Objective: The present study was designated to compare the antifungal activities of clotrimazole and methanol extract M. communis in the treatment of Vulvovaginal candidiasis in- vivo. Methods: A double-blind, randomized, clinical trial was conducted in health clinics of Dezful, in the southwest of Iran . Of 276 women admitted, 70 eligible women with Vulvovaginal candidiasis (according symptoms, pH of vagina, and vaginal culture) were randomly assigned into two treatment groups. There was no significant difference between the two groups regarding characteristic of age, parity, contraceptive method and educational level. In group 1, 35 women were assigned to receive 5 gr. of vaginal clotrimazole and in group 2, 35 women were assigned to receive 5 gr. vaginal cream of methanol extract the M.communis 1% for 5 days. Symptoms and vaginal cultures at 2 weeks and 8 weeks after treatment were examined.
General information
Acronym
VVC
IRCT registration information
IRCT registration number:IRCT2013012312250N1
Registration date:2013-03-07, 1391/12/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-07, 1391/12/17
Registrant information
Name
Fahimeh Yousefinezhad
Name of organization / entity
Islamic Azad Unversity, Branch Dezful
Country
Iran (Islamic Republic of)
Phone
+98 64 1626 2417
Email address
yousefi@iaud.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University of Medical Sciences
Expected recruitment start date
2006-02-03, 1384/11/14
Expected recruitment end date
2007-03-08, 1385/12/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of methanol extract of Myrtus communis and clotrimazole on treatment of vaginal candidiasis
Public title
Efficacy of medical plants on Vaginitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Aged 20-30 years; clinical signs and symptoms of Candida vaginitis, pH vaginal (4-4.5) wet smear and culture positive. Exclusion criteria: Pregnant and lactating women; who have multiple sexual partners; diabetes; women with history of chronic Vulvar vaginal Candidiasis (at least 4 times in one year); use of immunosuppressive drugs; current use of oral combined contraceptive pills (OCPs); use of vaginal or oral anti-fungal in a month later and exposure of other Vaginitis.
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
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
Ahvaz University of Medical Sciences
Street address
Golestan High way
City
Ahvaz
Postal code
1579461357
Approval date
2005-06-05, 1384/03/15
Ethics committee reference number
84u84
Health conditions studied
1
Description of health condition studied
Vulvovaginal candidiasis
ICD-10 code
n77
ICD-10 code description
Vulvovaginal ulceration and inflammation in diseases classified elsewhere
Primary outcomes
1
Description
Pruritus
Timepoint
Before treatment , 2 and 8 weeks after treatment
Method of measurement
Vsual Analog Scale for severty symptom
2
Description
Vaginal discharge
Timepoint
Before treatment , 2 and 8 weeks after treatment
Method of measurement
Visual Analog Scale for severty symptom-wet smear-culture
3
Description
Vulvar Erythematic
Timepoint
Before treatment , 2 and 8 weeks after treatment
Method of measurement
Visual Analog Scale for severty symptom-wet smear-culture
4
Description
dysuria
Timepoint
Before treatment , 2 and 8 weeks after treatment
Method of measurement
Visual Analog Scale for severty symptom
5
Description
Vulvar Edema
Timepoint
Beftore treatment , 2 and 8 weeks after treatment
Method of measurement
Visual Analog Scale for severty symptom-wet test and cultuer
6
Description
Disparonia
Timepoint
Before treatment, 2 and 8 weeks after treatment
Method of measurement
Visual Analog Scale for severty symptom
Secondary outcomes
empty
Intervention groups
1
Description
In intervation gruop:Cream vaginal 1%of Myrtus commuins methanol extract was administered an applicator (5 gr) for five consecutive nights
Category
Treatment - Drugs
2
Description
in control group: vaginal cream of clotrimazole1% was administered an applicator (5 gr) for five consecutive nights
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center no. 1
Full name of responsible person
Street address
Enghlab st.
City
Dezful
2
Recruitment center
Name of recruitment center
Health center no. 3
Full name of responsible person
Street address
Komial St.
City
Dezful
3
Recruitment center
Name of recruitment center
Health center no. 5
Full name of responsible person
Ghazi Blvd.
Street address
City
Dezful
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Asadi Zaker Marziyeh
Street address
Nursing and midwifery school of Ahvaz University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University Medical sciences
Full name of responsible person
Poorandokht Afshary
Position
master degree
Other areas of specialty/work
Street address
Nursing and Midwifery faculty
City
Ahvaz
Postal code
Phone
+98 61 1336 7544
Fax
Email
f_afshary@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Dezful Branch
Full name of responsible person
Fahimeh Yousefinezhad
Position
Master Degree
Other areas of specialty/work
Street address
213, Mesam st.
City
Dezful
Postal code
6461975591
Phone
+98 54 1222 5220
Fax
Email
f_yousefynezhad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Dezful Branch
Full name of responsible person
Fahimeh Yousefi nezhad
Position
Master Degree
Other areas of specialty/work
Street address
213, Mesam st.
City
Dezful
Postal code
6461975591
Phone
+98 64 1222 6220
Fax
Email
f_yousefynezhad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)