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IRCT20090613002027N17 IRCT 2019-09-28 Mazandaran University of Medical Sciences Evaluation of the effects of Aloe Vera Ointment in the radiation induced Proctitis in prostate cancer patients Comparison of the effects of the Effects of Aloe Vera and Placebo Ointment in the Prevention of Radiation-Induced Acute Proctitis in Prostate Cancer Patients 2019-01-10 anticipated 56 Complete https://irct.ir/trial/35065 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be randomized according to block randomization with 4 cases in each block. For concealment, a 5 digits unique code will be obtained from Excel, Blinding description: Aloe vera and placebo will be filled in identical containers, and the senior researcher will insert the unique code of each participant on the containers. The researcher and patient will not be aware of the type of intervention received. 3 Radiation-induced acute proctitis in prostate cancer patients. Intervention 1: Intervention group: Aloe Vera ointment 3% for the first day of radiotherapy every 12 hours, rectal use for 2 months. Intervention 2: Control group: Placebo of Aloe Vera ointment 3% for the first day of radiotherapy every 12 hours, rectal use for 2 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of patients data
public Ebrahim Salehifar
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar square, Sari, Mazandaran Province
Sari Iran (Islamic Republic of) 4818893716 +98 11 3354 3082 Esalehifar@Mazums.ac.ir Mazandaran University of Medical Sciences scientific Ebrahim Salehifar
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar square
Sari Iran (Islamic Republic of) 4818893716 +98 11 3354 3082 esalehifar@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Being over 18 years old Prostate cancer patients whom are under pelvic Radiotherapy 18 years no limit Male Evidence of active infection Evidence suggesting other causes of bloody diarrhea, such as colon cancer, inflammatory bowel disease and hemorrhoids Fecal Incontinence Anorectal fistula Anal Stenosis History of surgery in the rectum area Any known Sensitivity of the components used in the ointment Concomitant use of antibiotics, Glucocorticoids and Sulfonamide compounds K62.7 Radiation proctitis Prevention Placebo Intervention group: Aloe Vera ointment 3% for the first day of radiotherapy every 12 hours, rectal use for 2 months Control group: Placebo of Aloe Vera ointment 3% for the first day of radiotherapy every 12 hours, rectal use for 2 months Development of Proctitis. Timepoint: Before intervention, then every 2 weeks for eight weeks after intervention. Method of measurement: Based on clinical presentation. Proctitis severity. Timepoint: Before intervention, then every 2weeks for eight weeks after intervention. Method of measurement: Based on Radiation therapy oncology group (RTOG) and CTCAE–v5-2017 criteria. Social-Psychological state. Timepoint: Before intervention, then every 2weeks for eight weeks after intervention. Method of measurement: Based on Hospital Anxiety-Deprresion (HAD) scale. Quality of life. Timepoint: Before intervention, then every 2weeks for eight weeks after intervention. Method of measurement: Based on questionnaire defines the Quality of Life from 0 to 5. Mazandaran University of Medical Sciences Approved 2019-01-02 Ethics committee of Mazandaran University of Medical sciences Mazandaran University of Medical Scienses, kilometer 18 of Farah Abad road, Sari, Iran Sari Mazandaran Iran (Islamic Republic of)