Comparison of acetic acid gel with standard treatment on the treatment of patients with vulvovaginal candidiasis
Design
In this double-blinded clinical trial, 74 patients with vulvovaginal candidiasis were assigned into parallel groups using the table of random numbers based on pragmatic and community-based setting.
Settings and conduct
Vulvovaginal candidiasis patients referring to Imam Khomeini Hospital, Sari, Iran, for comparison of acetic acid gel with standard treatment were selected, using double-blinded design. The clinical care provider and data collector were blind to group assignment and the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Reproductive females within the age range of 18-55 years; symptoms of irritation, itching, dysuria, and white as well as cottage cheese-like discharge from vagina; and culture-positive Candida.
Exclusion criteria: Pregnancy; breastfeeding; using immunosuppressive drugs; having sexually transmitted diseases; having diabetes; having allergic to vinegar; the consumption of antibiotics, antifungal agents, or vaginal drugs in the last two weeks; and using other treatment options, such as vaginal douche.
Intervention groups
The intervention group will receive 2% acetic acid gel, intravaginal washing with 2% acetic acid, and Clotrimazole vaginal cream once a day for one week. The control group will receive intravaginal washing with 2% acetic acid and Clotrimazole vaginal cream once a day for one week.
Main outcome variables
Evaluation and comparison of the number of colonies in the culture medium in intervention and control groups after treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190309042978N3
Registration date:2019-05-13, 1398/02/23
Registration timing:prospective
Last update:2019-05-13, 1398/02/23
Update count:0
Registration date
2019-05-13, 1398/02/23
Registrant information
Name
Hamed Jafarpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1700
Email address
h.jafarpour1@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of acetic acid gel with standard treatment on patients with vulvovaginal candidiasis: A clinical trial
Public title
The effect of acetic acid gel on patients with vulvovaginal candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Reproductive females within the age range of 18-55 years
Symptoms of irritation, itching, dysuria, and white as well as cottage cheese-like discharge from vagina
Culture-positive Candida
Exclusion criteria:
Pregnancy
Breastfeeding
Using immunosuppressive drugs
Having diabetes
Having allergic to vinegar
The consumption of antibiotics, antifungal agents, or vaginal drugs in the last two weeks
Having sexually transmitted diseases
Using other treatment options, such as vaginal douche
Age
From 18 years old to 55 years old
Gender
Female
Phase
2
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Totally, 74 patients with vulvovaginal candidiasis referring to Imam Khomeini Hospital, Sari, Iran, were selected in this trial .The participants were assigned into intervention and control groups using the table of random numbers through a computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Vulvovaginal candidiasis patients referring to Imam Khomeini Hospital, Sari, Iran, were selected using double-blinded design. The clinical care provider and data collector were blind to group assignment and the type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Vice Chancellor for Research, Mazandaran University of Medical Sciences, Farah Abad Road
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2018-06-28, 1397/04/07
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1397.1349
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
The number of colonies
Timepoint
Before and after treatment
Method of measurement
Culture medium
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will receive 2% acetic acid gel, intravaginal washing with 2% acetic acid, and Clotrimazole vaginal cream once a day for one week.
Category
Treatment - Drugs
2
Description
Control group: The control group will receive intravaginal washing with 2% acetic acid and Clotrimazole vaginal cream once a day for one week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Zahra Rahmani
Street address
Imam Khomeini Hospital, Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
h.jafarpour@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Saeidi
Street address
Vice Chancellor for Research, Mazandaran University of Medical Sciences, Farah Abad Road
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3335 2725
Email
Admission@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zahra Rahmani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Hospital, Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
h.jafarpour@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zahra Rahmani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Hospital, Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
h.jafarpour@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hamed Jafarpour
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
Imam Khomeini Hospital, Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
h.jafarpour@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcome or the like can be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working at science centers and universities
Under which criteria data/document could be used
Our data will be available for scholars working at science centers and universities
From where data/document is obtainable
Hamed Jafarpour provides the data analysis to the applicants via email: h.jafarpour@mazums.ac.ir
What processes are involved for a request to access data/document
Applicants can respond to the email of the respondent and receive a response within a week.