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IRCT20130812014333N197 IRCT 2023-02-24 Kermanshah University of Medical Sciences Efficacy of 10% honey and 5% frankincense gel in the treatment of mucositis caused by radiotherapy in cancer patients Investigating the effect of 10% honey and 5% frankincense gel in the treatment of mucositis caused by radiotherapy in cancer patients: a parallel, randomized clinical trial 2022-12-31 anticipated 60 Complete https://irct.ir/trial/67111 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization method. Numbers 1-60 on the registration card, all codes are recorded on Card and stored in specific envelopes. Each of the generated codes is kept separately inside the envelope and the secretary gives one of these envelopes to the patient before the patient enters the doctor's room. Accordingly, the next patient code is not predictable. The doctor determines which treatments to perform based on the patient's code (If the number on the right side of the selected code is even, it will be in the intervention group, and if it is odd, it will be in the control group). Only the physician performing the intervention will be aware of the code assigned to the patient. After evaluating the outcome, based on the patient's name, the collected information will be linked to the assigned code. 2-3 Cancer. Intervention 1: The intervention group will use topical gel containing frankincense (10 percent) and honey twice daily for a week to ten days (the gel will be manufactured by Ariogen Sina Daru pharmaceutical company). Intervention 2: The control group will use the placebo gel (Gel containing carbomer does not contain active ingredient) twice a day for a week to ten days. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Dr. Seyed Shahram Miraghaei
Medical Biology Research Center
Kermanshah Iran (Islamic Republic of) 6714415153 +98 83 3426 6780 shahram.miraghaee@yahoo.com Kermanshah University of Medical Sciences scientific Dr. Seyed Shahram Miraghaei
Medical Biology Research Center
Kermanshah Iran (Islamic Republic of) 6714415153 +98 83 3426 6780 shahram.miraghaee@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Informed consent Radiotherapy candidate patients in such a way that at least one third of the oral mucosa is included No history of head and neck radiotherapy no limit no limit Both A history of frankincense allergy receiving concurrent chemotherapy regimen (other than cisplatin or cetuximab) Patients with liver problems Diabetes and history of hypoglycemia Patients with recurrent infections The presence of similar wounds in the genital area Joint swelling and pain, eye problems such as pain, blurriness and redness Using other drugs to treat the pest C80.0 Disseminated malignant neoplasm, unspecified Treatment - Drugs Placebo The intervention group will use topical gel containing frankincense (10 percent) and honey twice daily for a week to ten days (the gel will be manufactured by Ariogen Sina Daru pharmaceutical company). The control group will use the placebo gel (Gel containing carbomer does not contain active ingredient) twice a day for a week to ten days. Pain intensity. Timepoint: Zero, first, sixth and tenth days. Method of measurement: Using a visual pain scale. Sense of taste. Timepoint: The zero and seventh days of study. Method of measurement: Using Patient Reported Outcome Measures (PROMS). Ability to swallow solid and liquid substances. Timepoint: The zero and seventh days of study. Method of measurement: Using Patient Reported Outcome Measures (PROMS). Speech disorder. Timepoint: The zero and seventh days of study. Method of measurement: Using Patient Reported Outcome Measures (PROMS). Kermanshah University of Medical Sciences Approved 2022-11-01 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)