Objective: Determine Effect Of Vaginal Cream Glycyrrihiza Glabra On Improvement Of Symptoms Of Fungal Vulvo vaginitis. (2) Study Design: The sampling will be random and triple blind. This study will be placebo-controlled and single center. (3)How do : After receiving permission of ethics Committee, Research consul, and health affairs of Alborz University the researcher will attend at the selected health centers of Karaj city. A written informed consent will be obtained from the participants. Eligible women based on(4) including and excluding criteria will be selected. (5)intervention: Upon selection, they will be clinically examined and vaginal smears will be obtained. The smears will be sent to the laboratory for final diagnosis. Women with positive smear result will be allocated into two groups by random allocation. Group A will be treated with Clotrimazole vaginal cream as standard treatment and group B will be treated with vaginal cream licorice as (intervention group). Creams will be prepared in same shape, size, and color with symbols A or B in Shahid Beheshti University Laboratory. Eligible Participants will receive numbers 1-60 and will be randomly assigned in two groups with Microsoft Excel software (group A and B). Each subject will receive one of the creams and will use one applicator of the cream for 7 consecutive nights. The subjects are asked to contact with the researcher in case of side effects. The subjects are asked to attend at the health center for Checking Signs and symptoms (itching, cheesy secretion, painful intercourse, and dysuria, abnormal cervix) on day 7 . ((6)Main outcome variables)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017031133008N1
Registration date:2017-04-03, 1396/01/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-04-03, 1396/01/14
Registrant information
Name
Neda Dodange Bala Khani
Name of organization / entity
Iran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 2885
Email address
neda.dod@gmail.com
Recruitment status
Recruitment complete
Funding source
Iran university of medical sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-08-06, 1396/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect Of Vaginal Cream Glycyrrihiza Glabra On Improvement Of Symptoms Of Fungal Vulvovaginitis
Public title
Effect Of Vaginal Cream Glycyrrihiza Glabra On Improvement Of Symptoms Of Fungal Vulvovaginitis
Purpose
Treatment
Inclusion/Exclusion criteria
Including criteria consisted of: Women at reproductive age of 15 to 45 years old ؛. married ؛. not being pregnant, menopause, and breast feeding ؛. having at least two symptoms of vaginal candidiasis in interview( observed and being confirmed by laboratory studies) ؛. Lack of chronic diseases such as disorders that weaken the immune system, blood pressure, and diabetes ؛. no use of Chemical and herbal antifungal drugs during the last two weeks ؛. not having other vaginal infection such as trichomonas vaginitis, bacterial and mixtures ؛. not using vaginal creams and suppositories during the 48 hours before starting of the study ؛. not participating in another research study, simultaneously with this study ؛. lack of allergy to licorice ؛. lack of use of broad-spectrum antibiotics and corticosteroids during the last two weeks for any medical proposes .
Exclusion criteria consisted of: getting pregnant during the study ؛. allergy to licorice ؛. obligation to use of antibiotics for treatment of systemic infections other than vaginitis during the study ؛. Failure to adhere to the correct pattern of the treatment (forgetting the drug for more than one night).
Age
From 15 years old to 49 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)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
School of Nursing and Midwifery, Yasemi Rashid Street, Valiasr Street, Tehran