]>
IRCT20200721048159N1 IRCT 2021-04-10 Khoram-Abad University of Medical Sciences Evaluation of the Effect of Pomegranate and Turmeric Mouthwash on Oral Mucositis Due to Chemotherapy 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 2021-05-17 anticipated 60 Complete https://irct.ir/trial/55134 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. N/A Oral mucositis due to antineoplastic therapy. Intervention 1: Intervention group: Intervention group Herbal mouthwash containing 6.25% hydroalcoholic extract of pomegranate peel and 0.1% hydroalcoholic extract of turmeric, once every 6 hours, 30 drops in water to reach a volume of 10 ml and hold in the mouth for 2 minutes and then gargle They will swallow. The patients will receive herbal mouthwash for a week in addition to routine treatment. Intervention 2: Control group: The control group poured 30 drops of placebo into the mouth every 6 hours until it reached a volume of 10 ml and was kept in the mouth for 2 minutes, then gargled and swallowed.The patients will receive placebo mouthwash for a week in addition to routine 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 more information
public Forouzan Ahmadpour
Kamalvand, 4 km of Khorramabad road
Khoramabad Iran (Islamic Republic of) 12467865432453 +98 66 3312 0239 ahmadpourforoz@yahoo.com Khoram-Abad University of Medical Sciences scientific Forouzan Ahmadpour
Kamalvand, 4 km of Khorramabad road
Khoramabad Iran (Islamic Republic of) 12467865432453 +98 66 3312 0239 ahmadpourforoz@yahoo.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Patients in the age range of 18 to 65 years Cancer patients with chemotherapy-induced oral inflammation Patients are able to complete a questionnaire and collaborate with the researcher Absence of serious dental problems or teeth damaging the oral mucosa or sharp fillings 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 (fungus) or herpes simplex (virus) Do not use cryotherapy for six weeks before the study 18 years 65 years Both Dissatisfaction with participating in the study Participate in another clinical trial at the same time 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 K12.31 Oral mucositis (ulcerative) due to antineoplastic therapy Treatment - Drugs Treatment - Drugs Intervention group: Intervention group Herbal mouthwash containing 6.25% hydroalcoholic extract of pomegranate peel and 0.1% hydroalcoholic extract of turmeric, once every 6 hours, 30 drops in water to reach a volume of 10 ml and hold in the mouth for 2 minutes and then gargle They will swallow. The patients will receive herbal mouthwash for a week in addition to routine treatment. Control group: The control group poured 30 drops of placebo into the mouth every 6 hours until it reached a volume of 10 ml and was kept in the mouth for 2 minutes, then gargled and swallowed.The patients will receive placebo mouthwash for a week in addition to routine treatment. Grade of mucositis based on WHO scale. Timepoint: Evaluation of grade of mucositis at the beginning of the study, 7 and 14 days after mouthwash containing pomegranate and turmeric extract. Method of measurement: Standard questionnaire and patient examination. Khorramabad University of Medical Sciences Approved 2021-03-09 Ethics Committee of Lorestan University of Medical Sciences Naser Khosrow Square, Roudaki St., Chaghervand Alley, No. 10 khorram abad Lorestan Iran (Islamic Republic of)