The purpose of this study is diagnosis the effects of vitamin C vaginal tablet plus oral metronidazole on treatment of bacterial vaginosis. According to this object ,a randomized double blind control trial, 160 non- pregnant, non breastfeeding women aged between 18 to 45 years old with the randomized allocation, can be considered in a way of two groups of 80 ‘s members. After bacterial vaginosis diagnosis by Amsel and Nagent criteria, intervention group will receive vitamin C vaginal tablet 250 mg with oral metronidazole ( prescribed with the dose of 500 mg twice a day ) during 7 days and control group will receive placebo vaginal tablet with oral metronidazole (with the same dose ). All of participants will be followed days of 10 ± 1 and 30 ± 3 after treatment and final diagnosis will be done according to clinical and laboratory criteria .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042521917N3
Registration date:2015-05-30, 1394/03/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-05-30, 1394/03/09
Registrant information
Name
Sevil Hakimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
hakimis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences. Women’s Reproductive Health Research Center
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of vaginal tablets of vitamin C with metronidazole on treatment of bacterial vaginosis ,clinical trials.
Public title
Effectiveness of vaginal tablets of vitamin C with metronidazole on treatment of bacterial vaginosis. (A randomised , double blind , control trial )
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: non-pregnant and non breastfeeding married women age between 18 -45 Years Old,diagnosis of bacterial vaginosis with contemporary presence of at least three out of four Amsel criteria and gain score 4 to 6 with clue cells or score 7 to 10 without clue cells in Nugent scoring system, have willing to participate to study , possibility to attending center in schedule time for post treatment follow up , husband’s monogamous , Filling the Informed Consent Form;
Exclusion criteria: chronic disease , consumption of vaginal medication or douching during the recent weeks , Immune deficiency syndrome, consumption of antibiotic during the recent weeks , consumption of rifampin –phenytoin- phenobarbital and any anticoagulant agents , other vaginal infections ,presence of unknown vaginal bleeding .
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization with the randomized allocation
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Faculty of Nursing & Midwifery, South Shariaty Street
City
Tabriz
Postal code
3417174914
Approval date
2015-04-13, 1394/01/24
Ethics committee reference number
TBZMED.REC.1394.5
Health conditions studied
1
Description of health condition studied
Bacterial Vaginosis
ICD-10 code
N70-N77
ICD-10 code description
Inflammatory diseases of female pelvic organs
Primary outcomes
1
Description
Clinical and laboratory criteria based on Amsel and Nugent scoring system .
Timepoint
Before intervention, 10 ± 1 and 30 ± 3 days after treatment.
Method of measurement
Measured by clinical measurements of diseases and laboratory tests.
2
Description
Malodon discharge
Timepoint
Before intervention, 10 ± 1 and 30 ± 3 days after treatment.
Method of measurement
Measured by asking from patient
3
Description
Itching
Timepoint
Before intervention, 10 ± 1 and 30 ± 3 days after treatment.
Method of measurement
Measured by asking from patient
4
Description
Dyspareunia
Timepoint
Before intervention, 10 ± 1 and 30 ± 3 days after treatment.
Method of measurement
Measured by asking from patient
5
Description
Having fishy smell during sexual intercourse
Timepoint
Before intervention, 10 ± 1 and 30 ± 3 days after treatment.
Method of measurement
Measured by asking from patient
Secondary outcomes
1
Description
The vaginal PH change
Timepoint
Before intervention, 10 ± 1 and 30 ± 3 days after treatment.
Method of measurement
PH paper scale
2
Description
Change in Clue Cells
Timepoint
Before intervention, 10 ± 1 and 30 ± 3 days after treatment.
Method of measurement
Measured by laboratory tests.
Intervention groups
1
Description
Intervention group will receive vitamin C vaginal tablet 250 mg which produced by Faculty of Medicine Pharmaceutical group in Tabriz university of medical science with oral metronidazole ( prescribed with the dose of 500 mg twice a day ) during 7 days .
Category
Treatment - Drugs
2
Description
Control group will receive placebo vaginal tablet along with oral metronidazole ( prescribed with the dose of 500 mg twice a day) during 7 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Samenol Aeme Hospital
Full name of responsible person
Toktam Dokhanchi
Street address
Imam khomeini square, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences. Women’s Reproductive Health Research Center
Full name of responsible person
Parvin Mostafa Ghare Baghi
Street address
Alzahra Hospital, South Artesh Ave.
City
Tabriz
Grant name
_
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences. Women’s Reproductive Health Research Center
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
Tabriz University of Medical Sciences
Full name of responsible person
Sevil Hakimi
Position
PhD of reproductive health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
3417174914
Phone
+98 41 3479 6770
Fax
Email
hakimis@tbzmed.ac.ir; hakimisevil@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sevil Hakimi
Position
PhD of reproductive health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
3417174914
Phone
+98 41 3479 6770
Fax
Email
HAKIMIS@tbzmed.ac.ir; hakimisevil@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Toktam Dokhanchi
Position
MSc student of midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
3417174914
Phone
+98 41 3479 6770
Fax
Email
tdokhanchi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)