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IRCT20130211012438N32 IRCT 2020-08-23 Kashan University of Medical Sciences Effect of Honey- Ginger mouthwash on Oral Mucositis in Patients under Chemotherapy Effect of Honey- Ginger mouthwash on Oral Mucositis in Patients under Chemotherapy in Kashan Shahid Beheshti Hospital in 2020 2020-09-15 anticipated 80 Complete https://irct.ir/trial/48573 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Prevention, Randomization description: This intervention is a type of double-blind clinical practice and will use clinical examination and study of patients' files (manual and electronic) to collect data. With the permission of Kashan University of Medical Sciences and the approval of the ethics committee, 80 patients will be selected from the eligible patients and will be assigned to two control and intervention groups (ginger mouthwash) with the help of block randomization model with 4 and 6 blocks, Blinding description: 1) In pharmaceutical bottles, a certain amount of ginger is used to homogenize its taste with mouthwash. 2) Bottles used for placebo and mouthwash are dark in color to hide the contents of the bottles. 3) Bottles containing mouthwash and placebo are marked in the absence of the researcher. 3 Oral Mucositis in Patients under Chemotherapy. Intervention 1: Intervention group: the oral intervention group receives 4% ginger extract and 7% honey obtained from the Biochemistry and Nutrition Research Center of Kashan University of Medical Sciences and rinses twice a day for 2 weeks, 3 times a day for 2 tablespoons for 1 minute each. Intervention 2: Control group: the oral intervention group receives 9% normal saline (Iran Injection and Pharmaceutical Products Company) and rinses twice a day for 2 weeks, 3 times a day for 2 tablespoons for 1 minute each. Yes - There is a plan to make this available What will be shared: Only part of the data, such as pain severity, mucositis severity, age, sex, and type of disease, can be disseminated When: Start the access period 6 months after printing the results To whom: It will only be available to researchers working in academic and scientific institutions Conditions: Analyzes related to promoting the scientific awareness of researchers and helping modern science are allowed Where to obtain: fateme sadat razavi,09017336138,fatemee.razavii1994@gmail.com How to obtain: An applicant can send a request for a data file by e-mail. After reviewing the request, the data file will be sent to him/her after about three weeks would have passed from the date of the request Comments:
public Elahe Ghasem Zade Hosseini
Kashan, Qutb Ravandi Boulevard
kashan Iran (Islamic Republic of) 8715981151 55578010 fatemee.razavii1994@gmail.com Kashan University of Medical Sciences scientific Dr elahe qasemzade hosseini
Kashan, Qutb Ravandi Boulevard
kashan Iran (Islamic Republic of) 8715981151 55578010 el.qasemzade@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Having chemotherapy-induced mucositis Agree to participate in the study The patient must be at least 18 years old Patients have a definitive diagnosis of cancer (histological confirmation) Oral hygiene No history of allergies (asthma, allergic rhinitis) Patients without systemic problems weaken the immune system Absence of allergic diseases 18 years no limit Both Patients who received radiation therapy during the intervention Announcing the patient's non-cooperation at any stage of the project Patients who received local anesthetic during the study Use another mouthwash during the study Patients who refused to quit smoking and did not eat spicy, acidic or spicy foods. Patients with severe systemic problems (uncontrolled diabetes, advanced liver and kidney disease) K12.31 Oral mucositis (ulcerative) due to antineoplastic therapy Treatment - Drugs Placebo Intervention group: the oral intervention group receives 4% ginger extract and 7% honey obtained from the Biochemistry and Nutrition Research Center of Kashan University of Medical Sciences and rinses twice a day for 2 weeks, 3 times a day for 2 tablespoons for 1 minute each. Control group: the oral intervention group receives 9% normal saline (Iran Injection and Pharmaceutical Products Company) and rinses twice a day for 2 weeks, 3 times a day for 2 tablespoons for 1 minute each. The severity of the pain. Timepoint: Before Intervention and day 7 and day14. Method of measurement: The VAS scale is given from zero to 10. The severity of the mucositis. Timepoint: Before Intervention and day 7 and day14. Method of measurement: Based on WHO mucositis evaluation criteria. . Timepoint: . Method of measurement: . Kashan University of Medical Sciences Approved 2020-05-19 Ethics committee of kashan University of Medical Sciences Qutb Ravandi Boulevard, Kashan University of Medical Sciences kashan Isfehan Iran (Islamic Republic of)