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IRCT20200721048159N5 IRCT 2021-12-29 Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences Antioxidant effects of crocin in patients undergoing angiography Evaluation of the Effect of Crocin on Oxidative Stress Biomarkers in Patients under Angiography with Contrast Agents: A Randomized Controlled Clinical Trial 2021-09-22 anticipated 80 Complete https://irct.ir/trial/58242 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be divided into two groups using the stratified blocked randomization method. In this way, considering the gender (female, male), a stratum will be formed and within this stratum, the samples in the form of four blocks will be randomly assigned to the desired groups. 3 contrast induced acute kidney Injury. Intervention 1: Control group: normal saline 1ml/kg from 6 hours before to 6 hours after administration of contrast agent. Intervention 2: Intervention group: normal saline 1ml/kg from 6 hours before to 6 hours after administration of contrast agent + 30mg/day crocina (Two tablets containing 15 mg of purified crocin from Poyesh Sina Pharmaceutical Company ) form the night before receiving contrast agent to the second night after reviving contrast agent. 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 There is no more information.
public Forouzan Ahmadpour
Shahid Ayatullah Madani Hospital, Khairabad Street, Shaghayegh Square, Khorramabad, Lorestan
Khorramabad Iran (Islamic Republic of) 6814713115 +98 66 3341 9123 ahmadpourforoz@yahoo.com Khoram-Abad University of Medical Sciences scientific Forouzan Ahmadpour
Faculty of Pharmacy, Lorestan University of Medical Sciences, , 3 km of Khorramabad-Tehran Road, Pardis University Complex, Khorramabad, Lorestan
Khorramabad Iran (Islamic Republic of) 6814713115 +98 66 3341 9123 ahmadpourforoz@yahoo.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) patient consent to enter to the study being candidate for angiography being over 18 years old systolic pressure of greater than 90 mm Hg 18 years no limit Both patient's tendency to exit from the study having Anaphylactic and anaphylactoid reactions during contrast media administration consumption of common antioxidant medicines in less than one week before use of contrast media and angiography consumption of nephrotoxic medicines (aminoglycosides, vancomycin and others) in less than one week before use of contrast media and angiography unstable kidney status or need of kidney transplantation impossibility of intravenous hydration for the patient consumption of Warfarin pregnancy and breastfeeding history of hypersensitivity to saffron history of hypersensitivity to contrast media participate in other clinical trials that their results may confound this intervention at least for a 28 days period N17.8 Other acute kidney failure Prevention Prevention Control group: normal saline 1ml/kg from 6 hours before to 6 hours after administration of contrast agent Intervention group: normal saline 1ml/kg from 6 hours before to 6 hours after administration of contrast agent + 30mg/day crocina (Two tablets containing 15 mg of purified crocin from Poyesh Sina Pharmaceutical Company ) form the night before receiving contrast agent to the second night after reviving contrast agent Serum creatinine. Timepoint: before getting medical regime and 24 and 48 hours after getting contrast media. Method of measurement: patient's medical file. Blood urea nitrogen. Timepoint: Before getting medical regime and 24 and 48 hours after getting contrast media. Method of measurement: Laboratory kit. Superoxide dismutase. Timepoint: Zero hours before getting medical regime of study and 4 hours after getting contrast media. Method of measurement: Laboratory kit. Malondialdehyde. Timepoint: Zero hours before getting medical regime of study and 4 hours after getting contrast media. Method of measurement: Laboratory kit. Catalase. Timepoint: Zero hours before getting medical regime of study and 4 hours after getting contrast media. Method of measurement: Laboratory kit. Glutathione proxidase. Timepoint: Zero hours before getting medical regime of study and 4 hours after getting contrast media. Method of measurement: Laboratory kit. Reactive oxygen species. Timepoint: Zero hours before getting medical regime of study and 4 hours after getting contrast media. Method of measurement: Laboratory kit. Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences Approved 2021-08-17 Ethics Committe of Lorestan University of Medical Sciences Office of Research Ethics Committee, Vice Chancellor for Research and Technology, Lorestan University of Medical Sciences, 3 km of Khorramabad-Tehran Road, Pardis University Complex, Khorramabad, Lorestan Khorramabd Lorestan Iran (Islamic Republic of)