Effect of vaginal suppositories containing essential oil of Zataria Multiflora versus Leucorex cream on clinical symptoms in patients with candida vaginitis: a randomized clinical trial
To assess the effect of vaginal suppositories containing essential oil of Zataria Multiflora versus Leucorex cream on clinical symptoms in patients with candida vaginitis
Design
This is a randomized clinical trial with control group, phase III, in which eligible patients will be randomly assigned through the drawing of lots to the intervention and control groups
Settings and conduct
This study will be performed in the Comprehensive Health Centers on 80 eligible patients. The patients will be randomly assigned to the intervention and control groups through the drawing of lots. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 44 years;
Candida vaginitis;
Exclusion criteria:
Pregnancy or breastfeeding;
Taking any antiparasitic drugs, antibiotics, or immunosuppressive drugs in the past two weeks;
Abnormal uterine bleeding;
Alcohol consumption;
Chronic diseases including liver failure, diseases of the central nervous system, dyskrasias, diabetes, immune deficiency
Intervention groups
Intervention group:
Using vaginal suppositories containing essential oil of Zataria Multiflora every night for one week
Control group:
Using Leucorex cream 50 mg every night for one week
Main outcome variables
Primary outcome:
Signs and symptoms of candida vaginitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N420
Registration date:2022-03-16, 1400/12/25
Registration timing:registered_while_recruiting
Last update:2022-03-16, 1400/12/25
Update count:0
Registration date
2022-03-16, 1400/12/25
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-16, 1400/12/25
Expected recruitment end date
2022-05-21, 1401/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vaginal suppositories containing essential oil of Zataria Multiflora versus Leucorex cream on clinical symptoms in patients with candida vaginitis: a randomized clinical trial
Public title
Effect of vaginal suppositories containing essential oil of Zataria Multiflora versus Leucorex cream on clinical symptoms in patients with candida vaginitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 44 years;
Candida vaginitis;
Exclusion criteria:
Pregnancy or breastfeeding;
Taking any antiparasitic drugs, antibiotics, or immunosuppressive drugs in the past two weeks;
Abnormal uterine bleeding;
Alcohol consumption;
Chronic diseases including liver failure, diseases of the central nervous system, dyskrasias, diabetes, immune deficiency
Age
From 18 years old to 44 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-05-05, 1399/02/16
Ethics committee reference number
IR.UMSHA.REC.1399.078
Health conditions studied
1
Description of health condition studied
candida vaginitis
ICD-10 code
N76.0
ICD-10 code description
Acute vaginitis
Primary outcomes
1
Description
Signs and symptoms of candida vaginitis
Timepoint
Before the intervention and one week after that
Method of measurement
Through taking history and clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Using vaginal suppositories containing essential oil of Zataria Multiflora every night for one week
Category
Treatment - Drugs
2
Description
Control group: Using Leucorex cream 50 mg every night for one week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers in Hamadan city
Full name of responsible person
Neda Safari
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
neda.safari.7596@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Neda Safari
Position
Student of Pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
neda.safari.7596@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Farzin Firozan
Position
Pharmacologist
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
ffirozian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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