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IRCT20160415027393N3 IRCT 2025-07-15 Tabriz University of Medical Sciences Study the effect of spray coldamaris in recovery of oral mucositis in stem cells transplantation patients Study the effect of spray coldamaris in recovery of oral mucositis in stem cells transplantation patients 2025-06-10 anticipated 50 Complete https://irct.ir/trial/84595 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: The allocation of samples will be random, and the samples will be divided into control and intervention groups. In each group, 25 patients will be randomly selected. Patients who develop mucositis will use a solution of carrageenan (which has FDA approval under Sec. 172.620, and is also approved by the Iranian Food and Drug Organization and the FDA) three times daily for one week. The outcomes will be compared with a group of patients who develop mucositis but do not use this medication. A comparison of the results between the control and intervention groups will be performed, Blinding description: In a single-blind study, the patient participates with full informed consent but does not know the specific name of the medication they are receiving among the possible treatment options. 3 Study the effect of spray coldamaris in recovery of oral mucositis in stem cellstransplantation patients. Intervention group: Patients with myeloma, lymphoma, leukemia. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because this study requires further extensive research.
public Babak nejati
Tabriz University of Medical Sciences, Faculty of Medicine
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3337 3207 nejatib@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Babak nejati
Tabriz University of Medical Sciences, Faculty of Medicine
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3337 3207 nejatib@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) This study is a clinical study on 50 patients suffering from acute myeloma, pneumonia, and leukemia, who were hospitalized in the educational treatment ward of Shahid Ghazi Tabatabaei Hospital in Tabriz over the course of one year. After bone marrow transplantation, the mucositis incidence and severity were evaluated and its correlation with clinical and paraclinical findings was examined. 18 years 65 years Both Treatment - Drugs Intervention group: Patients with myeloma, lymphoma, leukemia The primary outcome of the study is the improvement in the severity and extent of oral mucositis in patients undergoing stem cell transplantation, measured using a standard mucositis severity assessment scale (e.g., WHO Oral Mucositis Scale) on specific days after transplantation. Improvement includes the reduction of clinical symptoms of mucositis such as inflammation, pain, and oral ulcers. Timepoint: days 1 to 21 after transplantation. Method of measurement: WHO Oral Mucositis Scale. The relationship between the severity of mucositis and laboratory markers, including ESR, LDH, fibrinogen, albumin, ferritin, and neutrophil count before transplantation, will be examined. Timepoint: Evaluation with laboratory tests one to three days before transplantation. Method of measurement: Laboratory tests and Statistical methods. Tabriz University of Medical Sciences Approved 2025-06-08 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)