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IRCT20140818018842N52 IRCT 2026-06-29 Tehran University of Medical Sciences Assessment of the efficacy and safety of combined mouthwash containing cyclosporine, dexamethasone, and nystatin in treating chronic mucosal graft-versus-host disease in patients undergoing hematopoietic stem cell transplantation: a clinical trial Assessment of the efficacy and safety of combined mouthwash containing cyclosporine, dexamethasone, and nystatin in treating chronic mucosal graft-versus-host disease in patients undergoing hematopoietic stem cell transplantation: a clinical trial 2026-06-26 anticipated 20 Complete https://irct.ir/trial/76309 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 3 Chronic mucosal graft-versus-host disease (GVHD). Intervention group: The mouthwash will be administered topically, twice daily, 10 cc each time, for a duration of 1 to 5 minutes.. 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 here is no further information
public مریم برخوردار
Shariati Hospital, Kaargar shomali Ave.
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8800 4140 mbarkhordar@sina.tums.ac.ir Tehran University of Medical Sciences scientific مریم یرخوردار
Shariati Hospital, Kaargar shomali Ave.
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8800 4140 mbarkhordar@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Over 18 years old It has been over 100 days since the hematopoietic stem cell transplantation Chronic graft-versus-host disease (GVHD) evidence Clinical diagnosis of symptomatic erosive chronic graft-versus-host-disease (cGvHD) based on the treating physician,s assessment Informed consent of the patient for participation in the study 18 years no limit Both History of allergy to any of the excipients in the formulation including cyclosporine, dexamethasone and nystatin Simultaneous administration of systemic tacrolimus The presence of acute bacterial, viral or fungal oral infection Pregnancy or breastfeeding The occurrence of acute adverse effects leading to discontinuation of calcineurin inhibitors Non compliance with follow-up stages Patient,s non-adherence to proper medication usage or maintenance History of receiving topical oral corticosteroids within the past 12 weeks Simultaneous receipt of phototherapy D89.811 Chronic graft-versus-host disease Treatment - Drugs Intervention group: The mouthwash will be administered topically, twice daily, 10 cc each time, for a duration of 1 to 5 minutes. The severity of oral symptoms, including pain, burning, and dryness (based on VAS), and the severity of oral involvement due to cGVHD (based on the NIH oral score). Timepoint: 6 weeks. Method of measurement: Clinical evaluation- ٰVAS - NIH Oral score. Tehran University of Medical Sciences Approved 2024-10-30 Research Ethics Committee of the Pharmaceutical Sciences Research Center, Tehran University of Medic Pour Sina St, District 6, Tehran, Tehran Province Tehran Tehran Iran (Islamic Republic of)