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IRCT20190703044082N3 IRCT 2020-11-26 Hamedan University of Medical Sciences The effect of mouthwash on the treatment of oral mucositis Comparison of the effect of sodium bicarbonate and zinc chloride mouthwashes on treatment of oral mucositis in patients with cancer under chemotherapy in Hamadan Imam Khomeini clinic, 2019 2020-09-22 anticipated 144 Complete https://irct.ir/trial/52158 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomly assign the participants to the zinc chloride, sodium bicarbonate and control groups, write the names of the three groups on a piece of paper and remove them randomly and the order of sampling of the groups will be determined.For random allocation of samples in three groups, 20 blocks of 6 will be used as random block allocation. Thus, the letter A will be considered for the zinc chloride group, the letter B for the sodium bicarbonate group and the letter C for the control group.On pieces of paper, and we will come across randomly. Sampling will then begin according to the possible order, Blinding description: In which patients will be blind about their allocation in intervention groups. In addition, the person who will analyze the data will be blind about the allocation of people in the groups. 3 cancer. Intervention 1: Intervention group: Intervention group (A)Receives 10% zinc chloride solution 2 times every 8 hours and 10 cc each time.Patients rinse for 2 minutes.The time interval between the two series of mouthwashes is set to 15 minutes. Intervention 2: Intervention group:Intervention group (B) receives 10% sodium bicarbonate solution every 8 hours 2 times. Patients rinse for 2 minutes.The time interval between the two series of mouthwashes is set to 15 minutes. Intervention 3: Control group:The control group (placebo) receives 10 cc of sterile water solution twice every 8 hours.Patients rinse for 2 minutes.The time interval between the two series of mouthwashes is set to 15 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 No information available
public Fateme Mohammadi
Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services
Hamedan Iran (Islamic Republic of) 6517838698 +98 81 3334 5634 F-mohammadi@umsha.ac.ir Hamedan University of Medical Sciences scientific Fateme Mohammadi
Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services
Hamedan Iran (Islamic Republic of) 6517838698 +98 81 3334 5634 F-mohammadi@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) • Patients with cancer aged 18-65 years • Stage I and II of Cancer • Under chemotherapy • With no oral ulcer • To be able to carry out a mouthwash • Having a normal level of white blood cells and platelets • Not using another medication to prevent and treat oral mucositis • Not being in pregnancy and lactation time • Not receiving chemotherapy and radiotherapy simultaneously • No other physical and mental disorders • Insensitivity to zinc chloride and sodium bicarbonate • Receiving at least one drug from the category of commonly used chemotherapy drugs • Not receiving chemotherapy drugs which increase mucositis, such as actinomycin and ... 18 years 65 years Both • Absence in at least one session of determined days for treatment follow-up • Hypersensitivity to zinc chloride and sodium bicarbonate • Extensive disability and weakness of the patient D01 Carcinoma in situ of other and unspecified digestive organs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Intervention group (A)Receives 10% zinc chloride solution 2 times every 8 hours and 10 cc each time.Patients rinse for 2 minutes.The time interval between the two series of mouthwashes is set to 15 minutes. Intervention group:Intervention group (B) receives 10% sodium bicarbonate solution every 8 hours 2 times. Patients rinse for 2 minutes.The time interval between the two series of mouthwashes is set to 15 minutes. Control group:The control group (placebo) receives 10 cc of sterile water solution twice every 8 hours.Patients rinse for 2 minutes.The time interval between the two series of mouthwashes is set to 15 minutes. Treatment of oral mucositis. Timepoint: 1 day before the intervention and 1, 4, 7 and 14 days after the intervention. Method of measurement: Visual Analogue Scale, Oral mucositis index, World Health Organization criteria for grading of oral mucositis. Hamedan University of Medical Sciences Approved 2020-10-24 Research ethics committee of Hamedan University of Medical Sciences Beginning of Khajeh Rashid Blvd, Hamedan University of Medical Sciences Hamedan Hamadan Iran (Islamic Republic of)