average candida culture in the first group, consists of 45 patients treated with royal jelly before and after treatment will compared to the second group, consists of 45 patients treated with clotrimazole.
Design
This study is an open labels clinical trial that on 90 patients. Patients shall be included in the study randomly in two groups of 45 patients receiving royal jelly and 45 people in the control group receiving clotrimazole vaginal cream in equal numbers. The patients in the group receiving the royal jelly supplement receive royal jelly at a dose of 1000 mg daily for 10 days after the approval of the positive test of vaginal culture. In the control group, patients receive clotrimazole. Blood samples shall be taken in all of patients in order to measure the indicators related to the study and to evaluate the response to the treatment in a routine manner
Settings and conduct
The trial will be conducted in all hospitals related to Iran University of medicine
Participants/Inclusion and exclusion criteria
Inclusion criteria: married women with age between 18 and 50 with regular cycle.
Exclusion criteria: pregnancy and breastfeeding, infection disases, immune compromise patients, organ transplant, cancer, liver and kidney diseases, resistant to treatment fungal and bacterial infections.
Intervention groups
two groups of 45 patients receiving royal jelly and 45 people in the control group receiving clotrimazole vaginal cream
Main outcome variables
It will be shown if there exists a significant difference between average candida culture in two group of patients treated with royal jelly or clitromazole?
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220210053988N1
Registration date:2023-01-17, 1401/10/27
Registration timing:retrospective
Last update:2023-01-17, 1401/10/27
Update count:0
Registration date
2023-01-17, 1401/10/27
Registrant information
Name
Maryam Ramazanichaleshtori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 0602
Email address
dr.m.ramazani.m@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
2021-03-21, 1400/01/01
Actual recruitment end date
2022-03-21, 1401/01/01
Trial completion date
2022-03-21, 1401/01/01
Scientific title
The evaluation of the antifungal effect of Royal jelly on vaginal candidiasis; clinical randomized trial
Public title
The antifungal effect of Royal jelly on vaginal candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women
Age between 18-50
vaginal infection sign and symptoms
Exclusion criteria:
Pregnancy and breastfeeding
immune compromise patients
organ transplantation
cancer
renal and liver disease
resistant treatment bacterial and fungal infections
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
More than 1 sample in each individual
Number of samples in each individual:
2
average of candidias culture before and after treatment
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done with random allocation rule. We take 90 peaces of similar papers, on 45 cases wrote clotrimazole and on 45 cases wrote Royal Jelly. Mix them and put them in a bag and chose without constrained each time one case and order a list with output. Based on this list we know what kind of drug achieves the next patient.
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
IR.IUMS.FMD.REC.1399.865
Street address
Iran University of medical scienses
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-03-07, 1399/12/17
Ethics committee reference number
IR.IUMS.FMD.REC.1399.865
Health conditions studied
1
Description of health condition studied
vaginal candidiasis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
the average candida culture
Timepoint
From patients with vaginal signs we make the first culture test and set to lab. After the approval of the positive test of vaginal culture, the patients in the group receiving the royal jelly supplement, receive royal jelly at a dose of 1000 mg daily for 10 days. The second group that receive clotrimazole ( control group), patients receive clotrimazole for ten nights, each night one applicator. Then we make the second culture test for both groups. We compare the results for two groups.
Method of measurement
cultivation environment for candidia, spaculum, swap
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group consists of 45 patients which take royal jelly 1000 mg per day for ten days. The royal jelly used in this study with name Tang Forte is produced under licence of Health aid company of England by Omid Parsa company (OPD Pharma) of Iran. In this group we make vaginal smear culture one time before treatment and one time after treatment.
Category
Treatment - Drugs
2
Description
Control group: This group consists of 45 patients which take clotrimazol in normal dose(one applicator each day) for ten days. In this group we make vaginal smear culture one time before treatment and one time after treatment too.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasoole Akram Hospital
Full name of responsible person
Lida Sojoody
Street address
Niayesh Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
Rasoolhospital@iums.ac.ir
Web page address
https://hrmc.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hossein Keivani
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1000
Email
info@iums.ac.ir
Web page address
https://en.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Maryam Ramazanichaleshtori
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kooye Asatid-A19-Isfahan University Of Technology
City
Isfehan
Province
Isfehan
Postal code
8415683111
Phone
+98 31 3391 3183
Email
dr.m.ramazani.m@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Ramazanichslrshtori
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kooye Asatid- A19-Isfahan University Of Technology
City
Isfahan
Province
Isfehan
Postal code
8415683111
Phone
+98 31 3391 3183
Email
m.dr.ramazani.m@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Ramazanichaleshtori
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kooye Asatid-A19-Isfahan University Of Technology
City
Isfahan
Province
Isfehan
Postal code
8415683111
Phone
+98 31 3391 3183
Email
dr.m.ramazani.m@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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Questionnaire are available
When the data will become available and for how long
April 2023
To whom data/document is available
specialist and researchers of gynecology
Under which criteria data/document could be used
using for treatment or more investigations
From where data/document is obtainable
by email
What processes are involved for a request to access data/document