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IRCT20210228050519N1 IRCT 2021-12-27 Arak University of Medical Sciences The effect of three-component mouthwash (nystatin, aluminum MGS and diphenhydramine), chamomile and mucosamine spray in the treatment of oral mucositis caused by chemotherapy Evaluation of the effect of three compounds (nystatin, aluminum ammonia, and diphenhydramine), mouthwash, chamomile, and mucosamine spray in the treatment of chemotherapy-induced oral mucositis in malignancy in children with leukemia 2021-12-21 anticipated 90 Complete https://irct.ir/trial/54832 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All children are admitted to the study according to the inclusion criteria and sampling is done in an accessible and easy way. In this study, randomized block method will be used to randomize the three groups of routine treatment (group A), chamomile mouthwash treatment (group B) and mucosamine spray treatment (group C). Children will be divided into three equal groups (A / B / C) using random allocation. In order to perform random allocation, the randomized blocking method with 6 blocks such as AABBCC, ABBACC, BBAACC, AACCBB, BBCCAA, ACBCAB, etc. will be used, which will have numbers from 1 onwards. Then, by randomly selecting numbers from 1 to n, random sequences of three types of drugs will be identified for the studied samples, Blinding description: In this study, the statistical expert and the evaluator of the outcome are not aware of the type of drug used, so the study is double-blind. 3 Severity of oral mucositis. Intervention 1: Intervention group: Before starting chemotherapy, all subjects will be taught the correct way to observe oral hygiene, including brushing and flossing. All participants received a three-combination mouthwash (nystatin, aluminum ammojas, and diphenhydramine) as a routine treatment for such children who rolled for 1 minute once a day in the morning (receiving daily mouthwash until the 14th day). After mouthwash, patients do not consume food or fluids for up to 1 hour (group A). Intervention 2: Intervention group: • In the chamomile group, use chamomile mouthwash available in pharmacies for a week, three times a day (morning, noon, night) after brushing. Dilute 15 drops of the solution in 10 cc of water and gargle for one minute and do not eat for an hour after that, and the previous standard treatment of the treating physician will continue except for the use of topical mouthwash (group B). (Receive daily mouthwash until the 14th day). Intervention 3: In the mucosamine group (water, sodium, glanzine, propylene glycol, lysine, leucine and proline) in addition to the three-combination mouthwash, mucosamine is sprayed 3 times a day on the entire mucous membrane of the patient's mouth (group C) (spray received) Daily until the 14th day). No drug interactions have been reported for this drug. 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 I have not decided yet
public Khalil Namazi
Payambar aazam (SAW) University Complex Basij Square of the University Complex
Arak Iran (Islamic Republic of) 3819693345 +98 914 451 3811 namazikhalil44@gmail.com Arak University of Medical Sciences scientific khalil namazi
Payambar aazam (SAW) University Complex Basij Square of the University Complex
arak Iran (Islamic Republic of) 3819693345 +98 914 451 3811 namazikhalil44@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Full consciousness Hospitalized in the oncology ward of Arak Children's Hospital No gum disease Lack of continuous use of painkillers and drugs Similar treatment protocol Minimum age 2 years and maximum 16 years Having oral mucosa (minimum score 1) No history of chamomile mouthwash and mucosamine spray 2 years 16 years Both Improvement of oral mucosa before randomization K12.3 موکوزیت دهانی Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Before starting chemotherapy, all subjects will be taught the correct way to observe oral hygiene, including brushing and flossing. All participants received a three-combination mouthwash (nystatin, aluminum ammojas, and diphenhydramine) as a routine treatment for such children who rolled for 1 minute once a day in the morning (receiving daily mouthwash until the 14th day). After mouthwash, patients do not consume food or fluids for up to 1 hour (group A). Intervention group: • In the chamomile group, use chamomile mouthwash available in pharmacies for a week, three times a day (morning, noon, night) after brushing. Dilute 15 drops of the solution in 10 cc of water and gargle for one minute and do not eat for an hour after that, and the previous standard treatment of the treating physician will continue except for the use of topical mouthwash (group B). (Receive daily mouthwash until the 14th day). In the mucosamine group (water, sodium, glanzine, propylene glycol, lysine, leucine and proline) in addition to the three-combination mouthwash, mucosamine is sprayed 3 times a day on the entire mucous membrane of the patient's mouth (group C) (spray received) Daily until the 14th day). No drug interactions have been reported for this drug Severity of oral mucositis. Timepoint: On the first day (before the intervention), the seventh day and the fourteenth day. Method of measurement: Mucosal severity instrument with a scoring range of 0 to 4. Arak University of Medical Sciences Approved 2021-10-17 Ethics committee of Arak University of Medical Sciences Payambar aazam (SAW) University Complex, Basij SQ, Sardasht region Arak Markazi Iran (Islamic Republic of)