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IRCT20190917044805N1 IRCT 2019-12-05 Tehran University of Medical Sciences Evaluating effects of Sodium Hyaluronate and four amino acids in oral mucositis prevention Evaluating the effects of a combined product of Sodium Hyaluronate, Glycine, L-Proline, L-Leucine, L-Lysine in preventing the occurrence of Oral Mucositis in pediatric Hematopoietic Stem Cell Transplant patients 2019-12-21 anticipated 60 Complete https://irct.ir/trial/42216 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Blocked randomization method will be used to randomize patients to blocks of four, using an random number table which was built by a computer software by the statistic's expert will be utilized to randomly assign the patients to placebo or medication groups, Blinding description: The blinding procedure is carried out using a random number table, which is going to be provided by statistics expert, each number of the table is going to be assigned to a specific patient and the researcher, nurses and patients are not going to be aware of the product ingredients. Only product provider and safety board of the study would know which product contains drug or placebo.The researcher will receive the products in sealed and labeled containers and randomly deliver them to patients. 3 oral mucositis. Intervention 1: Intervention group: patients in this group will receive topical mucosamine spray manufactured by Professional Dietetics Italy, four times daily 7 days before receipt of hematopeitic stem cells till 7 days after transfusion of hematopeitic stem cells. the topical spray contains Sodium Hyaluronate, Glycine, L-Proline, L-Leucine and L-Lysine. Intervention 2: Control group: the patients in control group will receive the placebo product containing all the ingredients of medication product but with out Sodium Hyaluronate, Glycine, L-Proline, L-Leucine and L-Lysine, four times daily 7 days before receipt of hematopeitic stem cells till 7 days after transfusion of hematopeitic stem cells. No - There is not a plan to make this available Justification or reason for not sharing IPD is it is the study policy to keep patient information secret as agreed in informed consent note
public kurosh sadeghi
16th Azar street
Tehran Iran (Islamic Republic of) 14176114411 +98 21 8490 1000 sadeghi_k@tums.ac.ir Tehran University of Medical Sciences scientific kurosh sadeghi
16th Azar street
Tehran Iran (Islamic Republic of) 1417614411 +98 21 8490 1000 sadeghi_k@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age below 18 years old Undergoing allogenic hematopeitic stem cell transplantation 4 years 18 years Both Patients with active oral mucositis at the time of admission History of hypersensitivity reactions to mucosamine spray or any of its ingreedients Patients with the diagnosis of fanconie's anemia K12.30 Oral mucositis (ulcerative), unspecified Prevention Placebo Intervention group: patients in this group will receive topical mucosamine spray manufactured by Professional Dietetics Italy, four times daily 7 days before receipt of hematopeitic stem cells till 7 days after transfusion of hematopeitic stem cells. the topical spray contains Sodium Hyaluronate, Glycine, L-Proline, L-Leucine and L-Lysine. Control group: the patients in control group will receive the placebo product containing all the ingredients of medication product but with out Sodium Hyaluronate, Glycine, L-Proline, L-Leucine and L-Lysine, four times daily 7 days before receipt of hematopeitic stem cells till 7 days after transfusion of hematopeitic stem cells. Oral mucositis severity. Timepoint: every other day, since the day of admission till the day of discharge. Method of measurement: National Cancer Institute Common Terminology of Adverse Events criteria version 5. Mucositis incidence. Timepoint: Every other day. Method of measurement: Observation. Tehran University of Medical Sciences Approved 2019-09-03 Ethic's committee of tehran university of medical sciences 16th azar street Tehran Tehran Iran (Islamic Republic of)