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IRCT20180923041093N1 IRCT 2018-12-02 Vice chancellor for research, Kerman university of medical sciences Effect of spaghula husk mucilage on prevention of chemotherapy-induced mucositis Evaluation of the effect of Persian medicine based preparation from spaghula (Plantago Ovata Forsk) husk mucilage on prevention and treatment of oral mucositis in breast cancer patients receiving adriamycin 2018-12-11 anticipated 20 Complete https://irct.ir/trial/33977 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Prevention, Randomization description: use of random numbers table, Blinding description: The drug and placebo will coded by a third person (A - B). Therefore, the patient, researchers and outcome evaluators do not know which patient is in the drug group and which patient is in the placebo group. After the completion of the sampling, the third person will offer the codes to the data analyzer. 3 Adriamycin induced oral mucositis. Intervention 1: Intervention group: A mixture of (500 ml ispaghula husk and 3 drops of vinegar in 30 cc water) should be kept in the mouth for 1 minute then poured out, three times a day . For 14 days. The intervention begins from the start of the Adriamycin Course and continues until the next course begins. Intervention 2: Control group: placebo: A mixture of (400 mg maltodextrin + 80 mg carbomer +20 mg cinnamon +3 drops of triethanolamine in 30 cc water) should be kept in the mouth for 1 minute then poured out, three times a day . For 14 days. The intervention begins from the start of the Adriamycin Course and continues until the next course begins. Yes - There is a plan to make this available What will be shared: All data will be shared through a supplementary file after unidentified individuals. When: Start the access period from 6 months after printing results To whom: Researchers and other people can access data if they need it. Conditions: For use in review articles, reprogramming and modeling can be used in other studies. In case of need, should be emailed to the programmer. Where to obtain: Executor of plan or University How to obtain: Email the scheduler (Dr.Setayesh) ,he answers. Comments: All information is available to others for the advancement of science.
public Fatemeh Sadat Hasheminasab
Faculty of Traditional Persian Medicine, Amir Kabir crossroad
Kerman Iran (Islamic Republic of) 7618843883 +98 34 3211 0860 hashemifa67@gmail.com Kerman University of Medical Sciences scientific Mohammad Setayesh
Faculty of Traditional Persian Medicine, Amir Kabir crossroad
Kerman Iran (Islamic Republic of) 7618843883 +98 34 3211 0860 msetayeshmail@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Breast cancer Candidate for adriamycin mucositis in screening course Remaining two courses of adriamycin with two weeks interval Age between 17 and 65 years Life expectancy for more than a year based on physician or team estimates Physical and mental ability to cooperate in filling in the questionnaire The desire to participate in the study 17 years 65 years Both Use alcohol Use of drugs that affect salivary glands such as antipsychotics, opioids, antihypertensives, antihistamine, diuretics Use of mouthwashes and artificial saliva and cigarettes Receiving Early Radiation in mouth or oropharynx The history of connective tissue diseases, such as Sjogren, rheumatoid arthritis, lupus Liver and kidney disease Major Depression Diseases that affect salivary glands such as diabetes Diseases that induce dehydration such as chronic diarrhea Diseases of the immune system Recurrent aphthous stomatitis Receiving Lithium or Levothyroxine for interference with spaghula K12.31 Oral mucositis (ulcerative) due to antineoplastic therapy Treatment - Drugs Placebo Intervention group: A mixture of (500 ml ispaghula husk and 3 drops of vinegar in 30 cc water) should be kept in the mouth for 1 minute then poured out, three times a day . For 14 days. The intervention begins from the start of the Adriamycin Course and continues until the next course begins. Control group: placebo: A mixture of (400 mg maltodextrin + 80 mg carbomer +20 mg cinnamon +3 drops of triethanolamine in 30 cc water) should be kept in the mouth for 1 minute then poured out, three times a day . For 14 days. The intervention begins from the start of the Adriamycin Course and continues until the next course begins. Degree of oral mucositis according to WHO scale. Timepoint: Precisely before the intervention, 7 days after the start of intervention and 14 days after the start of intervention (the last day of the intervention). Method of measurement: WHO scale for oral mucositis. Degree of pain due to oral mucositis. Timepoint: Precisely before the intervention, 7 days after the start of intervention and 14 days after the start of intervention (the last day of the intervention). Method of measurement: Visual Analogue Scale. Quality of life. Timepoint: Precisely before the intervention, 7 days after the start of intervention and 14 days after the start of intervention (the last day of the intervention). Method of measurement: OHIP-14 questionnaire. Xerostomia. Timepoint: Precisely before the intervention, 7 days after the start of intervention and 14 days after the start of intervention (the last day of the intervention). Method of measurement: LENT-SOMA scale. Vice chancellor for research, Kerman university of medical sciences Approved 2018-09-30 Ethics committee of Kerman university of medical sciences Beginning of Ibn Sina Street, Beginning of Jihad Blvd., Somayeh Road (Tahmasebabad), Kerman Kerman Kerman Iran (Islamic Republic of)