objective: comparing the effect of Anethum graveolens L. (Dill) vaginal cream with clotrimazole vaginal cream 1%(standard treatment) on vaginal candidiasis. Study Design: clinical trial; randomized (Blocked randomization); double-blind ( creams with the same colour and tubes); single center. Study population: married women; Age group: between 18 to 65 years old; sample size: 105 patients. The main inclusion criteria: sign and symptoms of vulvovaginal candidiasis; with positive sniff test; and without complicated vaginal candidiasis on diagnosis of gynecologist. The main exclusion criteria: side effects or drug reaction. intervention: after vaginal candidiasis confirmation by sniff test, patient divided into 3 groups: 1)Essential oil of Anethum graveolens L. (Dill) vaginal cream (2%) and 2)standard treatment( clotrimazole vaginal cream (1%)) and 3) total extract of dill vaginal cream, and each patient use 1 applicator of vaginal cream a night. intervention time: 1 week. Physical examination, self report and vaginal smear measured before and 3 days after the end of interventions, will be compared in groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071929004N1
Registration date:2016-10-12, 1395/07/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-12, 1395/07/21
Registrant information
Name
Zohreh Sarhadinejhad
Name of organization / entity
Kerman University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5720
Email address
z_sarhadinejhad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman University of Medical Sciences.
Expected recruitment start date
2016-07-14, 1395/04/24
Expected recruitment end date
2017-03-14, 1395/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparision effect of Anethum graveolens L. (dill) products on traditional medicine base with clotrimazole cream 1% on vaginal candidiasis.
Public title
The effect of dill vaginal cream on treatment of candida vaginitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: sign and symptoms of vulvovaginal candidiasis; married women; between 18 to 65 years old; with positive sniff test; without pregnancy, without breast feeding, without chronic disease such as (kidney ,liver, cardiac disease and diabetes ), no existance of immunodeficiency nor complicated vaginal candidiasis on diagnosis of gynecologist and not using of systemic antibiotics and immunosuppressive drugs, or any vaginal drugs during the study and not using of systemic anti fungal drugs since 4 weeks ago.
Exclusion criteria: side effects or drug reaction; pregnancy; menstruate; lack of patient's association.
Age
From 18 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomised(Blocked randomization), case control,double blind , study in single field and control with standard treatment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Kerman University Of Medical Sciences
Street address
Kerman University Of Medical Sciences Paradise, Haftbagh freeway.
City
kerman
Postal code
Approval date
2016-07-13, 1395/04/23
Ethics committee reference number
IR.KMU.AH.REC.1395.15
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
burning
Timepoint
at the beginning and 10 days after intervention
Method of measurement
Evaluation of clinical symptom's remission(burning) with VSQ (vulvovaginal symptom questionnaire)
2
Description
itching
Timepoint
at the beginning and 10 days after intervention
Method of measurement
Evauation of clinical symptom's remission (itching) with VSQ (vulvovaginal symptom questionnaire)
3
Description
vaginal discharge
Timepoint
at the beginning and 10 days after intervention
Method of measurement
Evaluation of clinical symptom's remission (vaginal discharge) with VSQ (vulvovaginal symptom questionnaire)
4
Description
Erithema
Timepoint
at the beginning and 10 days after intervention
Method of measurement
physical exam
5
Description
Edema
Timepoint
at the beginning and 10 days after intervention
Method of measurement
physical exam
Secondary outcomes
1
Description
sniff test outcome
Timepoint
at the beginning and 10 days after intervention
Method of measurement
vaginal smear
Intervention groups
1
Description
using one applicator of Essential oil of Anethum graveolens L. (Dill) vaginal cream (2%) every night for 7 nights.
Category
Treatment - Drugs
2
Description
using one applicator of Clotrimazole vaginal cream 1% every night for 7 nights .
Category
Treatment - Drugs
3
Description
using one applicator of total extract of dill vaginal cream (2%) every night for 7 nights .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology Clinic, Afzalipoor Hospital.
Full name of responsible person
Dr Zohreh Salari
Street address
Afzalipoor Hospital, Emam freeway
City
kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University Of Medical Sciences
Full name of responsible person
Kerman University Of Medical Sciences
Street address
Haftbagh freeway, Kerman University of Medical Sciences Paradise.
City
Kerman
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, Kerman University Of Medical Sciences