]>
IRCT20210413050958N2 IRCT 2021-12-18 Mashhad University of Medical Sciences Effect of curcumin on the prevention of contrast induced nephropathy The effects of curcumin on the prevention of contrast induced nephropathy: A randomized double blind clinical trial 2022-04-21 anticipated 227 Complete https://irct.ir/trial/60415 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The block randomization method will be used, so that blocks with size 4 of the combination of letters A and B (ABBA, ABAB, AABB, BAAB, BBAA, BABA) are selected to the required number using a table of random numbers and individuals are assigned to groups according to the created sequence, Blinding description: The random allocation sequence is made using the table of random numbers. Sequentially numbered sealed envelopes are used to implement the random allocation sequence which opened by a person not involved in the project. The participants, care providers and statistician are blinded after assignment to intervention. So that, the powders bottles are coded by a non-researcher person and remain confidential until data analysis. Moreover, In addition, placebo powder is similar to supplement powder in shape, weight and color. 3 Nephropathy induced by contrast agents. Intervention 1: Intervention group: In treatment group (n=227), curcumin is taken orally in subjects will be received from two days before I.V. contrast agent injection up to 48 hours after the intervention. Curcumin is provided by Sami Labs LTD company. Intervention 2: Control group: In the control group (n=227), placebo of the same shape, weight and color with drug will be taken orally by subjects from two days before I.V. contrast agent injection up to 48 hours after the intervention. Placebo is provided by Sami Labs LTD company. No - There is not a plan to make this available Justification or reason for not sharing IPD is Raw data will be shared upon a reasonable request from the corresponding author.
public Maryam Saberi-Karimian
Ahmadabad Street, Ghaem Hospital
Mashhad Iran (Islamic Republic of) 99199-91766 +98 51 3764 3808 maryamsabery2012@gmail.com Mashhad University of Medical Sciences scientific Maryam Saberi-Karimian
Ahmadabad Street, Ghaem Hospital
Mashhad Iran (Islamic Republic of) 99199-91766 +98 51 3840 0001 saberikm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) All subjects who receive IV. contrast agent (except renal artery angiography candidates) 18 years no limit Both Hepatic failure (Child-Pugh Score B or C) Biliary obstruction End-stage renal insufficiency (eGFR less than 15 mL/min) Acute renal insufficiency (BUN/Creatinine more than 20) A history of reaction to contrast media Taking potentially nephrotoxic medicines (48 h before and 24 h after the procedure) Pulmonary oedema Gastrointestinal disorders (such as diarrhea, vomiting, dehydration, bleeding, malabsorption, indigestion, etc.) Multiple myeloma Exposure to contrast media within 7 days before the procedure Pregnancy Taking N-acetyl cysteine, teofiline, dopamine, fenoldopam, manitol, and NaHCO3 within 48 h before coronary angiography. N14.1 Nephropathy induced by other drugs, medicaments and biological substances Prevention Placebo Intervention group: In treatment group (n=227), curcumin is taken orally in subjects will be received from two days before I.V. contrast agent injection up to 48 hours after the intervention. Curcumin is provided by Sami Labs LTD company. Control group: In the control group (n=227), placebo of the same shape, weight and color with drug will be taken orally by subjects from two days before I.V. contrast agent injection up to 48 hours after the intervention. Placebo is provided by Sami Labs LTD company. Increased serum creatinine level. Timepoint: Before the intervention and 48 hours after contrast agent injection. Method of measurement: Creatinine kit. Blood urea nitrogen. Timepoint: Before the intervention and 48 hours after contrast agent injection. Method of measurement: Blood urea nitrogen kit. Cell blood count. Timepoint: Before the intervention and 48 hours after contrast agent injection. Method of measurement: Sysmex Cell Counter. Creatinin. Timepoint: Before the intervention and 48 hours after contrast agent injection. Method of measurement: Serum creatinin kit. Mashhad University of Medical Sciences Approved 2021-11-16 Ethics committee of Mashhad University of Medical Sciences Research Council, Ghoreishi bildings, Daneshgah Ave. Mashhad Razavi Khorasan Iran (Islamic Republic of)