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IRCT20191104045328N12 IRCT 2022-08-10 Islamic Azad University Comparison of the effect of chamomile and gelclair on chemotherapy-induced oral mucositis Comparison of the effect of chamomile and gelclair on chemotherapy-induced oral mucositis in children with cancer 2022-08-16 anticipated 50 Complete https://irct.ir/trial/63858 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants are assigned to two intervention and control groups, respectively, based on the randomization sequence that will be generated beforehand. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 8 blocks will be used to allocate samples. Thus, using block numerical random number generation software, a randomization sequence proportional to the sample size required for the two groups will be generated. Initially, all cases in which the two letters A and B can be arranged in blocks of 8 are produced. A block is then randomly selected from the blocks and the layout pattern in that block will be used to assign participants. This block will then be placed in the main container and another block will be selected again. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups. In fact, the researcher will not be able to predict which group the next person will be in. 2-3 Oral mucositis. Intervention 1: Intervention group: Patients receive chamomile tea 6 times a day (every 4 hours) for 2 weeks. Intervention 2: Intervention group: they receive Clear gel 4 times a day for 2 weeks. Yes - There is a plan to make this available What will be shared: After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study. When: Access will be from 2023/4/20 to 2026/4/20 for 3 years. To whom: University researchers Conditions: Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study. Where to obtain: University researchers and university professors, after contacting the relevant professor by text message or e-mail, can request the use of data from Dr. Ramezani and then Dr. falahati, respectively. Dr. Elham Ramezani: Address: Qom, 15 Khordad Blvd., near Social Security Insurance, Islamic Azad University of Qom, Faculty of Medicine, Research Assistant. Postal Code: 3714668669 Phone: 09123519544 Email: Elham96261@gmail.com Dr. Vahid Falahati Address: Hospital Education Vice-Chancellor, Amirkabir Hospital, Arak Postal Code: 3814957558 Phone: 09133065573Email: vahidfalahati@arakmu.ac.ir How to obtain: Letter writing should be done with professors and universities. Comments:
public Dr. Elham Ramezani
Qom, 15 Khordad Blvd., near Social Security Insurance, Islamic Azad University of Qom, Faculty of Medicine, Research Assistant
Qum Iran (Islamic Republic of) 3714668669 +98 25 3778 0001 Elham96261@gmail.com Iran University of Medical Sciences scientific Dr. Vahid Falahati
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
Arak Iran (Islamic Republic of) 3819691187 +98 86 3222 2003 vahidfalahati@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Children with cancer between the ages of 2 and 15 who were referred to the oncology department of Amirkabir Arak Hospital within 3 months Consent to participate in the study 2 years 15 years Both History of drugs allergy Presence of chronic mucous skin disease K12.3 Oral mucositis (ulcerative) Treatment - Drugs Treatment - Drugs Intervention group: Patients receive chamomile tea 6 times a day (every 4 hours) for 2 weeks. Intervention group: they receive Clear gel 4 times a day for 2 weeks. The severity of mucositis. Timepoint: 1st, 7th and 14th day of treatment. Method of measurement: Physical examination. Islamic Azad University Approved 2022-04-19 Ethics Committee of Qom University of Medical Sciences Qom, 15 Khordad Blvd., near Social Security Insurance, Islamic Azad University of Qom, Faculty of Medicine, Research Assistant Arak Markazi Iran (Islamic Republic of)