This study is a triple blind cilinical trial and randomized has conducted with the purpose of determination and comparison of the effect of honey vaginal cream and combination of honey and yoghurt vaginal cream for the treatment of vulvovaginal candidiasis in women whom referred to sari health medical center. In this cilinical trial,105 women with known candidiasis will be randomly allocated into three groups. Each group will be 35 person. Drugs consist of: combination of honey and yoghurt , honey and clotrimazole vaginal creams . To hide the allocation, the creams will be prepared in Armaghan teb pharmacy laboratory medicine of tehran and they will be put in quit similar packages and will be available to researcher with codes A,B,C . Data collection was accomplished demographic information questionnaire and clinical performance checklist. Patients will be randomly allocated in groups A,B,C and each group will receive a vaginal cream with the same code similar to the group. The creams are using intra vaginal one applicator every night for 7 nights. They will be recommended to comply with health issues and do not use douching, other vaginal drugs and also herbal and systemic drugs during study period. We will ask participants to come back 7 days and 14 days after initiation of treatment for evaluation of treatment and relapse, respectively. The infection diagnosis and evaluation of treatment and relapse will be based on clinical symptoms, assessment of vaginal pH, direct observation and culture .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201401052248N14
Registration date:2014-06-24, 1393/04/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-24, 1393/04/03
Registrant information
Name
Fereshteh Jahdi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982188773073,00982182471404
Email address
f.jahdi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences"
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2014-06-15, 1393/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of honey vaginal cream and combination of honey and yoghurt vaginal cream for the treatment of vulvovaginal candidiasis
Public title
Effect of yogurt and honey in the treatment of vulvovaginal candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women were married and aged between 18-45 years old; Not being pregnancy, lactation and menopausal period; Not having any vaginal bleeding; No history of allergy to honey ;Not using antifungal drugs for 2 weeks before the study; Not using vaginal cream for last 48 hours before the study; Not using antibiotic and corticosteroids in the past two weeks; Patient with vaginal candidiasis.
Exclusion criteria: Existance of other vaginal infections; Pregnancy in the study time table; Having any known choronic disease; Participation at another trial; Drugs intolerance.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical commitment of Tehran University of Medical Sciences