This research is done to compare clinical response of patients with recurrent vulvovaginal candidiasis to boric acid and leukorex (zataria multiflora).
This study was performed as a double blind clinical trial in control with positive cases (parallel). Patients with recurrent vaginal candidiasis that had positive results of vaginal transpiration tests, without any predisposing factors were enrolled in this survey. Vaginal cream of zataria multiflora 1% and boric acid 3% were given them blindly. Signs and symptoms were analyzed in first visit, 1 and 6 months after starting the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012102911302N1
Registration date:2012-12-17, 1391/09/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-17, 1391/09/27
Registrant information
Name
Maryam Rabiee
Name of organization / entity
Shahed University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 9438
Email address
rabiee@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Herbal medicine center of Shahed University - Barig essanse of Kashan
Expected recruitment start date
2010-03-20, 1388/12/29
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical response to vaginal cream zataria multiflora and boric acid in patients with recurrent vulvovaginal candidiasis.
Public title
Comparison the effect of leucrex and boric acid in recurrent candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Females were at 18- 55 ages; they have gotten itching, burning of vulvovagina, dysuria, white vaginal discharge; these symptoms have relapsed for 4 or more than 4 times in the last year. Exclusion criteria: Users of oral contraceptive pill; long term using antibiotic; immunosuppressant; having chronic disease such as diabetes, nephrotic syndrome and autoimmune diseases
Age
From 18 years old to 55 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
62
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
Shahed University
Street address
Opposit of haram Imam Khomainie, Blv Khalij Fars, Teran
City
Tehran
Postal code
3319118651
Approval date
2007-09-23, 1386/07/01
Ethics committee reference number
651/15
Health conditions studied
1
Description of health condition studied
recurrent vulvovaginit candidiasise
ICD-10 code
N76.1
ICD-10 code description
Subacute and chronic vaginitis
Primary outcomes
1
Description
response to therapy
Timepoint
1-6 months after trearment
Method of measurement
obsevation
Secondary outcomes
1
Description
sensivity after using drug
Timepoint
Just at time using drug
Method of measurement
observation
Intervention groups
1
Description
Vaginal cream zataria multiflora1% was tested on 31 patients, at first they used it every night, for two weeks,then they used it five nights in a month, for six months
Category
Treatment - Drugs
2
Description
Vaginal cream boric acid 3% was tested on 31 patients, at first they used it every night, for two weeks, then they used it five nights in a month, for six months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zaynab hospital
Full name of responsible person
Mrs maryam Rabiee
Street address
Shaheed Moosavie cross over, Somayeh street
City
Tehran
2
Recruitment center
Name of recruitment center
Shaheed Mostafa Khomainiee hospital
Full name of responsible person
Mrs Maryam Rabiee
Street address
Italia street, Kashavars Blv
City
Tehran
3
Recruitment center
Name of recruitment center
Fajr hospital
Full name of responsible person
Mrs Maryam Rabiee
Street address
Piroozie street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Herbal medicine of shahed unversity
Full name of responsible person
Shikoohie Mrs
Street address
Blv Khalij fars opposit of imam khomainie haram
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Herbal medicine of shahed unversity
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
Shahed Univaesity
Full name of responsible person
Mrs Maryam rabiee
Position
Assosiated proffessor ob .gyn group
Other areas of specialty/work
Street address
Ab street, Kashavarz Blv, Shahed University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8896 3849
Fax
Email
rabiee@shahed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mrs Maryam rabiee
Position
Gynecologist & Obestetrician
Other areas of specialty/work
Street address
Shahed University of Medical Sciences, Blv kashavarz, Ab street
City
Tehran
Postal code
Phone
+98 21 8896 9438
Fax
Email
dr_rabi_maryam@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mrs Maryam Rabiee
Position
Gynecologist& Obestetrician
Other areas of specialty/work
Street address
Shahed University of Medical Sciences, Ab Street, Kashavars Blv
City
Postal code
Phone
+98 21 8896 3849
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)