Comparison the effect of Origanum vulgare vaginal cream with clotrimazole vaginal cream on treatment of vulvovaginal candidiasis in reproductive aged women
The aim of the present clinical trial is to compare the effectiveness of Origanum vulgare vaginal cream with clotrimazole vaginal cream on the treatment of vulvovaginal candidiasis.
Design
A phase 3 randomized clinical trial with a control group, parallel groups, triple-blind design, conducted on 98 patients. Randomization will be performed using permuted random blocks of sizes 4, 6, and 8, utilizing the website www.randomization.com.
Settings and conduct
This study will be a triple-blind, randomized controlled clinical trial conducted on 98 eligible women with vulvovaginal candidiasis who visit the specialized gynecology and obstetrics clinics affiliated with Ahvaz University of Medical Sciences. Participants will be randomly assigned to two groups, control and intervention using permuted block randomization with block sizes of 4, 6, and 8.
Participants/Inclusion and exclusion criteria
In this study, women aged 18 to 45 years with clinical symptoms of vulvovaginal candidiasis, positive results from direct microscopy and culture of vaginal discharge tests and no known sensitivity to Origanum vulgare or clotrimazole will be included.
Pregnant and breastfeeding women, those with abnormal vaginal bleeding, known chronic diseases such as diabetes, hypertension and etc., recent use of broad-spectrum antibiotics or oral/vaginal medications related to genital infections within the past two weeks will be excluded from the study.
Intervention groups
Intervention group: Origanum vulgare vaginal cream 1% (each night, one full applicator containing 5gr of vaginal cream will be used for a duration of one week)
Control group: clotrimazole vaginal cream 1% (each night, one full applicator containing 5gr of vaginal cream will be used for a duration of one week)
Main outcome variables
Result of direct microscopic and culture of vaginal discharge test and clinical symptoms of vulvovaginal candidiasis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241221064119N1
Registration date:2024-12-25, 1403/10/05
Registration timing:prospective
Last update:2024-12-25, 1403/10/05
Update count:4
Registration date
2024-12-25, 1403/10/05
Registrant information
Name
Fatemeh Shahriari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5283 6521
Email address
shahriari.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-08, 1403/11/20
Expected recruitment end date
2025-05-10, 1404/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Origanum vulgare vaginal cream with clotrimazole vaginal cream on treatment of vulvovaginal candidiasis in reproductive aged women
Public title
Investigation the effect of Origanum vulgare vaginal cream on treatment of vulvovaginal candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being married
Being monogamous
The presence of clinical symptoms indicative of vulvovaginal candidiasis
Positive result of the direct microscopy test of vaginal discharge
Positive result of the vaginal discharge culture test
No history of any known medical condition
No allergy to Origanum vulgare plant and clotrimazole
Completion of a written informed consent form
Exclusion criteria:
Pregnancy
Breastfeeding
Menopause
Abnormal vaginal bleeding
Body mass index (BMI) ≥ 30
History of recurrent vulvovaginal candidiasis infections (4 or more episodes per year)
History of known chronic diseases such as diabetes, hypertension, heart disease, immune system disorders and epilepsy
Use of broad-spectrum antibiotics within the past two weeks
Use of immunosuppressive drugs, corticosteroids or contraceptive pills
Use of oral or vaginal medications related to genital infections within the past two weeks
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the method of permuted block randomization to randomly assign participants to the intervention and control groups. The block sizes in this two-group clinical trial will be set at 4, 6, and 8 (in this method, the number of participants assigned to each group within a block is equal). To ensure allocation concealment, we will use random allocation concealment, which refers to the method used to implement the random sequence for participants in the study, such that the assigned group is not known before allocation. In this study, 1% clotrimazole vaginal cream, under sterile conditions, will be filled into tubes identical to those used for Origanum vulgare vaginal cream. These medications will be labeled as A and B by a pharmacist. Thus, the clotrimazole and Origanum vulgare vaginal creams will be identical in appearance, such as packaging and color, ensuring that neither the researcher nor the patient is aware of the type of vaginal cream being administered. The medications used in this study will be placed in sealed envelopes and assigned to each participant according to the randomized list by an individual not involved in the study.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study will be conducted in a triple-blind manner, meaning that the researcher, the study participants, and the data analyst (statistician) will all be completely unaware of the type of vaginal medication being used by the participants. Clotrimazole and oregano cream will be dispensed into identical tubes and labeled as A and B by the pharmacist. Thus, the clotrimazole and oregano vaginal creams will be identical in appearance, including packaging and color. The medications used in this study will be placed in sealed envelopes and assigned to each participant according to a randomized list prepared by an individual outside the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Ahvaz Jundishapur University of Medical Sciences and health services
Street address
