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IRCT20191106045356N16 IRCT 2023-01-25 Yazd University of Medical Sciences The effect of fluconazole lozenge on oral candidiasis The effect of fluconazole lozenge on oral candidiasis in immunocompromised patients: an experimental study and a randomized clinical trial 2022-12-06 anticipated 50 Complete https://irct.ir/trial/67122 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Oral candidiasis. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Dr. Mohsen Zabihi
Alem sq.
yazd Iran (Islamic Republic of) 8916774520 +98 35 3820 3865 mzabihi100@gmail.com Yazd University of Medical Sciences scientific Dr. Mohsen Zabihi
Alem sq.
yazd Iran (Islamic Republic of) 8916774520 +98 35 3820 3865 mzabihi100@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) 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 18 years 70 years Both 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 B37.0 Candidal stomatitis Treatment - Drugs Treatment - Drugs 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. 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. 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. 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. 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. Yazd University of Medical Sciences Approved 2021-10-27 Ethics committee of Shahid Sadoughi University of Medical Sciences Alem sq. yazd Yazd Iran (Islamic Republic of)