Evaluation of the Effect of Using Mouthwash Solution Containing Hydroalcoholic Extract of Pomegranate and Turmeric on Oral Mucositis Due to Chemotherapy in Cancer Patients, a Triple blind, Randomized, Controlled Trial

The effect of pomegranate and turmeric mouthwash on chemotherapy-induced mucositis

Clinical trial with control group, with parallel groups, three-way blind, randomized, phase 2 on 60 patients.A table of random numbers is used for randomization.

The study will be performed on 60 patients undergoing chemotherapy at Shahid Rahimi Hospital in Khorramabad. The control group continued with placebo mouthwash and the intervention group continued with pomegranate and turmeric mouthwash. Both groups also accepted routine treatment. It was then tested by a specific person on days 0, 7 and 14 of the intervention. In order to blind the researcher and other people involved in the study, the random grouping of participants will be assigned to one of the nurses, and in order to blind the patients, the mouthwash will contain the same extract and placebo.

Inclusion criteria: Patients 18 to 65 years Patients are able to complete the questionnaire Absence of serious dental problems and damage to the oral mucosa Do not use dentures Do not use anti-inflammatory and other mouthwash solutions during research No other systemic diseases No history of smoking, drugs and alcohol No oral candidiasis or herpes simplex Do not use cryotherapy for six weeks before the study Exclusion criteria: Patient dissatisfaction History of allergies to turmeric and pomegranate, lidocaine, antacids, diphenhydramine and dexamethasone Inability of the patient to implement the treatment protocol Patient death due to failure to respond to anticancer therapy Combination therapies such as radiation therapy

Intervention group: routine mouthwash plus mouthwash containing pomegranate and turmeric extract Control group: routine mouthwash plus placebo mouthwash

Degree of mucositis

Samples are used by stratified random blocking method (classes are intended to match the two groups in terms of disease grades so that patients with grade 1 and 2 in one class and patients with grade 3 and 4 in the other class) to two) An equal group of control and intervention will be assigned. The method of allocating samples to the two groups will be that considering the mucosal grade as a class, the method of 4 random blocks will be used to assign patients to two groups A (intervention) and group B (control). To do this, first write a list of blocks and assign numbers to them. (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)) Then using From the table of random numbers and randomly selected numbers between 1 and 6 and finally the list of treatment allocation will be formed based on a sequence of letters A and B.

This is a Triple-Blind Study and the blinding method is such that the researcher and the participating patients and data analyst will be unaware of which participant is in which group. In order to blind the researcher, random grouping of participants and prescribing mouthwash to them will be assigned to one of the ward doctors or nurses who has no role in the trial. In order to blind the participating patients, mouthwash containing extract and placebo mouthwash will taste as much as possible. And will have a similar appearance and will be prescribed in identical bottles. None of the members of the Data Safety and Supervision Committee, as well as the person evaluating the outcome and analyzing the data, will have a role in the randomization and use of mouthwash by participating patients and will not be informed which mouthwash each patient will use.