Effect of 2% dill (Anethum graveolens L.) vaginal suppositories and clotimazole 100 vaginal suppositories for the treatment of vulvovaginal Candidiasis
Objective: comparing the effect of 2% dill (Anethum graveolens L.) vaginal suppositories and clotimazole 100 vaginal suppositories for the treatment of vulvovaginal Candidiasis. This study was a single-blind, randomized, placebo-controlled trial, single center, in which sixty women with confirmed vulvovaginal candidiasis were selected and then randomly assigned to Anethum graveolens L and clotimazole groups. Patient was assessed clinically and mycology by same gynecology in both first and final visit. Inclusion criteria consisted of married women aged 15- 49 years; have received a clinical diagnosis of vaginal candidiasis; have had a positive culture for vaginal candidiasis. Exclusion criteria: were pregnancy or breast-feeding; received antibiotic drugs and topical and systemic anti-fungal drugs within one month before; had three or more episode of VVC per year; missed more than one suppositories or vaginal tablet uses within seven consecutive days; had hypersensitivity to clotrimazole or Anthum graveolen.
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General information
Acronym
vulvovaginal Candidiasis
IRCT registration information
IRCT registration number:IRCT2016101828789N4
Registration date:2017-03-01, 1395/12/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-01, 1395/12/11
Registrant information
Name
Masumeh Ghazanfarpour
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 4230 9487
Email address
ghazanfarpm901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-11-11, 1394/08/20
Expected recruitment end date
2016-06-28, 1395/04/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 2% dill (Anethum graveolens L.) vaginal suppositories and clotimazole 100 vaginal suppositories for the treatment of vulvovaginal Candidiasis
Public title
Effect of Anthum graveolen on vulvovaginal Candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria consisted of married women aged 15- 49 years; have received a clinical diagnosis of vaginal candidiasis; have had a positive culture for vaginal candidiasis. Exclusion criteria: were pregnancy or breast-feeding; received antibiotic drugs and topical and systemic anti-fungal drugs within one month before; had three or more episode of VVC per year; missed more than one suppositories or vaginal tablet uses within seven consecutive days; had hypersensitivity to clotrimazole or Anthum graveolen.
Age
From 17 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Biomedical research, Mashhad University of Medical Sciences-
Street address
Ghoreishi building Daneshgah street Mashhad Khorasan Razavi Iran, Islamic Republic Of
City
Korsan razavi
Postal code
Approval date
2012-09-07, 1391/06/17
Ethics committee reference number
IR.mums.res.1391.802
Health conditions studied
1
Description of health condition studied
vulvovaginal Candidiasis
ICD-10 code
N77.1
ICD-10 code description
Candidiasis of vulva and vagina
Primary outcomes
1
Description
itching
Timepoint
before intervention and 7 days after intervention
Method of measurement
4-point likert-type scale
2
Description
burning
Timepoint
before intervention and 7 days after intervention
Method of measurement
4-point likert-type scale
3
Description
vaginal discharge
Timepoint
before intervention and 7 days after intervention
Method of measurement
4-point likert-type scale
Secondary outcomes
1
Description
Improve Of Vulvovaginal Candidiasis
Timepoint
before intervention and7 days after intervention
Method of measurement
Microscopic evaluation
Intervention groups
1
Description
one clotrimazole 100 mg vaginal Tablet every night for 7 nights.
Category
Treatment - Drugs
2
Description
one 2% dill (Anethum graveolens L.) vaginal suppositories every night for 7 nights
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology Clinic of Emam Reza Hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences, Vice chancellor for research