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IRCT20190123042475N2 IRCT 2019-07-26 Bojnourd University of Medical Sciences Effect of a poly herbal mouthwash in prevention of mucositis Efficacy of a poly herbal mouthwash in prevention of head and neck radiotherapy-induced-oral mucositis: A double-blind randomized placebo-controlled trial 2019-04-21 anticipated 75 Complete https://irct.ir/trial/38144 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: This will be done for the first time in Iran, Randomization description: The eligible people will be assigned in to one of the following research groups, using the standard random numbers table. At first, some part of a printed paper filled with six-digit random numbers will be selected randomly. if the selected number ends in one of the following numbers of 1, 2 or 3, this code will be assigned to intervention group 1 (Herbal mouthwash); if it ends in 4, 5 or 6, it will be assigned to intervention 2 group (Chlorhexidine mouthwash); and if the mentioned number ends in 7, 8 or 9, it will be assigned to placebo group. The number zero will not be considered here. For appropriated blinding, the selection of random allocation codes and corresponding mouthwash allocations is done by a researcher from the research team who is not directly involved in the treatment team, Blinding description: This study was a prospective, double-blinded, randomized controlled clinical trial And will be performed on 75 patients who will be randomly assigned to three 25-patient groups of controls or intervention. After completing the preparation of the products, the principal investigator puts mouthwashes in the same 120-cc glasses for one week use of the patients and identifies them with a six-digit number. Patients, treatment team and investigator of clinical responses will not be aware of the types of interventions. At the end of the study, the principal investigator will decode the numbers of consumed mouthwashes and assign each to the appropriate group correctly. 3 oral mucositis. Intervention 1: Intervention group 1: poly herbal mouthwash containing Aloe vera gel 3%, Chamomile extract 1%, honey 1.5%, oil mint 1%, will be formulated in pharmacy faculty of Mashhad. All prepared mouthwash will be poured into the 120 cc glasses for one week consumption of the patient. The patients will rinse the mouthwash 3 times a day, 5 cc each time for 6 weeks. Intervention 2: Intervention group 2: chlorhexidine mouthwash with Vi-one brand (Rozhin Company) will be prepared from pharmacy. The mouthwash will be poured into the 120 cc glasses for one week consumption of the patient. The patients will rinse the mouthwash 3 times a day, 5 cc each time for 6 weeks. Intervention 3: Control group: Placebo mouthwash containing water, citric acid 0.3% and vitamin C 1%, will be formulated in pharmacy faculty of Mashhad. All prepared mouthwash will be poured into the 120 cc glasses for one week consumption of the patient. The patients will rinse the mouthwash 3 times a day, 5 cc each time for 6 weeks. 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 No more information
public Marzieh Sahebnasagh
Faculty of Dentistry, Shahriar Blvd, next to Imam Ali Hospital, Bojnurd, Iran
Bojnurd Iran (Islamic Republic of) 9418654514 +98 58 3272 8568 Marzieh.saheb@gmail.com Bojnourd University of Medical Sciences scientific Marzieh Sahebnasagh
Faculty of Dentistry, Shahriar Blvd, next to Imam Ali Hospital, Bojnurd, Iran
Bojnurd Iran (Islamic Republic of) 9418654514 +98 58 3272 8568 Marzieh.saheb@gmail.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) All patients over the age of 18 undergoing radiotherapy 18 years no limit Both co-existing systemic diseases K12.3 Oral mucositis (ulcerative) Prevention Prevention Prevention Intervention group 1: poly herbal mouthwash containing Aloe vera gel 3%, Chamomile extract 1%, honey 1.5%, oil mint 1%, will be formulated in pharmacy faculty of Mashhad. All prepared mouthwash will be poured into the 120 cc glasses for one week consumption of the patient. The patients will rinse the mouthwash 3 times a day, 5 cc each time for 6 weeks. Intervention group 2: chlorhexidine mouthwash with Vi-one brand (Rozhin Company) will be prepared from pharmacy. The mouthwash will be poured into the 120 cc glasses for one week consumption of the patient. The patients will rinse the mouthwash 3 times a day, 5 cc each time for 6 weeks. Control group: Placebo mouthwash containing water, citric acid 0.3% and vitamin C 1%, will be formulated in pharmacy faculty of Mashhad. All prepared mouthwash will be poured into the 120 cc glasses for one week consumption of the patient. The patients will rinse the mouthwash 3 times a day, 5 cc each time for 6 weeks. Clinical manifestations of mucositis. Timepoint: In the beginning of the study (before the onset of intervention), 1,2,3,4,5,6,7,8 weeks after commencing oral intake of poly herbal mouthwash. Method of measurement: Clinical Examination. Severity of mucositis based on the WHO benchmark. Timepoint: In the beginning of the study (before the onset of intervention), 1,2,3,4,5,6,7,8 weeks after commencing oral intake of poly herbal mouthwash. Method of measurement: World Health Organization classification system. Bojnourd University of Medical Sciences Approved 2019-03-16 Ethics Committee of North Khorasan University of Medical Sciences Ethics Committee, Deputy of Research, Shahriar Blvd, next to Imam Ali Hospital, Bojnurd, Iran Bojnurd North Khorasan Iran (Islamic Republic of)