The effects of saffron supplementation on inflammatory factors and clinical outcomes in sepsis patients admitted to the intensive care unit (ICU): Study protocol for a double-blind randomized controlled clinical trial | ||
| Avicenna Journal of Phytomedicine | ||
| دوره 15، شماره 3، مرداد و شهریور 2025، صفحه 1137-1146 اصل مقاله (728.2 K) | ||
| نوع مقاله: Original Research Article | ||
| شناسه دیجیتال (DOI): 10.22038/ajp.2024.25221 | ||
| نویسندگان | ||
| Shirin Hassanizadeh1؛ Babak Alikiaii2؛ Mohammad Hossein Rouhani3؛ Zeinab Mokhtari3؛ Mohammadreza Moznebiisfahani4؛ Manoj Sharma5؛ Mohammad Bagherniya* 6 | ||
| 1Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran. | ||
| 2Associate Professor of Critical Care Medicine, Department of Anesthesiology, Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. | ||
| 3Department of Community Nutrition, School of Nutrition and Food Science, Nutrition and Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. | ||
| 4Department of Neurosurgery, Isfahan University of Medical Sciences, Isfahan, Iran. | ||
| 5Environmental & Occupational Health, School of Public Health, University of Nevada, Las Vegas, NV, USA | ||
| 6Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran. Anesthesia and Critical | ||
| چکیده | ||
| Objective: Research studies have examined saffron's effects on inflammation, infection, and oxidative stress. Nevertheless, the effects of saffron on sepsis patients in the intensive care units (ICUs) have not yet been studied. Hence, this study will examine the effects of saffron supplementation on oxidative stress biomarkers, inflammation factors, and clinical outcomes in critically ill septic patients. Materials and Methods: Ninety patients with sepsis will participate in this parallel double-blind, randomized clinical controlled trial. In addition to usual care, the intervention group (n=45) will receive a daily tablet containing 100 mg/day saffron for 7 days, and the control group (n=45) will receive a placebo tablet containing 100 mg/day corn starch for the same duration. Acute Physiology and Chronic Health Evaluation II (APACHE II), the Sequential Organ Failure Assessment (SOFA), and the NUTRIC Score will be used to assess the patients' clinical and nutritional status at the beginning and end of the study. Inflammatory markers including erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), interleukin (IL)-6, tumor necrosis factor-alpha (TNF-α), and IL-18, indicators of oxidative stress including malondialdehyde (MDA), glutathione peroxidase (GPx), catalase, superoxide dismutases (SODs), and total antioxidant capacity (TAC), level of Glasgow Coma Scale (GCS), complete blood count (CBC), and lactate dehydrogenase (LDH) will be evaluated at beginning and end of the study. Twenty-eight days after the start of the intervention mortality rates will be assessed. Discussion: Due to the anti-inflammatory, antioxidant, and antimicrobial effects, saffron might have beneficial effects in critically ill patients with sepsis. | ||
| کلیدواژهها | ||
| Critically ill؛ ICU؛ Inflammation؛ Saffron؛ Oxidative stress؛ Sepsis | ||
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