Comparing the effects of Mycozin and Clotrimazole 1% on vaginal candidiasis
Design
A triple-blind clinical trial, phase 3 on 126 patients. Randomization will done using Random Allocation Software (RAS) through blocked randomization method.
Settings and conduct
This research is a triple-blind randomized clinical trial (participant, researcher, outcome assessor and data analyst will be blinded) with the aim of comparing the effect of mycozin with clotrimazole 1% vaginal cream on the treatment of vaginal candidiasis will be done in married women aged 18-45 years old referring to the Al-Zahra educational-therapeutic hospital in Tabriz city.
Participants/Inclusion and exclusion criteria
Inclusion criteria:18-45 years; married; having reading and writing literacy; lackof allergy to herbal medicines and compounds containing azole; suffering from Candida vaginitis
Exclusion criteria: Suffering from chronic diseases; taking antibiotics, corticosteroids and oral contraceptives; menstruation at the time of study; having a wound or mass in the cervix; having severe mental stress during the last three months; pregnancy or breastfeeding at the time of the study; taking other drugs to treat vaginitis; having recurrent vulvovaginitis; abnormal uterine bleeding.
Intervention groups
Intervention group 1 will use Mycozin vaginal cream at bedtime for one week.
Intervention group 2 will use Clotrimazole 1% vaginal cream at bedtime for one week.
Main outcome variables
Negative culture in terms of vaginal candidiasis; Signs and symptoms of vaginal candidiasis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120718010324N77
Registration date:2023-05-20, 1402/02/30
Registration timing:prospective
Last update:2023-05-20, 1402/02/30
Update count:0
Registration date
2023-05-20, 1402/02/30
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-31, 1402/03/10
Expected recruitment end date
2023-11-01, 1402/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effects of Mycozin and Clotrimazole 1% on Vaginal Candidiasis: a Triple Blinded Randomized Controlled Trial
Public title
Comparing the Effects of Mycozin and Clotrimazole on Vaginal Candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-45 years
married
Being literate in reading and writing
Lack of allergy to herbal medicines
Suffering from candidal vaginitis
Exclusion criteria:
Suffering from chronic diseases such as diabetes, AIDS, immune system disorders, depression, etc. currently, according to the participant's statement
Taking antibiotics and corticosteroids during the last two weeks according to the participant's statement
Menstruation at the time of study
Current use of oral contraceptives as reported by the participant
The presence of a wound or mass in the cervix when viewed with a speculum
Existence of severe mental stress during the last three months, such as the death of first-degree relatives
Presence of pregnancy or breastfeeding at the time of study
Taking other drugs to treat vaginitis
Having recurrent vulvovaginitis (more than four times per year)
Abnormal uterine bleeding
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be allocated randomly into two groups receiving mycosin vaginal cream and clotrimazole vaginal cream 1% using Random Allocation Software (RAS) through four and six blocks and with a ratio of 1:1 (40 people in each group) . The type of allocation will be written on paper and placed in consecutively numbered opaque envelopes (Allocation Concealment). The envelopes will be opened in order by a person not involved in sampling.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participants, researcher and data analyst will be blinded completely in this study. Mycozin and Clotrimazole will be similar in appearance (shape, color, smell) and packaging of drug and placebo will be conducted by a person not involved in the research.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2023-05-08, 1402/02/18
Ethics committee reference number
IR.TBZMED.REC.1402.112
Health conditions studied
1
Description of health condition studied
Vaginal Candidiasis
ICD-10 code
B37.3
ICD-10 code description
Candidiasis of vulva and vagina
Primary outcomes
1
Description
frequency of clinical symptoms (smell, quantity, consistency, color and appearance of vaginal secretions, vaginal inflammation, appearance of cervix)
Timepoint
Before the intervention and 10 to 15 days after the intervention
Method of measurement
Clinical examination by the researcher and clinical symptoms checklist
2
Description
Frequency of patient complaints (secretions, dysuria, frequency, itching, itching during intercourse, pain in the lower abdomen, burning sensation during intercourse, and dyspareunia)
Timepoint
Before the intervention and 10 to 15 days after the intervention
Method of measurement
Stated by the participants and complaints checklist
3
Description
Frequency of laboratory symptoms (negative smear and culture of vaginal secretions)
Timepoint
Before the intervention and 10 to 15 days after the intervention
Method of measurement
Sampling will be done with a sterile cotton swab from the posterior fornix of the vagina, and we will dip the swab inside the blood culture tubes and gently shake it inside the solution until the sample dissolves in it. Incubation will be at 37 degrees for 2 to 4 hours, and a drop of the contents of the tube solution will be transferred on a slide. We examine the slide under the microscope with high and low magnification. Germ tube formation test is a quick test to identify Candida albicans and differentiate it from other yeasts.
Secondary outcomes
1
Description
PH of vaginal secretions
Timepoint
Before the intervention and 10 to 15 days after the intervention
Method of measurement
PH paper
2
Description
Satisfaction with the treatment
Timepoint
10 to 15 days after the intervention
Method of measurement
Satisfaction questionnaire
3
Description
Side events
Timepoint
10 to 15 days after the intervention
Method of measurement
Side events checklist
Intervention groups
1
Description
Intervention group 1 will use Mycozin vaginal cream at bedtime for one week.
Category
Treatment - Drugs
2
Description
Intervention group 2 will use Clotrimazole 1% vaginal cream at bedtime for one week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra educational hospital
Full name of responsible person
Mojgan Mirghafourvand
Street address
Alzahra hospital, Baghshomal Square
City
Tabriz
Province
East Azarbaijan
Postal code
6579351386
Phone
+98 41 3553 9161
Email
nursing@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Parviz Shahabi
Street address
Research department, third floor, central construction number2, Tabriz university of medical sciences, Golghasht street, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6969
Email
dabirkhancent@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Khadijeh Hajizadeh
Position
Instructor of Tabriz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3475 1708
Email
hajizade_k@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mojgan Mirghafourvand
Position
Professor of Tabriz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3475 1708
Email
mirghafourvand@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mojgan Mirghafourvand
Position
Professor of Tabriz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
0098347501708
Fax
Email
mirghafourvand@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available