The comparison of Alum vaginal solution and Clotrimazole vaginal cream in treatment vulvovaginal candidiasis
Design
A randomized, controlled clinical trial with a parallel group design of 72 patients,
Settings and conduct
This study are performed in selected care Center affiliated to Ahvaz JundiShapur University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Being between 18 and 45 years old ؛ Willingness to participate in the study ؛ Being married ،Existence of clinical signs indicating candidiasis vaginitis ؛ Positive wet smear for candida
Exclusion criteria:
Pregnancy ؛ Breastfeeding ؛ Abnormal uterine bleeding ؛ Body mass index equal to or greater than 30 ؛ History of known chronic diseases: diabetes, weakened immune system, epilepsy, hypertension, etc. ؛ History of recurrent candidiasis vulvovaginitis (4 or more than 4 times a year) ؛ Existence of other vaginal infections with candidiasis ؛ Taking oral contraceptive pills ؛ Taking corticosteroids and antibiotics in the last 2 weeks ؛ Taking systemic antifungal drugs in the last 4 weeks ؛ Taking a cream, suppository or vaginal douche in the last 48 hours ؛ History of allergy to clotrimazole
1)Symptoms of vaginal candidiasis (including: pruritus, vaginal soreness, dyspareunia, external dysuria, and abnormal vaginal discharge) and;
2) Signs of vaginal candiasis (Including; vaginal erythema, excoriations, thick white adherent discharge, and swelling).
3) the side defects of the medications after treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200916048736N1
Registration date:2020-11-14, 1399/08/24
Registration timing:prospective
Last update:2020-11-14, 1399/08/24
Update count:0
Registration date
2020-11-14, 1399/08/24
Registrant information
Name
Sorour Soltani hoveizeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3332 5524
Email address
soltani_so@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-15, 1399/08/25
Expected recruitment end date
2021-01-09, 1399/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison effect of Alum and Clotrimazole vaginal cream in treatment vulvovaginal candidiasis.
Public title
The effect of Alum vaginal solution in vaginal candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being between 18 and 45 years old
Willingness to participate in the study
Being married
Existence of clinical signs indicating candidiasis vaginitis
Positive wet smear for candida
Exclusion criteria:
Pregnancy
Breastfeeding
Abnormal uterine bleeding
Body mass index equal to or greater than 30
History of known chronic diseases: diabetes, weakened immune system, epilepsy, hypertension, etc.
History of recurrent candidiasis vulvovaginitis (4 or more than 4 times a year)
Existence of other vaginal infections with candidiasis
Taking oral contraceptive pills
Taking corticosteroids and antibiotics in the last 2 weeks
Taking systemic antifungal drugs in the last 4 weeks
Taking a cream, suppository or vaginal douche in the last 48 hours
History of allergy to clotrimazole
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Participants by method Random blocks are divided into two groups of intervention and control using 6 blocks. The blocks will be provided by Excel software with Rand's formula and the six blocks will be placed in closed envelopes respectively prepared by EXCEL , and the patients will be placed in one of the blocks by opening it.
Blinding (investigator's opinion)
Not 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 Ahvaz Jundishapur University of Medical Sciences
Street address
Ground Floor, Department of Research and Information Technology Jundishapur University of Medical Sciences, City University, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2020-11-01, 1399/08/11
Ethics committee reference number
IR.AJUMS.REC.1399.628
Health conditions studied
1
Description of health condition studied
Vaginal Candidiasis
ICD-10 code
N77.1
ICD-10 code description
Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere
Primary outcomes
1
Description
Symptoms of vaginal candidiasis (including: pruritus, vaginal soreness, dyspareunia, external dysuria, and abnormal vaginal discharge)
Timepoint
Before intervention and 7 days after intervention
Method of measurement
Completing the checklist to assess the symptoms vaginal candidiasis and then comparing the frequency of the Symptoms of vaginal candidiasis within and between two groups of treatment
2
Description
Signs of vaginal candiasis (Including; vaginal erythema, excoriations, thick white adherent discharge)
Timepoint
Before intervention and 7 days after intervention
Method of measurement
Completing the checklist to assess the Signs of Vaginal Candidiasis following vaginal examination and observation. Then comparing the frequency of the signs of vaginal candidiasis within and between two groups of treatment
3
Description
the possible side defects of the medications after treatment
Timepoint
During the intervention and 7 days after the intervention
Method of measurement
Completing the checklist to assess the possible side effects of the medications and then comparing the frequency of the side effects within and between two groups of treatment
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Clotrimazole vaginal cream1%,Pars Daroo Company , one applicator per day for 1 week.
Category
Treatment - Drugs
2
Description
Intervention group: White alum powder is made from perfumery and with a concentration of 13.33% (4 g of alum in 30 cc of distilled water) after autoclaving the solution is packed in 250 cc containers. The subjects will use 10 cc of the solution three times a day for a week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
East's number one health center in Ahvaz
Full name of responsible person
Sorour Soltani
Street address
7 tir park opposite, Ayatollah Behbahani superhighway