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IRCT20180516039682N3 IRCT 2020-12-30 Zanjan University of Medical Sciences Effect of Achillea wilhelmsii oral rinse on chemoradiotherapy induced oral mucositis in head and neck cancers Evaluating the effect of Achillea wilhelmsii oral rinse on chemoradiotherapy induced oral mucositis in head and neck cancer patients 2021-01-20 anticipated 36 Complete https://irct.ir/trial/51721 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization: A person other than the investigator will blindly and randomly select a number from the random number table for each patient (by moving in all four directions up, down, left and right). If the selected number is even, the patient will assign to the control group and if the selected number is odd, the patient will assign to the intervention group, Blinding description: In this study, Achillea wilhelmsii mouthwash and normal saline mouthwash (placebo) will be available to patients in bottles of the same shape, size and dark color. Participants , outcome assessor and data analyzer will be blinded to the type of mouthwash and the patient's group. In this study, the pharmacist, as the person responsible for preparing mouthwash, will not be blinded to the study groups. 3 Oral mucositis (Stomatitis). Intervention 1: Intervention group: From the first day of cancer treatment, the intervention group will use Achillea wilhelmsii mouthwash. Achillea wilhelmsii mouthwash will be prepared in the pharmacognosy laboratory of the Faculty of Pharmacy of Zanjan University of Medical Sciences. Patients should hold 15 ml of the prescribed mouthwash in their mouth for 3 minutes 4 times a day (after each meal and before bed) and then expel it. Patients will undergo oral examination on days 0, 7, 14, 21, and 28 to evaluate the severity of the mucositis (according to World Health Organization scale). Immediately after occurrence of grade 1 mucositis, in addition to using Achillea wilhelmsii mouthwash, patients will use Magic mouthwash, which is a common treatment for oral mucositis due to cancer treatment. Intervention 2: Control group: From the first day of cancer treatment, the control group will use placebo mouthwash. Normal saline solution produced by Shahid Ghazi Pharmaceutical Company of Tabriz will be used as a placebo. Patients should hold 15 ml of the prescribed mouthwash in their mouth for 3 minutes 4 times a day (after each meal and before bed) and then expel it. Patients will undergo oral examination on days 0, 7, 14, 21, and 28 to evaluate the severity of the mucositis (according to World Health Organization scale). Immediately after occurrence of grade 1 mucositis, in addition to using placebo mouthwash, patients will use Magic mouthwash, which is a common treatment for oral mucositis due to cancer treatment. 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 There is no further information.
public Dr. Raheleh Akhavan Rasoolzadeh
Faculty of dentistry, Zanjan university of medical sciences, 13th Ave., Mahdavi Blvd., Shahrak Karmandan
Zanjan Iran (Islamic Republic of) 4515613191 +98 24 3314 8101 R.rasoolzadeh@zums.ac.ir Zanjan University of Medical Sciences scientific Dr. Raheleh Akhavan Rasoolzadeh
Faculty of dentistry, Zanjan university of medical sciences, 13th Ave., Mahdavi Blvd., Shahrak Karmandan
Zanjan Iran (Islamic Republic of) 4515613191 +98 24 3314 8101 R.rasoolzadeh@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Patients with full consciousness Patients older than 18 years and younger than 60 years Patients with head and neck malignancies Patients undergoing chemotherapy and radiotherapy 18 years 60 years Both Patients with oral mucositis Patients with any systemic diseases other than head and neck malignancies Patients with a history of allergy to Achillea wilhelmsii and medicinal plants Patients with a history of chemotherapy or radiotherapy Patients with xerostomia Use of drugs that reduce salivation Use of antibiotics, antifungals and systemic anti-inflammatory drugs Patients with malnutrition Smoking and alcohol consumption Use of dentures K12 Stomatitis and related lesions Treatment - Drugs Placebo Intervention group: From the first day of cancer treatment, the intervention group will use Achillea wilhelmsii mouthwash. Achillea wilhelmsii mouthwash will be prepared in the pharmacognosy laboratory of the Faculty of Pharmacy of Zanjan University of Medical Sciences. Patients should hold 15 ml of the prescribed mouthwash in their mouth for 3 minutes 4 times a day (after each meal and before bed) and then expel it. Patients will undergo oral examination on days 0, 7, 14, 21, and 28 to evaluate the severity of the mucositis (according to World Health Organization scale). Immediately after occurrence of grade 1 mucositis, in addition to using Achillea wilhelmsii mouthwash, patients will use Magic mouthwash, which is a common treatment for oral mucositis due to cancer treatment. Control group: From the first day of cancer treatment, the control group will use placebo mouthwash. Normal saline solution produced by Shahid Ghazi Pharmaceutical Company of Tabriz will be used as a placebo. Patients should hold 15 ml of the prescribed mouthwash in their mouth for 3 minutes 4 times a day (after each meal and before bed) and then expel it. Patients will undergo oral examination on days 0, 7, 14, 21, and 28 to evaluate the severity of the mucositis (according to World Health Organization scale). Immediately after occurrence of grade 1 mucositis, in addition to using placebo mouthwash, patients will use Magic mouthwash, which is a common treatment for oral mucositis due to cancer treatment. Onset time of oral mucositis. Timepoint: Days 0, 7, 14, 21 and 28 after starting cancer treatment. Method of measurement: Clinical examination by a dentist based on World Health Organization oral mucositis grading scale. Severity of oral mucositis. Timepoint: Days 0, 7, 14, 21 and 28 after starting cancer treatment. Method of measurement: Clinical examination by a dentist based on World Health Organization oral mucositis grading scale. Patient's weight. Timepoint: Days 0, 7, 14, 21 and 28 after starting cancer treatment. Method of measurement: Using a digital scale. Severity of oral pain. Timepoint: Days 0, 7, 14, 21 and 28 after starting cancer treatment. Method of measurement: Questionnaire. Satisfaction with mouthwash. Timepoint: Days 0, 7, 14, 21 and 28 after starting cancer treatment. Method of measurement: Questionnaire. Zanjan University of Medical Sciences Approved 2020-09-01 Ethics committee of Zanjan University of Medical Sciences Central Station of Zanjan University of Medical Sciences, The Beginning of the Islamic Republic Boulevard, Azadi Square, Zanjan Zanjan Zanjan Iran (Islamic Republic of)