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Study aim
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determination of the effect of crocin on oxidative Stress biomarkers in patients under Angiography with Contrast Agents
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Design
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A randomized clinical trial with the control group, with parallel, randomized groups, phase 2 per 100 patients, rand function was used using Excel stratified random blocks method.
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Settings and conduct
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This study will be performed at Ayatollah Madani Hospital in Khorramabad, all patients in the intervention and control groups will receive 1ml/kg normal saline from 6 hours before to 6 hours after receiving Iodixanol. In addition to hydration, the intervention group will receive 30 mg crocin orally from the night before to the second night after angiography. The baseline level of the biomarkers (superoxide dismutase, malondialdehyde, catalase, glutathione peroxidase, reactive oxygen species), before the intervention, and to four hours after receiving contrast medium will be evaluated.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: patient consent; older than18 years old; systolic blood pressure of greater than 90 mm Hg Exclusion criteria: patient's tendency to exit from the study; the impossibility of intravenous hydration، participate in other clinical interventions over the past twenty-eight days; history of hypersensitivity to contrast media and saffron
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Intervention groups
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Control group: all patients will receive 1ml/kg normal saline from 6 hours before to 6 hours after receiving Iodixanol.
Intervention group: In addition to hydration, the intervention group will receive 30 mg crocin (Sami Saz Pharmaceutical Company) orally from the night before to the second night after angiography.
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Main outcome variables
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superoxide dismutase, malondialdehyde, catalase, glutathione peroxidase, reactive oxygen species, serum creatinine, and blood urea nitrogen