This study compares the effects of garsin tablet (made of garlic) and metronidazole tablet on treatment of bacterial vaginosis. This study is a randomized clinical trial (single blind) which is conducted on 140 married women, aged 18 – 44years old, with single partner whose infection with bacterial vaginosis is diagnosed through clinical Amsel criteria and laboratory Nugent criteria. Identified patients with cervicitis, tricamona or candidiadis infections are excluded from the study. They should not use IUD. Also they should not use antibiotics, vaginal drug or immunosuppressive drugs in recent fourteen days. They should not be pregnant, lactating or menopause. They should not have mental retardation or known physical disease; suffering from thyroid disease; coagulation disorders; diabetes and autoimmune diseases. Exclusion criteria: Not tolerate any form of drug or discontinuation for at least 48 hours, become pregnant during treatment, forcing the use of antibiotics during treatment. The participants are randomly divided into two groups of 70 persons each: garsin tablet (two 500 mg tablets, twice a day) and metronidazole tablet (two 250 mg tablets, twice a day). Treatment period in each group lasts seven days. Clinical Amsel criteria and laboratory Nugent criteria will be again checked 7 to 10 days after beginning of the treatment period and the side - effects will be registered. Independent variables in this study are garsin tablet and metronidazole tablet and the dependent variable is bacterial vaginosis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207153226N4
Registration date:2013-12-20, 1392/09/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-20, 1392/09/29
Registrant information
Name
Mahrokh Dolatian
Name of organization / entity
Shahid Beheshti University of Medical Scenices
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
m_dolatian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
The International Branch of shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-12-16, 1392/09/25
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effects of garsin tablet ( made of garlic ) and metronidazole tablet on treatment of bacterial vaginosis
Public title
The comparison of the effect of garsin and metronidazole on bacterial vaginosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: married women; aged 18-44 years old, with single partner whose infection with bacterial vaginosis is diagnosed through clinical Amsel criteria and labratory Nugent criteria ( Patients identified with cervicitis tricamona or candidiadis infections are excluded from the study); they should not use IUD. Also they should not use antibiotics, vaginal drug or immunosuppressive drugs in recent fourteen days. During clinical examination they should not have any breakthrough bleeding or menstrual period. They should not be pregnant, lactating or menopause. They should not have mental retardation or known physical disease; suffering from thyroid disease; coagulation disorders; diabetes and autoimmune diseases. Exclusion criteria: not tolerate any form of drug or discontinuation for at least 48 hours, become pregnant during treatment, forcing the use of antibiotics during treatment.
Age
From 18 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
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
The International Branch of Shahid Beheshti university of medical sciences & health sciences
Street address
No.19, Adjacent to Hemmat bridge, shaheed Abbaspour ave, Valiasr street,Tehran.Iran
City
Tehran
Postal code
7413934358
Approval date
2013-10-07, 1392/07/15
Ethics committee reference number
2880/116
Health conditions studied
1
Description of health condition studied
Bacterial vaginosis infection
ICD-10 code
N77
ICD-10 code description
Vulvovaginal ulceration and inflammation in diseases classified elsewhere
Primary outcomes
1
Description
Amsel criteria
Timepoint
Before the intervention, 7-10 days after begining of treatment
Method of measurement
Amsel have 4 criteria: key cells in the wet mount vaginal sample Vaginal dyscharge thin and white uniform - gray, white or yellowish, Vaginal pH equal to or greater than 4/5, positive whiff test. If at least 3 of the 4 cases mentioned above is positive, bacterial vaginosis is brought on .
2
Description
Nugent criteria
Timepoint
Before the intervention, 7-10 days after beginning treatment
Method of measurement
These criteria are based on the observation lactobacil and other morphotype (Gardnerella vaginalis and Mobiluncus forms) are rated from zero to 10 points, a total score of 7-10 means abnormal vaginal flora (bacterial vaginosis), grades 4-6 (Intermediate) in this study means abnormal vaginal flora. normal flora score is 0-3.
Secondary outcomes
1
Description
bacterial vaginosis infection
Timepoint
Before the intervention, 7-10 days after beginning treatment
Method of measurement
Clinical complaint questionnaires are completed by samples (itching, burning, abnormal discharge, smelly discharge).
Intervention groups
1
Description
One group Metronidazole 250 mg tablet, twice daily 500 mg (every 12 hours) with food for 7 days
Category
Treatment - Drugs
2
Description
the other group Garsin 500 mg tablet, twice daily 1000 mg (every 12 hours) with meal for 7 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Resalat Health Center
Full name of responsible person
farnaz mohammadzadeh
Street address
Taleb amoli street, daryeye 38 ave.
City
Amol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The International Branch of Shahid Beheshti university of medical sciences
Full name of responsible person
Mrs Dr Ghanati
Street address
No.19, Adjacent to Hemmat bridge, shaheed Abbaspour ave, Valiasr street,Tehran.Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The International Branch of Shahid Beheshti 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
The International Branch of Shahid Beheshti university of medical sciences
Full name of responsible person
Farnaz Mohammadzadeh
Position
M.Sc Student of Midwifery
Other areas of specialty/work
Street address
St. Valiasr, intersection of Valiasr -Niyayesh, School of nursing and midwifery, shaheed Beheshti University of Medical Sciences
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
farnaz.mohammadzade@gmail.com; sbnmf@sbmu.ac.ir
Web page address
www.ivbs.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The International Branch of Shahid Beheshti university of medical sciences
Full name of responsible person
Farnaz Mohammadzadeh
Position
M.Sc Student of Midwifery
Other areas of specialty/work
Street address
St. Valiasr, intersection of Valiasr -Niyayesh, School of nursing and midwifery, shaheed Beheshti University of Medical Sciences
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
farnaz.mohammadzade@gmail.com; sbnmf@sbmu.ac.ir
Web page address
www.ivbs.ir
Person responsible for updating data
Contact
Name of organization / entity
The International Branch of Shahid Beheshti university of medical sciences
Full name of responsible person
Farnaz Mohammadzadeh
Position
M.Sc Student of Midwifery
Other areas of specialty/work
Street address
St. Valiasr, intersection of Valiasr -Niyayesh, School of nursing and midwifery, shaheed Beheshti University of Medical Sciences
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
farnaz.mohammadzade@gmail.com; sbnmf@sbmu.ac.ir
Web page address
www.ivbs.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)