A comparative study of the therapeutic effect of the propolis Vaginal cream and clotrimazole On Candida vulvovaginitis in reproductive aged women referring to shiraz gynecology clinics (2009
This study was carried out to compare the effect of Propolis vaginal cream with Clotrimazole on the treatment results of candidiasis vulvoginitis . The subjects consisted of reproductive aged women (above 18 years and in premenopause age) who were not pregnant. From the viewpoint of clinical complaints and laboratory culture, all the patients were diagnosed to be afflicted. If the subjects were not considered patient according to the culturing were eliminated from the study. This clinical trial was conducted on 100 reproductive aged women for a period of 8 months .They were divided into two groups of 50 subjects(Clotrimazole and Propolis) by randomized allocation method. all the patients applied the drug once a day for 10 days only. The results were compared after 10 days of therapy and reculturing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138805192325N1
Registration date:2010-05-25, 1389/03/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-25, 1389/03/04
Registrant information
Name
Mahsa Sadat Mousavi
Name of organization / entity
Khorasgan (Isfahan) Branch, Islamic Azad University, Isfahan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 31 3272 4301
Email address
moosavimh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2009-04-21, 1388/02/01
Expected recruitment end date
2009-12-22, 1388/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the therapeutic effect of the propolis Vaginal cream and clotrimazole On Candida vulvovaginitis in reproductive aged women referring to shiraz gynecology clinics (2009
Public title
A comparative study of the therapeutic effect of the propolis Vaginal cream and clotrimazole On Candida vulvovaginitis in reproductive aged women referring to shiraz gynecology clinics (2009)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: willingness to participate, reproductive age (between 18 years and premenopause age.
Exclusion Criteria: pregnancy, breast feeding, using hormonal or immunosuppressive drugs, having sexually transmitted and autoimmune diseases or any other disease such as diabetes, allergy to Azole drugs, using antibiotics, antifungal compounds or vaginal drugs during two weeks prior to the study, suffering from recurrent vulvovaginitis (4 times or more during one year), using other supportive treatments like vaginal douch at the time of drug application, negative culture
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Shiraz University of Medical Sciences
Street address
Shiraz Zand St.
City
Shiraz
Postal code
Approval date
2009-10-05, 1388/07/13
Ethics committee reference number
ct 88-4556
Health conditions studied
1
Description of health condition studied
Candidia Vulvovaginitis
ICD-10 code
N76.0
ICD-10 code description
acute vaginitis
Primary outcomes
1
Description
therapeutic results of Candida vulvovaginitis
Timepoint
10 days
Method of measurement
culture
Secondary outcomes
empty
Intervention groups
1
Description
Propolis vaginal cream 10%, one applicator per day, for 10 days
Category
Treatment - Drugs
2
Description
Clotrimazole vaginal cream 10%, one applicator per day, for 10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology clinic of zeinabieh hospital
Full name of responsible person
Street address
Zeinabieh hospital, Khatoon Sq., Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammad Hosein Dabbagh Manesh
Street address
Zand St., Shiraz
City
Shiraz
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, Shiraz 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
Fatemeh (PBUH) college of Nursing and Midwifery Shiraz University of Medical Sciences