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IRCT20220429054699N1 IRCT 2023-10-19 Esfahan University of Medical Sciences Improving effect of Curcumin on Chemoradiotherapy-Induced Enteritis of colorectal cancer: a randomized, double-blinded, placebo-controlled study Improving effect of Curcumin on Chemoradiotherapy-Induced Enteritis of colorectal cancer: a randomized, double-blinded, placebo-controlled study 2017-04-05 anticipated 56 Complete https://irct.ir/trial/63269 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Since this study is a double-blind clinical trial neither the main researcher nor the participants should know about the placement of people in the intervention and control groups. Therefore, in this study, a third person (outside the study) was asked to divide the selected people into two groups of the same size using random allocation software v.2. In this way, first, the list of people eligible to enter the study is entered into the random allocation software, the number of groups is defined for the software (2 groups, intervention, and control), and the sample size of each group is also entered (n=28). The software randomly assigns the samples to 2 groups with the same sample size, and the list of people in the two groups is kept by a third party (outside the study), Blinding description: Since this study is double-blind, neither the main researcher nor the participants knew about the placement of the samples in the intervention categories. The intervention was done by a third person outside the study. Necessary explanations were given to them by the main researcher. The medicine capsule and placebo (formula) were completely identical in terms of size, shape and color, and only the third person (outside the study and having expertise in the field of study) knew whether it was a medicine or not. The first group (intervention) was given 500 mg curcumin daily and the control group (placebo) was given a similar capsule without medicine. Every two weeks, demographic information and clinical symptoms and signs of enterocolitis of both groups were collected by a third person and provided to the researcher. 2-3 RECTAL CANCER. Intervention 1: Intervention group: Curcumin is a medicine to reduce inflammation. In this study, we intended to measure its effect on enterocolitis caused by radiation therapy. Therefore, from the first day for 25-28 days (depending on the patients' radiotherapy time), we considered a daily dose of 500 mg (standard curcumin capsules) for people undergoing chemotherapy. The drugs were given to the patients daily at a particular time (how many hours after chemotherapy?). This medicine was taken orally. This drug is a product of Karen Pharmaceuticals and Vital Food Supplements Company. Its ingredients include 500 mg of turmeric extract (475 mg of curcuminoids). Intervention 2: Control group: We used a capsule similar to the main drug (placebo) in the control group. This group also received a daily capsule similar to the intervention group. The treatment duration and consumption method were identical to the intervention group. Yes - There is a plan to make this available What will be shared: number of side effects When: of 2018 To whom: Researchers Conditions: all kinds of analysis Where to obtain: Seyed alshohada Hospital How to obtain: The phone call is then approved by the researcher and the ethics committee Comments:
public Ali Ebrahimi
motahari street
Isfahan Iran (Islamic Republic of) 8188633111 +98 913 308 0828 aalliiee50@yahoo.com Esfahan University of Medical Sciences scientific Nadia Najafizahe
Motahari Street
Isfahan Iran (Islamic Republic of) 8188633111 +98 31 3235 0214 aalliiee50@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Rectal cancer Indication of chemo-Radiation 20 years no limit Male Hypersensitivity to traumatic C20 Malignant neoplasm of rectum Treatment - Drugs Placebo Intervention group: Curcumin is a medicine to reduce inflammation. In this study, we intended to measure its effect on enterocolitis caused by radiation therapy. Therefore, from the first day for 25-28 days (depending on the patients' radiotherapy time), we considered a daily dose of 500 mg (standard curcumin capsules) for people undergoing chemotherapy. The drugs were given to the patients daily at a particular time (how many hours after chemotherapy?). This medicine was taken orally. This drug is a product of Karen Pharmaceuticals and Vital Food Supplements Company. Its ingredients include 500 mg of turmeric extract (475 mg of curcuminoids). Control group: We used a capsule similar to the main drug (placebo) in the control group. This group also received a daily capsule similar to the intervention group. The treatment duration and consumption method were identical to the intervention group. Chemo radiation side effect. Timepoint: weekly. Method of measurement: Visiting and filling out the Criteria for Adverse Events of intestinal form. Esfahan University of Medical Sciences Approved 2017-06-06 Ethics committee of Isfahan University of Medical Sciences Hezar jarib Isfahan Isfehan Iran (Islamic Republic of)