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IRCT20191106045356N8 IRCT 2021-08-06 Yazd University of Medical Sciences Preparation and clinical evaluation of a novel colchicine mucoadhesive gel for the treatment of aphthous stomatitis Preparation and clinical evaluation of a novel colchicine mucoadhesive gel for the treatment of aphthous stomatitis: An experimental study and a double blinded randomized clinical trial 2021-08-21 anticipated 50 Complete https://irct.ir/trial/57635 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is performed based on the RND function of Excel software and patients are divided into two groups A and B. The drug and placebo are uniform and coded in terms of the shape of the drug and the drug container, and the patient and the physician prescribing the drug and the evaluator do not know the composition and content of each drug container, Blinding description: Different groups of drugs are placed in uniform and coded containers, and the prescribing physician and the evaluator do not know the composition and content of each drug container. 3 Aphthous stomatitis. Intervention 1: Intervention group: Includes 25 patients selected from the city's pharmacies and randomly selected based on the RND function of Excel software. Patients will use the prepared drug twice a day (0.05% colchicine adhesive mucus gel) at the rate of one drop for each aphthous. At the beginning of treatment and after every 2 to 10 days, the condition of the aphthous lesions is evaluated in terms of pain intensity (score 0 to 4), total lesion area and intensity of redness and inflammation (score 0 to 4) and number of lesions. Intervention 2: Control group: Includes 25 patients selected from the city's pharmacies and randomly selected based on the RND function of Excel software. Patients will use one placebo twice a day (base glue-free mucosal gel without colchicine) at the rate of one drop per aphthous. At the beginning of treatment and after every 2 to 10 days, the condition of the aphthous lesions is evaluated in terms of pain intensity (score 0 to 4), total lesion area and intensity of redness and inflammation (score 0 to 4) and number of lesions. 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 further 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) Patients with aphthous stomatitis starting up to two days Patient between 18-65 years old No pregnancy and lactation No history of allergies to colchicine 18 years 65 years Both Patients with skin diseases Sensitivity to colchicine or any of the components of the product Do not use the drug for two consecutive days Exacerbation of the aphthous stomatitis Treatment - Drugs Placebo Intervention group: Includes 25 patients selected from the city's pharmacies and randomly selected based on the RND function of Excel software. Patients will use the prepared drug twice a day (0.05% colchicine adhesive mucus gel) at the rate of one drop for each aphthous. At the beginning of treatment and after every 2 to 10 days, the condition of the aphthous lesions is evaluated in terms of pain intensity (score 0 to 4), total lesion area and intensity of redness and inflammation (score 0 to 4) and number of lesions. Control group: Includes 25 patients selected from the city's pharmacies and randomly selected based on the RND function of Excel software. Patients will use one placebo twice a day (base glue-free mucosal gel without colchicine) at the rate of one drop per aphthous. At the beginning of treatment and after every 2 to 10 days, the condition of the aphthous lesions is evaluated in terms of pain intensity (score 0 to 4), total lesion area and intensity of redness and inflammation (score 0 to 4) and number of lesions. Severity of pain. Timepoint: At the beginning of treatment and after every 2 to 10 days, the condition of aphthous lesions is evaluated for pain intensity (score 0 to 4). Method of measurement: Scoring pain using a questionnaire. Redness and inflammation. Timepoint: At the beginning of treatment and after every 2 to 10 days, the condition of aphthous lesions is evaluated for the severity of redness and inflammation (score 0 to 4). Method of measurement: Scoring severe redness and inflammation using a questionnaire. Total area of ​​aphthous lesions. Timepoint: At the beginning of treatment and after every 2 to 10 days, the condition of the aphthous lesions is evaluated in terms of the total area of ​​the aphthous lesions. Method of measurement: Determining the total area of ​​aphthous lesions through Fiji software. Yazd University of Medical Sciences Approved 2021-08-21 Ethics committee of Shahid Sadoughi University of Medical Sciences Alem sq. Yazd Yazd Iran (Islamic Republic of)