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IRCT20190810044500N17 IRCT 2021-08-13 Yazd University of Medical Sciences Effect of curcumin on radiation induced mucositis Effect of curcumin on radiation induced mucositis 2021-08-23 anticipated 45 Complete https://irct.ir/trial/46869 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients were randomly assigned to three groups of 20 curcumin mouthwash, curcumin tablets, and placebo by the permuted block method. Treatment assignments within blocks are determined so that they are random in order but that the desired allocation proportions are achieved exactly within each block. 12 blocks of 5 are considered. Generation of random codes using Permuted Block Randomization method will be done with the help of Random allocation software (version 1). The first person who is eligible to enter the study is given number one and likewise, the last eligible person is given number 60. By using the software-generated table, patients receive each intervention (A or B or C). In order to consider blinding in random allocation, the list is given to another person outside the study and using short message service (SMS) before assigning the type of treatment according to the number of eligible people is asked and thus people enter the study, Blinding description: The steps will be covered by the assessor. The first presenter identifies the sequence of assignments of patients according to the order of entry of the patients into the study and identifies them with A or B or C codes. The student then delivers the drugs to each individual patient. 2-3 Mucositis. Intervention 1: Intervention group1: patients will be received 0.1% curcumin mouthwash 3 times a day for 3 weeks. Intervention 2: Intervention group 2: patients will be received curcumin capsule 40 mg per day for 3 weeks. Intervention 3: Control group: patients will be received placebo mouthwash 3 times a day for 3 weeks. 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 No more information
public shiva ghadirian abarghoyi
Shahid Sadoughi Medical Sciences Campus, Professor Hesabi Blvd.
yazd Iran (Islamic Republic of) 8917885976 +98 35 3822 9801 shiva_gh_73@yahoo.com Yazd University of Medical Sciences scientific Fateme Saghafi
Shahid Sadoughi University of Medical Sciences, Shohaday Gomnam blvd.
Yazd Iran (Islamic Republic of) 8915173143 +98 35 3820 3419 Saghfi.Fa@gmail.comhs Yazd University of Medical Sciences Iran (Islamic Republic of) Patients with mucositis caused by radiotherapy and chemotherapy Get at least a dose of 50 gray of radiation during the study At least two parts of the mouth are involved 18 years 65 years Both Patients with certain diseases Unwillingness to continue participating in the study smoking Serious dental problems, bruising teeth and the presence of sharp fillings Presence of artificial teeth importing trauma Severe systemic disease such as uncontrolled diabetes With the start of radiation therapy, the patient should be treated by a physician other than for the usual treatment for mucositis. Simultaneous treatment with Target therapy drugs Infection K12. 30 Diseases of the digestive system Treatment - Drugs Treatment - Drugs Placebo Intervention group1: patients will be received 0.1% curcumin mouthwash 3 times a day for 3 weeks Intervention group 2: patients will be received curcumin capsule 40 mg per day for 3 weeks Control group: patients will be received placebo mouthwash 3 times a day for 3 weeks Oral wound size. Timepoint: Before the intervention, after completion of the intervention. Method of measurement: Clinical examination. Pain or burning sensation in the mouth. Timepoint: Before intervention, after intervention. Method of measurement: Clinical examination and patient based on VAS criteria. Redness. Timepoint: Before intervention, after intervention. Method of measurement: Clinical examination and patient based on VAS criteria. Yazd University of Medical Sciences Approved 2020-09-13 Insitutional research Ethics Committee School of Medicine, Shahid Sadoughi University of Medical Sci Shahid Sadoughi University of Medical Sciences, Shohaday Gomnam blvd. Yazd Yazd Iran (Islamic Republic of)