This clinical trial will be done following the researcher's previous study on the topic” the invitro evaluation lavender and clotrimazole on Candida albicans”. The inclusion criteria: 15 to 49 years old married women. Exclusion criteria: women that had history of using antibiotic, oral contraceptive pills, any antifungal drugs, for 4 weeks before the study, latescent or pregnant women ,using immunosuppressive drugs, have cervicitis sign and cervix ectropion, Trichomoniasis and bacterial vaginosis, overweight (Body Mass Index>29) and have diabetes. The patients will be examined for candidiasis and rolling out of bacterial vaginosis and the researcher will take vaginal discharge samples from lateral and posterior walls of vagina by cotton soaps and will send them to the laboratory for definite detecting of Candida albicans fungus. The patients will be divided into two groups of intervention (lavender vaginal cream 2%) and control (clotrimazole vaginal cream1%) randomly. The patients will use the drugs for 7 nights in one applicator (5 grams). The patient whose fungi culture was negative in the first sampling or had tricomoniasis will be eliminated in this study. The candida positive patient will be back in 4-7 days after treatment for reexamination and evaluation of the clinical signs and sampling and the next 40 days for the recurrence evaluation and sampling.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902103004N3
Registration date:2010-05-29, 1389/03/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-05-29, 1389/03/08
Registrant information
Name
Fereshteh Behmanesh
Name of organization / entity
Babol university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1322 5585
Email address
midwifery@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol university of medical sciences
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of lavender and clotrimazole in the treatment of vaginal candidiasis (A double blind randomized controlled trial)
Public title
The effect of lavender and clotrimazole in the treatment of vaginal candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 15 to 49 years old married women. Exclusion criteria: women that had history of using antibiotic, oral contraceptive pills, any antifungal drugs, for 4 weeks before the study, latescent or pregnant women ,using immunosuppressive drugs, have cervicitis sign and cervix ectropion, Trichomoniasis and bacterial vaginosis, overweight (Body Mass Index>29) and have diabetes
Age
From 15 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Babol university of medical sciences
Street address
Babol university of medical sciences
City
Babol
Postal code
Approval date
2010-03-10, 1388/12/19
Ethics committee reference number
5796
Health conditions studied
1
Description of health condition studied
candidiasis
ICD-10 code
B37.3+
ICD-10 code description
Candidiasis of vulva and vagina
Primary outcomes
1
Description
Improvement of candidiasis signs
Timepoint
4-7 next days
Method of measurement
Examination & labratory test & questionnaire
Secondary outcomes
1
Description
Recurrence of disease improvment
Timepoint
40 next days
Method of measurement
Examination & labratory test & questionnaire
Intervention groups
1
Description
Intervention group: using one aplicator of lavender vaginal cream 2% every night for 7 nights
Category
Treatment - Drugs
2
Description
Control group: using one aplicator of clotrimazole vaginal cream 1% every night for 7 nights
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Babol university of medical sciences
Full name of responsible person
Dr Mahtab Zeinalzadeh
Street address
Babol university of medical sciences
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol university of medical sciences
Full name of responsible person
Amrola Mostafazadeh
Street address
Babol university of medical sciences chancellor statics and information tecnology
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol university of medical sciences
Full name of responsible person
Fereshteh Behmanesh
Position
Midwifery msc/faculty member
Other areas of specialty/work
Street address
Babol university of medical sciences miwifery group
City
Babol
Postal code
Phone
+98 11 1219 0597
Fax
Email
f24farzan45@gmail.com - f24farzan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol university of medical sciences
Full name of responsible person
Fereshteh Behmanesh
Position
Midwifery msc/faculty member
Other areas of specialty/work
Street address
Babol university of medical sciences midwifery group
City
Babol
Postal code
Phone
+98 11 1219 0597
Fax
Email
f24farzan45@gmail.com - f24farzan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol university of medical sciences
Full name of responsible person
Fereshteh Behmanesh
Position
Midwifery MSC/ Faculty member
Other areas of specialty/work
Street address
Babol university of medical sciences
City
Babol
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)