Ahvaz, Golestan Blvd., Ahvaz Jundishapur University of Medical Sciences and health services
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2024-12-07, 1403/09/17
Ethics committee reference number
IR.AJUMS.REC.1403.492
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
Vulvovaginal itching
Timepoint
Before the intervention and one week after completing the treatment course
Method of measurement
Taking the patient's history
2
Description
Vulvovaginal erythema
Timepoint
Before the intervention and one week after completing the treatment course
Method of measurement
Clinical examination
3
Description
Vulvovaginal burning
Timepoint
Before the intervention and one week after completing the treatment course
Method of measurement
Taking the patient's history
4
Description
Vaginal discharge
Timepoint
Before the intervention and one week after completing the treatment course
Method of measurement
Taking the patient's history and clinical examination
5
Description
Vaginal pH
Timepoint
Before the intervention and one week after completing the treatment course
Method of measurement
pH indicator strips
6
Description
Gram staining of vaginal discharge smear test
Timepoint
Before the intervention and one week after completing the treatment course
Method of measurement
Gram staining of vaginal discharge smear
7
Description
Vaginal discharge culture
Timepoint
Before the intervention and one week after completing the treatment course
Method of measurement
Vaginal discharge culture on CHROMagar candida medium
8
Description
Complete recovery from vulvovaginal candidiasis
Timepoint
Before the intervention and one week after completing the treatment course
Method of measurement
Taking the patient's history, clinical examination, Gram staining of vaginal discharge smear and vaginal discharge culture on CHROMagar candida medium
Secondary outcomes
1
Description
Urinary burning
Timepoint
Before the intervention and one week after completing the treatment course
Method of measurement
Taking the patient's medical history
2
Description
Dyspareunia
Timepoint
Before the intervention and one week after completing the treatment course
Method of measurement
Taking the patient's medical history
3
Description
Side effects
Timepoint
Before the intervention and one week after completing the treatment course
Method of measurement
Taking the patient's medical history
Intervention groups
1
Description
Intervention Group: In the intervention group, when administering the medication, patients will be provided with necessary hygiene instructions. These instructions include: wearing cotton underwear and changing it regularly (at least every 1–2 days), washing the perineum from front to back and drying it after washing, washing hands before and after using the medication, and washing the applicator with lukewarm water and soap. All participants in the intervention group will be instructed to use one full applicator (5gr) of 1% Origanum vulgare vaginal cream every night for one week. They will also be advised to refrain from using other vaginal medications, antibiotics, or engaging in unprotected intercourse during the treatment period. Finally, patients will be asked to visit the clinic for post-treatment follow-up 7 days after completing the treatment course.
Category
Treatment - Drugs
2
Description
Control group: In the control group, when administering the medication, patients will be provided with necessary hygiene instructions. These instructions include: wearing cotton underwear and changing it regularly (at least every 1–2 days), washing the perineum from front to back and drying it after washing, washing hands before and after using the medication, and washing the applicator with lukewarm water and soap. All participants in the control group will be instructed to use one full applicator (5gr) of 1% clotrimazole vaginal cream every night for one week. They will also be advised to refrain from using other vaginal medications, antibiotics, or engaging in unprotected intercourse during the treatment period. Finally, patients will be asked to visit the clinic for post-treatment follow-up 7 days after completing the treatment course.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized and sub-specialized gynecology and obstetrics clinics of the affiliated hospitals of Ahv
Full name of responsible person
Fatemeh Shahriari
Street address
Ahvaz, Golestan Blvd., Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 916 634 9502
Email
fatemeh.shah9675@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Ahvaz, Golestan Blvd., Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Shahriari
Position
Master's student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Ave., Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 916 634 9502
Email
fatemeh.shah9675@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Solmaz Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Ave., Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3222 2922
Email
sl.mohammadi89@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Shahriari
Position
Master's student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Ave., Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 916 634 9502
Email
fatemeh.shah9675@gmail.com
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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be available for publication after the completion of the thesis and the publication of the article.
When the data will become available and for how long
One week after the completion of the thesis and the publication of the article.
To whom data/document is available
Ahvaz Jundishapur University of Medical Sciences and all researchers in hospitals, clinics and universities.
Under which criteria data/document could be used
The data will be accessible to others after analysis, through publication in scientific research journals.