The purpose of this randomized double blind study was to determine the effects of Licorice vaginal cream in the treatment of Candida vaginitis. This research is a clinical trial and activity of licorice was investigated in two processes.
First: An Invitro investigated was carried out to determine the antifungal activity to form of vaginal cream
Second: This was an experimentaly randomized double blind study. A total of 65 women complaining of candidia vaginitis symptom were examined using vaginal swab sampling for culture and Gram stain. After confirm candidia vaginitis with culture and dry smear randomaly divided in two groups in which 33 cases recived licorice cream vaginal and 32 women received clotrimazol cream vaginal for 7 day. Patient followuped 1 & 2 week after treatment (carried out dry smear, culture).
The finding indicated the similar effect of vaginal cream licorice and clotrimazol in treatment and relaps of candidiasis vaginitis .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016032511360N2
Registration date:2016-05-03, 1395/02/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-03, 1395/02/14
Registrant information
Name
Mina Iravani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 916 322 2899
Email address
iravani-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Jondishapour University of Medical Sciences
Expected recruitment start date
2008-04-03, 1387/01/15
Expected recruitment end date
2008-09-20, 1387/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of Licorice vaginal cream with Clotrimazol vaginal cream in candida vaginitis treatment
Public title
Comparison of effect of Licorice vaginal cream with Clotrimazol vaginal cream in candida vaginitis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: signs and symptoms of Candida vaginitis, positive direct smear of vaginal discharge Exclusion criteria: pregnant women, low compliance, any drug hypersensitivity, recurrent Candida vaginitis (4 or more Candida vaginitis in a year), consumption of immunosuppressive drug or widespread antibiotics, history of epilepsy, diabetes, heart disease, high blood pressure, thyroid diseases, or advanced arthritis, using other vaginal creams or suppositories during the study period, consumption of systemic antifungal drugs during 4 weeks prior to the study, presence of non-candidal vaginitis, consumption of oral contraceptives.
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized using random numbers generated by the computer
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Researching Deputy of Jondishapour Ahvaz University of Medical Sciences, Ahvaz University City, Khouzestan.
City
Ahvaz
Postal code
61357-15794
Approval date
2008-01-05, 1386/10/15
Ethics committee reference number
u-87053
Health conditions studied
1
Description of health condition studied
Candida Vaginitis
ICD-10 code
B37.3
ICD-10 code description
Candidiasis of Vulva and Vagina
Primary outcomes
1
Description
Discharge
Timepoint
Baseline, 1&2 week after treatment
Method of measurement
Clinical Examination, observation, and medical history
2
Description
Pruritus
Timepoint
Baseline, 1&2 week after treatment
Method of measurement
History
3
Description
Erythema symptoma
Timepoint
Baseline, 1&2 week after treatment
Method of measurement
Clinical Examination, Observation, and History
4
Description
Dysuria Symptom
Timepoint
Baseline, 1&2 week after treatment
Method of measurement
History
5
Description
Dysparonia Symptom
Timepoint
Baseline, 1&2 week after treatment
Method of measurement
History
6
Description
Wet Smear and Vaginal Culture results
Timepoint
Baseline, 1&2 week after treatment
Method of measurement
Wet Smear and Vaginal Culture
Secondary outcomes
empty
Intervention groups
1
Description
Treatment with vaginal cream Licorice 2%- Built in the Pharmacy School of Ahvaz Jundishapur University of Medical Sciences-one applicator every night for a week-Intervention group
Category
Treatment - Drugs
2
Description
Treatment with vaginal cream Clotrimazole 1%- production of Pars darou company-an applicator every night for a week-control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeyni Hospital, Ahvaz
Full name of responsible person
Dr.Mina Iravani
Street address
Imam Khomeyni Hospital, Ahvaz, khouzestan, Iran
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Jondishapour University of Medical Sciences
Full name of responsible person
Dr. Nder Saki
Street address
Researching Deputy of Jondishapour Ahvaz University of Medical Sciences, Ahvaz University City, Khouzestan.
City
Ahvaz
Grant name
u
Grant code / Reference number
87053
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Jondishapour 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
Jondishapour University of Medical Sciences
Full name of responsible person
Dr.Mina Iravani
Position
Ph.D in Reproductive Health and Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Jondishapour University of Medical Sciences, Ahvaz University City, Khouzestan
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
minairavani2004@yahoo.com;iravani-m@ajums.ac.ir
Web page address
vchresearch.ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Jondishapour University of Medical Sciences,
Full name of responsible person
Dr.Mina Iravani
Position
A Member Academic-Associated Profesor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Jondishapour University of Medical Sciences, Ahvaz University City, Khouzestan Ahvaz ,Iran
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
minairavani2004@yahoo.com;iravani-m@ajums.ac.ir
Web page address
vchresearch.ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Jondishapour University of Medical Sciences
Full name of responsible person
Dr.Mina Iravani
Position
A Member Academic-Associated Profesor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Jondishapour University of Medical Sciences, Ahvaz University City, Khouzestan Ahvaz
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
minairavani2004@yahii.com;iravani-m@ajums.ac.ir
Web page address
vchresearch.ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)