This study was a double-blind randomized controlled trial. The aim of this study was to compare the ability of Sucrose and Metronidazole vaginal gel for treatment of bacterial vaginosis. In this study, 70 non-pregnant married women 15-45 years old with bacterial vaginosis were randomly assigned to two treatment groups (35 women in each group). Diagnostic criteria for bacterial vaginosis in this study was considered to be three of Amsel's criteria including: homogeneous vaginal discharge, PH of vagina ≥4.5, positive Whiff test and presence of key cells invaginal wet smear. The intervention group was prescribed Sucrose vaginal gel and the metronidazole group was prescribed Metronidazole vaginal Gel twice-a-day for 5 days. Patients were recommended to come back for follow-up 14 days after completion of treatment. In the follow-up visit, vaginal samples from all patients were taken. All results were recorded in the check lists of patients. Improvment was considered as having less than 3 Amsel's criteria.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112631105N1
Registration date:2016-12-27, 1395/10/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-27, 1395/10/07
Registrant information
Name
Somayyeh Khazaeian
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3323 1207
Email address
somayeh.khazaiyan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research and Technology, Zahedan University of Medical Sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Sucrose gel with Metronidazole gel in the treatment of women with bacterial vaginosis
Public title
Comparison the effect of Sucrose gel with Metronidazole gel in the treatment of bacterial vaginosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Married women of reproductive age (15 to 45 years old); Positive Gram staining of bacterial vaginosis; Bacterial vaginosis symptoms on clinical examination; Non-current use of anti-parasitic drugs, antibiotics, immunosuppressive drugs and vaginal medications during the past two weeks; Lack of abnormal uterine bleeding; Not having recurrent vaginitis (4 or more than 4 times a year); No pregnancy; No breastfeeding; No use douching frequently; No alcohol and anticoagulant coumarin; No cases of multiple sex partners; No getting certain diseases, such as liver disease, diseases of the central nervous system, blood Dyscrasia, diabetes, immune deficiency; No history of allergy to mint category and garlic taken orally or topically. Exclusion criteria: Sensitivity to the drug and non-drug use; taking any prescribed medications with conflicting effect with medicines in this study; taking any drug that affect vaginosis symptoms and treatment; lack of patients interest
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committee of Zahedan University of Medical Sciences
Street address
Pardis University of Medical Sciences Campus, Hessabi Sq
City
Zahedan
Postal code
Approval date
2011-10-04, 1390/07/12
Ethics committee reference number
90-1305
Health conditions studied
1
Description of health condition studied
Bacterial vaginosis
ICD-10 code
N76.8
ICD-10 code description
Other specified inflammation of vagina and vulva
Primary outcomes
1
Description
Vaginal discharge
Timepoint
Before the intervention, two weeks after intervention
Method of measurement
Observation
2
Description
Wiff test
Timepoint
Before the intervention, two weeks after intervention
Method of measurement
Potassium hydroxide solution 10%
3
Description
Number key cells
Timepoint
Before the intervention, two weeks after intervention
Method of measurement
Gram stain
Secondary outcomes
empty
Intervention groups
1
Description
The samples used a 70-gram tube from Sucrose gel in 5 days.
Category
Treatment - Drugs
2
Description
The samples used a 70-gram tube from Metronidazole gel in 5 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Ali Ibn Abi Talib (AS)
Full name of responsible person
Dr. Batool Teimoori
Street address
Hospital Ali Ibn Abi Talib
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Zahedan University of Medical Sciences
Full name of responsible person
Dr.Mohsen Taheri
Street address
Pardis University of Medical Sciences Campus, Hessabi Sq
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research and Technology, Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Mahdiye Donyadari
Position
MSc
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mashahir Sq
City
Zahedan
Postal code
Phone
+98 54 3343 8473
Fax
Email
m_20282000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Shahin_ Dokht Navvabi Rigi
Position
Faculty of Midwifery / MSc
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mashahir Sq
City
Zahedan
Postal code
Phone
+98 54 3341 6706
Fax
Email
shahinnavabi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Somayyeh Khazaeian
Position
Faculty of Midwifery / MSc
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mashahir Sq
City
Zahedan
Postal code
98167-43463
Phone
+98 54 3341 6708
Fax
Email
m_khazaiyan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)