Evaluation of the clinical effectiveness of fluconazole lozenges in the treatment of oral candidiasis
Design
In this study, the phase 3 clinical trial is conducted on 50 patients, the patients are randomly divided into two groups of fluconazole and control (25 people in each group). The placement of patients in these two groups is simple and based on the RAND function of Excel software. This study is double-blind, and the doctor and the patient do not know which group they are in
Settings and conduct
A double-blind randomized controlled clinical trial related to oral candidiasis in patients admitted to Shahid Sadoughi Hospital in Yazd is conducted on 50 patients in two control and intervention groups. The physician and the statistical analyst do not know the type of intervention of the studied groups
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 70 years
Women are not pregnant or lactating
No history of fluconazole allergiy
Exclusion criteria:
occurrence of allergic reaction to fluconazole
exacerbation of the disease
Intervention groups
In the current study, patients will be divided into two groups: the group receiving fluconazole lozenges, the group receiving standard treatment.
Main outcome variables
Cotton feeling in the mouth, loss of taste, total area of oral candidiasis lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191106045356N16
Registration date:2023-01-25, 1401/11/05
Registration timing:registered_while_recruiting
Last update:2023-01-25, 1401/11/05
Update count:0
Registration date
2023-01-25, 1401/11/05
Registrant information
Name
Mohsen Zabihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3865
Email address
mzabihi100@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-06, 1401/09/15
Expected recruitment end date
2023-03-11, 1401/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of fluconazole lozenge on oral candidiasis in immunocompromised patients: an experimental study and a randomized clinical trial
Public title
The effect of fluconazole lozenge on oral candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient is undergoing cancer chemotherapy in Yazd hospitals.
The woman should not be pregnant or lactating.
Willingness to participate in the study and complete the informed consent form
Age 18 to 70 years
Exclusion criteria:
The occurrence of an allergic reaction to fluconazole
Aggravation of the disease and the need for drug intervention to control the disease
Non-cooperation in the use of medication
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who meet the inclusion criteria receive one of the drugs labeled A or B by a simple randomization method based on the random number function (RAND), of Excel software.
Intervention with each of these drugs four times a day and
It is done for 7 days. On the 1st, 3rd, 7th, and 14th days from the beginning of the intervention, cotton sensation in the mouth, loss of taste, and pain during eating and swallowing are checked.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Both placebo lozenges and placebo drops are prepared and placed next to lozenges containing fluconazole and nystatin drops in coded uniform containers. Patients of both study groups receive both lozenges and drops, one of which contains medicine and the other placebo. The prescribing phusician, the patient, and the data analyzer are not aware of their content.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Alem sq.
City
yazd
Province
Yazd
Postal code
8916978477
Approval date
2021-10-27, 1400/08/05
Ethics committee reference number
IR.SSU.MEDICINE.REC.1400.201
Health conditions studied
1
Description of health condition studied
Oral candidiasis
ICD-10 code
B37.0
ICD-10 code description
Candidal stomatitis
Primary outcomes
1
Description
Total area of oral candidiasis lesions
Timepoint
At the beginning of the treatment and after every 2 days until 10 days, the condition of oral candidiasis lesions is evaluated in terms of the total area of the lesions.
Method of measurement
Determining the total area of oral candidiasis lesions through Fiji software
Secondary outcomes
1
Description
Cotton feeling in the mouth
Timepoint
the beginning of the treatment and after every 2 days up to 10 days, the condition of oral candidiasis lesions is evaluated in terms of the feeling of cotton in the mouth (score 0 to 4).
Method of measurement
Scoring the feeling of cotton in the mouth using a questionnaire
2
Description
Decreased taste
Timepoint
At the beginning of treatment and after every 2 days until 10 days, the condition of oral candidiasis lesions is evaluated in terms of taste loss (score 0 to 4).
Method of measurement
Scoring of taste reduction using a questionnaire
Intervention groups
1
Description
Intervention group: Including 25 patients hospitalized in Yazd hospitals and undergoing cancer chemotherapy, who were diagnosed with oral candidiasis and met the inclusion criteria, and were randomly selected based on the RND function of Excel software. Patients in the fluconazole group use lozenges containing 20 mg of fluconazole orally 4 times a day on days 1 to 10. In this research, fluconazole lozenges are prepared using fluconazole powder purchased from Amin Pharmaceutical Company, which has a license from the Food and Drug Organization of Iran. At the beginning of the treatment and after every 2 days until 10 days, the condition of oral candidiasis lesions in terms of the total area of the lesions (score 0 to 4), intervention of cotton sensation in the mouth (score 0 to 4), loss of taste, (score 0 to 4) and the number of lesions are evaluated.
Category
Treatment - Drugs
2
Description
Control group: Including 25 patients hospitalized in Yazd hospitals and undergoing cancer chemotherapy, who were diagnosed with oral candidiasis and met the inclusion criteria, and were randomly selected based on the RND function of Excel software. Nystatin group patients use 20 drops of nystatin orally 4 times a day on days 1 to 10. In this study, Nystatin drops are obtained from Emad Pharmaceutical Company, which has a license from the Food and Drug Organization of Iran. At the beginning of the treatment and after every 2 days until 10 days, the condition of oral candidiasis lesions in terms of the total area of the lesions (score 0 to 4), intervention of cotton sensation in the mouth (score 0 to 4), loss of taste, (score 0 to 4) and the number of lesions are evaluated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
hospitals
Full name of responsible person
Dr. Mohsen Zabihi
Street address
Alem sq.
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Masood Mirzaei
Street address
Bahonar sq.
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
yazd
Province
Yazd
Postal code
8916774520
Phone
+98 35 3820 3865
Email
mzabihi100@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
yazd
Province
Yazd
Postal code
8916774520
Phone
+98 35 3820 3865
Email
mzabihi100@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
yazd
Province
Yazd
Postal code
8916774520
Phone
+98 35 3820 3865
Email
mzabihi100@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