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IRCT20230314057713N1 IRCT 2023-04-07 Babol University of Medical Sciences The effect of cassia fistula product The comparison of effect of the topical product of Cassia fistula on diaper rash of infants in comparison with hydrocortisone: a double-blind clinical trial 2023-04-03 anticipated 138 Complete https://irct.ir/trial/69153 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using the method of random permutation blocks. The size of the blocks is 4 and the ratio of drug to control (hydrocortisone ointment) in each group is equal (1:1). In each block, random permutations of 4 combinations of Flos and hydrocortisone formulations are considered, Blinding description: Cassia fistula product ointment and hydrocortisone will be packed and coded in a single form with the same consistency and color and smell (with the addition of color and essential oil) with the same label by a pharmaceutical specialist in the medicinal plant laboratory of the Iranian Medicine School of Babol. The only person who knows the nature of the drugs is the pharmacist who manufactures the drug. Random codes are written on the boxes containing the drug (floss/hydrocortisone product) and after assigning the drug to the patients, the relevant code is recorded on the patient's file. to be The opening of the codes will be done after the end of the study. 3 Inflammation of the diaper area. Intervention 1: Intervention group: The evaluation of people entering the study is done by a doctor specializing in children and infants, and in case of clinical suspicion that there is a severe disease and severe bacterial and fungal infections that have led to local inflammation (severe type or a score higher than 3 ) is removed from the study and is subjected to standard treatment. Every person who meets the criteria for entering the study is evaluated by an Iranian medical expert using the Ddsis tool (diaper dermatitis severity index score) in the first and subsequent visits and with this tool The score of the patient is determined. According to the summary of studies, the average recovery period is 7 days. The patients were followed up every day according to the assistant's phone call with the mother and based on the changes with the initial examination, and according to the in-person examination by the assistant on the first, fourth and seventh days, the changes in the score index were measured at the beginning and then at the end of the treatment, and statistically, between Two groups are compared. The duration of treatment is also evaluated. Intervention 2: Control group: The evaluation of people entering the study is done by a doctor specializing in children and infants, and in case of clinical suspicion that there is a severe disease and severe bacterial and fungal infections that have led to local inflammation (severe type or a score higher than 3 ) is removed from the study and is subjected to standard treatment. Every person who meets the criteria for entering the study is evaluated by an Iranian medical expert using the Ddsis tool (diaper dermatitis severity index score) in the first and subsequent visits and with this tool The score of the patient is determined. According to the summary of studies, the average recovery period is 7 days. The patients were followed up every day according to the assistant's phone call with the mother and based on the changes with the initial examination, and according to the in-person examination by the assistant on the first, fourth and seventh days, the changes in the score index were measured at the beginning and then at the end of the treatment, and statistically, between Two groups are compared. The duration of treatment is also 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 further information
public Dr. Ali Muzaffarpour
Babol University of Medical Sciences, University Square, Ganj Afrooz St
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3219 9592 Seyyedali1357@gmail.com Babol University of Medical Sciences scientific Dr. Ali Muzaffarpour
Babol University of Medical Sciences, University Square, Ganj Afrooz Street
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3219 9592 Seyyedali1357@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Infants under two years old age Inflammation of diaper area 1 day 2 years Both Atopic dermatitis and other skin dermatitis Other diaper rash treatment from 2 weeks ago Sever type or inflammation with above score 3 Drug sensivity Diarrhea Oral antibiotic consumption Treatment - Drugs Treatment - Drugs Intervention group: The evaluation of people entering the study is done by a doctor specializing in children and infants, and in case of clinical suspicion that there is a severe disease and severe bacterial and fungal infections that have led to local inflammation (severe type or a score higher than 3 ) is removed from the study and is subjected to standard treatment. Every person who meets the criteria for entering the study is evaluated by an Iranian medical expert using the Ddsis tool (diaper dermatitis severity index score) in the first and subsequent visits and with this tool The score of the patient is determined. According to the summary of studies, the average recovery period is 7 days. The patients were followed up every day according to the assistant's phone call with the mother and based on the changes with the initial examination, and according to the in-person examination by the assistant on the first, fourth and seventh days, the changes in the score index were measured at the beginning and then at the end of the treatment, and statistically, between Two groups are compared. The duration of treatment is also evaluated Control group: The evaluation of people entering the study is done by a doctor specializing in children and infants, and in case of clinical suspicion that there is a severe disease and severe bacterial and fungal infections that have led to local inflammation (severe type or a score higher than 3 ) is removed from the study and is subjected to standard treatment. Every person who meets the criteria for entering the study is evaluated by an Iranian medical expert using the Ddsis tool (diaper dermatitis severity index score) in the first and subsequent visits and with this tool The score of the patient is determined. According to the summary of studies, the average recovery period is 7 days. The patients were followed up every day according to the assistant's phone call with the mother and based on the changes with the initial examination, and according to the in-person examination by the assistant on the first, fourth and seventh days, the changes in the score index were measured at the beginning and then at the end of the treatment, and statistically, between Two groups are compared. The duration of treatment is also evaluated Duration of treatment. Timepoint: each day. Method of measurement: Counting days. Intensity of redness. Timepoint: Counting days. Method of measurement: diaper dermatitis severity index score. The extent of redness. Timepoint: Counting days. Method of measurement: Percentage of diaper area. Babol University of Medical Sciences Approved 2023-03-12 Ethics Committee of Babol University of Medical Sciences Keshavarz Street, University Square, Babol University of Medical Sciences Babol Mazandaran Iran (Islamic Republic of)