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IRCT20190918044815N1 IRCT 2020-09-21 Esfahan University of Medical Sciences Evaluation of curcumin effect on prevention of hepatotoxicity Evaluation of curcumin effect on prevention of hepatotoxicity induced by chemotherapeutic drugs in patients under outpatient canecr treatment 2020-02-20 anticipated 60 Complete https://irct.ir/trial/49666 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, randomization was performed using random allocation software. The randomization method was of permutation block type with blocks of volume 4. For each person who entered the study, a code was obtained from the software and it was determined which group it belongs to (intervention or control), Blinding description: This is a double blinded study.in this study patients,outcome evaluator and statistical analyzer are blind.each patient is belong to group A or B and only the researcher knows which group is intervention group and which is control group. 3 cancer. Intervention 1: Intervention group: At first, 30 people were randomly selected from permutation block and received a 450 mg curcumin tablet daily and at intervals before the intervention, 3 and 6 weeks after the intervention, ALT, AST, BILIRUBIN, ALP tests by A laboratory that does not know the groups will be checked and the hepatotoxicity determined by the increase of each of these enzymes from the normal range will be recorded. Intervention 2: Control group: First, 30 people are randomly selected from the permutation block type and receive one placebo pill daily. At intervals before the intervention, 3 and 6 weeks after the intervention, ALT, AST, BILIRUBIN, ALP tests are checked by a laboratory that does not know the groups, and the hepatotoxicity is determined by increasing each of these enzymes from the normal range. Will be registered. 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 due to financial support of Isfahan university of medical sciences the decision regarding the publication of data is at the disposal of this organization.
public Ali Hajgholami
Isfahan university of medical sciences,Hezarjarib Ave, Daneshgah Blvd
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 2225 5658 sohrab137347@gmail.com Esfahan University of Medical Sciences scientific Ali Hajigholami
Isfahan university of medical sciences,Hezarjarib Ave, Daneshgah Blvd,
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3225 2589 sohrab137347@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Age 30 to 60 years Definitive diagnosis of cancer that chemotherapyeutic treatment is indicated . Treated with a regimen containing paclitaxel and docetaxel Ability to take oral medication 30 years 60 years Both Gastrointestinal bleeding pregnancy and Breastfeeding using heparin, aspirin, Clopidogrel, dipiridamol ,warfarin and ticlopidine Past medical history of hepatic disease Past medical history of peptic ulcer C50.1 Malignant neoplasm of central portion of breast Treatment - Drugs Placebo Intervention group: At first, 30 people were randomly selected from permutation block and received a 450 mg curcumin tablet daily and at intervals before the intervention, 3 and 6 weeks after the intervention, ALT, AST, BILIRUBIN, ALP tests by A laboratory that does not know the groups will be checked and the hepatotoxicity determined by the increase of each of these enzymes from the normal range will be recorded. Control group: First, 30 people are randomly selected from the permutation block type and receive one placebo pill daily. At intervals before the intervention, 3 and 6 weeks after the intervention, ALT, AST, BILIRUBIN, ALP tests are checked by a laboratory that does not know the groups, and the hepatotoxicity is determined by increasing each of these enzymes from the normal range. Will be registered. Aspartate Aminotransferase. Timepoint: before intervention and 3 and 6 weeks after intervention. Method of measurement: laboratory. Alanine transaminase. Timepoint: before intervention and 3 and 6 weeks after intervention. Method of measurement: laboratory. Alkaline phosphatase. Timepoint: before intervention and 3 and 6 weeks after intervention. Method of measurement: laboratory. Bilirubin. Timepoint: before intervention and 3 and 6 weeks after intervention. Method of measurement: laboratory. Esfahan University of Medical Sciences Approved 2020-02-14 Ethics committee of Isfahan university of medical sciences Hezarjarib Ave Isfahan Isfehan Iran (Islamic Republic of)