Comparison of the effect of compound vaginal cream (honey, olive oil and propolis) versus Clotrimazole vaginal cream on candida vaginitis in fertile women: a double-blind randomized clinical trial
Comparison of the effect of compound vaginal cream (honey, olive oil and propolis) versus Clotrimazole vaginal cream on candida vaginitis among fertile women
Design
This is a double-blind randomized clinical trial, phase II, in which 116 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible fertile women who will refer to Health Centers in Hamadan City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician who will examine the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 44 years
Married fertile women
Candida vaginitis
Exclusion criteria:
Current using antifungal, antibiotic, immunosuppressive drugs or OCP
Unusual uterine bleeding
Recurrent Volvo vaginitis
Pregnancy
Breastfeeding
Using alcohol
Intervention groups
Intervention group
Compound vaginal cream (honey, olive oil and propolis) 60 g every night using the intravaginal applicator for 7 days
Control group:
Clotrimazole vaginal cream 1% 5 g every night using the intravaginal applicator for 7 days
Main outcome variables
Primary outcome:
Assessing the vaginal lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N290
Registration date:2019-08-16, 1398/05/25
Registration timing:prospective
Last update:2019-08-16, 1398/05/25
Update count:0
Registration date
2019-08-16, 1398/05/25
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
2019-08-23, 1398/06/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of compound vaginal cream (honey, olive oil and propolis) versus Clotrimazole vaginal cream on candida vaginitis in fertile women: a double-blind randomized clinical trial
Public title
Comparison of the effect of compound vaginal cream (honey, olive oil and propolis) versus Clotrimazole vaginal cream on candida vaginitis in fertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 44 years
Married fertile women
Candida vaginitis
Exclusion criteria:
Current using antifungal, antibiotic, immunosuppressive drugs or OCP
Unusual uterine bleeding
Recurrent Volvo vaginitis
Pregnancy
Breastfeeding
Using alcohol
Age
From 18 years old to 44 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind
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
2019-06-19, 1398/03/29
Ethics committee reference number
IR.UMSHA.REC.1398.347
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
Assessing the vaginal lesions
Timepoint
Before the intervention and one week after the intervention
Method of measurement
By physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group Compound vaginal cream (honey, olive oil and propolis) 60 g every night using intravaginal applicator for 7 days
Category
Treatment - Drugs
2
Description
Control group: Clotrimazole vaginal cream 1% 5 g every night using intravaginal applicator for 7 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers in Hamadan City
Full name of responsible person
Arezoo Shayan
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Arezoo.shayan2012@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
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
Arezoo Shayan
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Arezoo.shayan2012@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Seyedeh Zahra Masoumi
Position
Reproductive Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahramid2001@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