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IRCT20220115053724N1 IRCT 2022-09-23 Ahvaz University of Medical Sciences Evaluation of the clinical effect of Methylprednisolone lozenge in oral lichen planus Evaluation of the effect of Methylprednisolone lozenge to improve symptoms of patient with oral lichen planus: An experimental study and a double-blinded randomized clinical trial 2022-09-23 anticipated 40 Complete https://irct.ir/trial/65526 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For blindness, different groups of drugs are placed in uniform and coded containers labeled A or B. In such a way that the physician and the patient do not know the type of medicine in each medicine container. 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. Patients will take the drug twice times a day and at the beginning of treatment and after every 2 days for up to 10 days, the status of oral lichen planus lesions will be evaluated, 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. the drug and the placebo are completely similar in terms of shape, color, smell, and taste. 3 Oral lichen planus disease. Intervention 1: Intervention group: including 20 patients who are diagnosed with oral lichen planus patients is based on the examination of the patient by a dentist specializing in oral and dental diseases or a biopsy of the tissue of one or more ulcers in the mouth. Patients in the methylprednisolone group, on days 1 to 10, use a lozenge containing 2 mg of methylprednisolone orally twice a day. In this research, methylprednisolone lozenge is prepared using methylprednisolone powder purchased from Caspian Pharmaceutical Company, which has a license from the Food and Drug Organization of Iran, and its safety is checked using standard quantitative and qualitative methods and toxicology.At the beginning of treatment and after every 2 to 10 days, the status of oral lichen planus lesions in terms of pain intensity and irritation (score 0 to 4), and severity of redness and inflammation (score 0 to 4), and the number of lesions were assessed through a questionnaire. Placed. Intervention 2: Control group: includes 20 patients who are diagnosed with oral lichen planus based on the patient's examination by a dentist or oral biopsy of one or more wounds in the mouth. Patients in the control group use topical corticosteroids such as triamcinolone acetonide twice times a day for days 1 to 10, which is considered as the standard and accepted treatment for this disease according to reliable medical sources. At the beginning of treatment and after every 2 to 10 days, the status of oral lichen planus lesions in terms of pain intensity and irritation (score 0 to 4), and severity of redness and inflammation (score 0 to 4), and the number of lesions were assessed through a questionnaire. 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 Javad Kushki
Golestan St., Shahrivar St., between Bahman and Esfand, No. 147, Unit 5
Ahvaz Iran (Islamic Republic of) 6135953731 +98 21 6624 5047 javaddorton@yahoo.com Ahvaz University of Medical Sciences scientific Mohammadreza Rashidi Nooshabadi
Esfand, Golestan, west beach, faculty of pharmacy, Gundishapur medical cciences University,Ahvaz
Ahvaz Iran (Islamic Republic of) 6135953731 +98 61 3311 5135 abd.rashidi@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age 18 to 60 years Willingness to participate in the study and complete the ethical consent form Women should not be pregnant or lactating Not using allopurinol Not using viral vaccines during treatment Patients do not have a confirmed history of allergic reactions following the oral intake of methylprednisolone The patient does not have a low level of consciousness The patient should not be treated with warfarin The patient does not have an active viral disease 18 years 60 years Both Aggravation of oral lichen lesions Unwillingness to cooperate during treatment Not using medicine for two consecutive days Emergence of allergic reaction to methylprednisolone L43.8 Other lichen planus Treatment - Drugs Treatment - Drugs Intervention group: including 20 patients who are diagnosed with oral lichen planus patients is based on the examination of the patient by a dentist specializing in oral and dental diseases or a biopsy of the tissue of one or more ulcers in the mouth. Patients in the methylprednisolone group, on days 1 to 10, use a lozenge containing 2 mg of methylprednisolone orally twice a day. In this research, methylprednisolone lozenge is prepared using methylprednisolone powder purchased from Caspian Pharmaceutical Company, which has a license from the Food and Drug Organization of Iran, and its safety is checked using standard quantitative and qualitative methods and toxicology.At the beginning of treatment and after every 2 to 10 days, the status of oral lichen planus lesions in terms of pain intensity and irritation (score 0 to 4), and severity of redness and inflammation (score 0 to 4), and the number of lesions were assessed through a questionnaire. Placed. Control group: includes 20 patients who are diagnosed with oral lichen planus based on the patient's examination by a dentist or oral biopsy of one or more wounds in the mouth. Patients in the control group use topical corticosteroids such as triamcinolone acetonide twice times a day for days 1 to 10, which is considered as the standard and accepted treatment for this disease according to reliable medical sources. At the beginning of treatment and after every 2 to 10 days, the status of oral lichen planus lesions in terms of pain intensity and irritation (score 0 to 4), and severity of redness and inflammation (score 0 to 4), and the number of lesions were assessed through a questionnaire. Redness and inflammation. Timepoint: At the beginning of treatment and after every 2 to 10 days, the status of oral lichen planus lesions is evaluated for the severity of redness and inflammation (score 0 to 4). Method of measurement: Scoring severe redness and inflammation using a Reeda questionnaire. Severe pain and burning. Timepoint: At the beginning of treatment and after every 2 to 10 days, the condition of oral lichen planus lesions is evaluated for the severity of pain and burning (score 0 to 4). Method of measurement: Scoring Severe pain and burning using VAS questionnaire. Ahvaz University of Medical Sciences Approved 2022-08-20 Ethics Committee of JundiShapur Ahvaz University of Medical Sciences Ahvaz, Golestan Boulevard, Farvardin St., Shahrivar St., between Bahman and Esfand. No. 147, Unit 5 Ahvaz Khouzestan Iran (Islamic Republic of)