly discharge, vaginal or genital irritation symptoms, entered the study in order to diagnose bacterial vaginitis based on clinical Amsel criteria. After informed consent of the patients was obtained, they are divided into two groups, and two lactobacillus vaginal suppositories daily along with oral metronidazole 500 mg twice a day for a week is given to a group and controls for a week once the two numbers together with the placebo day suppositories 500 mg metronidazole orally. Slides in the laboratory are interpreted by a laboratory technician and the checklist was completed. After a week of treatment, and 4 weeks later to improve relapse are reviewed and analyzed.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2013071914057N1
Registration date: 2014-03-08, 1392/12/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-03-08, 1392/12/17
Registrant information
Name
Soror Roozafzay
Name of organization / entity
Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 4322 1114
Email address
roozafzay.s@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2013-06-20, 1392/03/30
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lactobacillus and metronidazole vaginal suppository compared with metronidazole alone on improvement and recurrence of bacterial vaginosis
Public title
Effect of lactobacillus and metronidazole vaginal suppository compared with metronidazole alone on improvement and recurrence of bacterial vaginosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 15 to 45; married women; no underlying disease Exclusion criteria: Pregnancy; Having other infections; antibiotics in the last 6 months
Age
From 15 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the research deputy of Ahvaz University of Medical Sciences
Street address
Ahvaz, Expressway, Golestan University of Medical Sciences, Ahvaz,
City
Ahvaz
Postal code
6135715794
Approval date
2013-06-08, 1392/03/18
Ethics committee reference number
Ajumf.iec.1392.57

Health conditions studied

1

Description of health condition studied
bactrial vaginosis
ICD-10 code
1
ICD-10 code description
Bactrial infection, unspecified

Primary outcomes

1

Description
Diagnosis of Bactrial Vaginosis
Timepoint
Before treatment, one month after the treatment
Method of measurement
Based on Amsel criteria , PH Measurement Kit Merck, Germany

Secondary outcomes

1

Description
Measurment of Vaginal discharge
Timepoint
Before treatment, one monthafter the treatment
Method of measurement
Amsel criteria , PH Measurement Kit Merck, Germany

Intervention groups

1

Description
The group 1 receives oral metronidazole with Lactobacillus vaginal suppositoriesn
Category
Treatment - Drugs

2

Description
Group 2 receives metronidazole and placebo.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital, Ahvaz,Azadegan Street
Full name of responsible person
Research Council of Medical Sciences, Ahvaz,
Street address
Ahvaz Imam Khomeini Hospital, Ahvaz,Azadegan Street
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Department of Medicine, Ahwaz University users
Street address
Ahvaz Jundishapur University of Medical Sciences,Golestan Blvd, Ahvaz
City
Ahvaz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Medical Sciences, Ahvaz,
Full name of responsible person
khadijeh Hekmat
Position
Nursing graduate/ faculty member
Other areas of specialty/work
Street address
Ahvaz School of Nursing and Midwifery
City
Ahvaz
Postal code
6135715794
Phone
+98 61 1333 2368
Fax
-
Email
roozafzay.s@ajums.ac.irsoror.roozafzay@yahoo.com
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur of Medical Sciences
Full name of responsible person
khadejeh Hekmat
Position
Master of Midwifery
Other areas of specialty/work
Street address
Ahvaz,Golestan Blvd, University of Medical Sciences, Ahvaz,
City
Ahvaz Jundishapur of Medical Sciences
Postal code
6135715794
Phone
+98 61 1333 2368
Fax
-
Email
roozafzay.s@ajums.ac.irsoror.roozafzay@yahoo.com
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur of Medical Sciences
Full name of responsible person
Soror Roozafzay
Position
Graduate Student Midwives
Other areas of specialty/work
Street address
Ahvaz,Golestan Blvd, University of Medical Sciences, Ahvaz,
City
Ahvaz
Postal code
6135715794
Phone
+98 74 4322 1114
Fax
-
Email
roozafzay.s@ajums.ac.irsoror.roozafzay@yahoo.com
Web page address
-

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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