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IRCT20200303046685N1 IRCT 2020-06-29 Esfahan University of Medical Sciences Effectiveness of licorice and triamcinolone acetonide muco-adhesive films on mucositis Evaluation of the effectiveness of licorice mucoadhesive film and triamcinolone acetonide mucoadhesive film on symptoms of head and neck radiotherapy-induced mucositis in comparison with placebo 2019-12-11 anticipated 90 Complete https://irct.ir/trial/46440 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Among patients suffering from oral mucositis induced by head and neck radiotherapy who refereed to Seyed-olshohada hospital in Isfahan, 90 patients who have been examined by supervisor and have met the eligibility criteria, will enter the study and a number will be assigned to every patient. Then they will be divided into two intervention groups and one control group using block randomization (block size=30) through the random allocation service software. For allocation concealment, sealed coded boxes with randomized sequence with the same size and weight will be used, Blinding description: Both the participant and the investigator are not aware of the administered medication because of the similarity of the films In appearance, color and smell provided to the participants. 3 oral mucositis. Intervention 1: Intervention group 1: Licorice mucoadhesive film, with Aphthogel brand name, made by Dr Saniee Pharmaceutical Company, locally applied on upper lip mucosa, after each meal and once before sleep, for 15 to 20 minutes. Intervention 2: Intervention group 2: Triamcinilone acetonide mucoadhesive film, with 1mg active ingredient, made by Dr Saniee Pharmaceutical Company, locally applied on upper lip mucosa, after each meal and once before sleep, for 15 to 20 minutes. Intervention 3: Control group: placebo mucoadhesive film with the same formulation as other drugs used in the study but without licorice and triamcinolone, made by Dr Saniee Pharmaceutical Company, locally applied on upper lip mucosa, after each meal and once before sleep, for 15 to 20 minutes. Yes - There is a plan to make this available What will be shared: Only information such as main consequence or the like can be shared. When: Access to the results immediately after publication To whom: Open access Conditions: Access to data is possible only after formal permission from corresponding author Where to obtain: Corresponding author How to obtain: Formal letter or email Comments:
public Fahimeh pakravan
Department of oral medicine Faculty of Dentistry; Isfahan University of Medical Sciences; Hezarjarib street
Isfahan Iran (Islamic Republic of) 817473461 +98 31 3436 8793 pakravan@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Fahimeh Pakravan
Department of oral medicine Faculty of Dentistry; Isfahan University of Medical Sciences; Hezarjarib street
Isfahan Iran (Islamic Republic of) 817473461 +98 31 3792 5515 Pakravan@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with radiotherapy induced oral mucositis Age above 18 years Non-pregnant women Patient willingness to remain in the study 18 years no limit Both History of drug abuse that interferes with the treatment procedure in the researcher’s point of view simultaneous treatment with another drug allergy or intolerance to corticosteroids inability to provide informed consent high blood pressure active gastric ulcer liver disease, neural disease Endocrine disorders or other significant systemic diseases that make it difficult to implement the protocols or test the results K12.33 Oral mucositis (ulcerative) due to radiation Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Licorice mucoadhesive film, with Aphthogel brand name, made by Dr Saniee Pharmaceutical Company, locally applied on upper lip mucosa, after each meal and once before sleep, for 15 to 20 minutes. Intervention group 2: Triamcinilone acetonide mucoadhesive film, with 1mg active ingredient, made by Dr Saniee Pharmaceutical Company, locally applied on upper lip mucosa, after each meal and once before sleep, for 15 to 20 minutes. Control group: placebo mucoadhesive film with the same formulation as other drugs used in the study but without licorice and triamcinolone, made by Dr Saniee Pharmaceutical Company, locally applied on upper lip mucosa, after each meal and once before sleep, for 15 to 20 minutes. Mucositis Grade. Timepoint: At the beginning of the study and at days 7,14 and 21. Method of measurement: WHO mucositis assessment scale. Oral pain. Timepoint: At the beginning of the study and at days 7,14 and 21. Method of measurement: VAS ( visual analogue scale). Esfahan University of Medical Sciences Approved 2019-12-19 Ethics committee of Isfahan University of Medical Sciences Department of oral medicine Faculty of Dentistry; Isfahan University of Medical Sciences; Hezarjarib street Isfahan Isfehan Iran (Islamic Republic of)