To compare the effect of Chamelin Ahoora Daroo vaginal cream (chamomile extract )and clotrimazol vaginal cream in the treatment of Vulvovaginal Candidiasis
This study is designed to evaluate the effect o f Chamomile (Ahoora Daroo) vaginal cream for the treatment of Vulvovaginal Candidiasis; and to compare this effect with the effect of clotrimazole vaginal cream.
ََAt first women who visit in the out patient clinic of Shiraz University of Medical Sciences, who are in reproductive age and have complain of Vulvovaginal
itching and are without history of previous systemic disease are examined; then the possibility of Vulvovaginal Candidiasis is confirmed with, PH meter and microscopic finding. After that, a Code is given to the patients by the examiner using the random numbers table and they go to the pharmacy, and will receive their medication. Two weeks after applying the cream(10 nights) the pt will exam. The signs and symptoms of the disease will recheck (microscopic and acidity) and the result will compar by the statistical analysis. this study is triple blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051118655N2
Registration date:2016-10-13, 1395/07/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-13, 1395/07/22
Registrant information
Name
Tahereh Poordast
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 2365
Email address
poordast@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To compare the effect of Chamelin Ahoora Daroo vaginal cream (chamomile extract )and clotrimazol vaginal cream in the treatment of Vulvovaginal Candidiasis
Public title
Evaluating the effect of Chamomelin vaginal cream on the management of Vulvovaginal Candidiasis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women in reproductive age; with diagnosis of Vulvovaginal
Candidiasis
exclusion criteria: menopause; systemic disease; applying vaginal cream during the previous week .
Age
From 20 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shiraz univercity of medical sciences
Street address
Zand street Namazi square
City
Shiraz
Postal code
Approval date
2015-02-08, 1393/11/19
Ethics committee reference number
IR.SUMS.REC ct-p-9386-8186
Health conditions studied
1
Description of health condition studied
Vulvovaginal Candidiasis
ICD-10 code
B37.3+
ICD-10 code description
Candidiasis of Vulva and Vagina
Primary outcomes
1
Description
Microscopic evaluation of the hypha in Vaginal secretion
Timepoint
Befor treatment and one week (ten nights) after applying the cream
Method of measurement
Count the hypha in each field
2
Description
Check the acidity of Vagina
Timepoint
Befor and during one week after treatment
Method of measurement
PH meter
Secondary outcomes
1
Description
Signs and symptoms of Vulvovaginal Candidiasis
Timepoint
Before treatment and one week after ten nights applying the medication
Method of measurement
Evaluate the improvement and severity of signs and symptoms
Intervention groups
1
Description
case: Chamomeline Ahooradaroo Vaginal cream one applicator for ten nights
Category
Treatment - Drugs
2
Description
control group: Clotrimazol Vaginal Cream one applicator for ten nights
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Dr Tahereh Poordast faculty of OB&GYN
Street address
Zand Street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz Univercity of Medical Sciences-infertility research center
Full name of responsible person
Dr Bahia Namavar Jahromi
Street address
Zand street Namazi square Ghadir child and mother research center
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz Univercity of Medical Sciences-infertility 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
Shiraz Univercity of Medical Sciences
Full name of responsible person
Tahereh Poordast
Position
Faculty member of OB&GYN ward
Other areas of specialty/work
Street address
Faghihi hospital
City
Shiraz
Postal code
Phone
+98 71 3233 2365
Fax
+98 71 3233 2365
Email
ta.poordast@yahoo.com ؛ poordast@sums.ac.ir
Web page address
www.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Infertility research center ,department of obstetrics and gynecology ,school of medicine,shiraz univ
Full name of responsible person
Taherh poordast
Position
Board of OB&GYN
Other areas of specialty/work
Street address
Faghihi hospital ,Department of OB&GYN
City
Shiraz
Postal code
Phone
+98 71 3233 2365
Fax
+98 71 3233 2365
Email
ta.poordast@yahoo.com ؛ poordast@sums.ac.ir
Web page address
www.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz Univercity of Medical Sciences
Full name of responsible person
Tahereh Poordast
Position
Faculty of OB&GYN ward
Other areas of specialty/work
Street address
Faghihi hospital
City
Shiraz
Postal code
Phone
+98 71 3233 2365
Fax
+98 71 3233 2365
Email
ta,poordast@yahoo.com ; poordast@sums.ac.ir
Web page address
www.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)