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IRCT20110123005670N7 IRCT 2017-12-15 Tabriz University of Medical Sciences The Effect of curcumin on patients with systemic inflammatory response syndrome coiss The Effect of curcumin on oxidative indices, inflammatory factors and Sequential Organ Failure Assessment Score in patients with systemic inflammatory response syndrome 2017-12-22 anticipated 40 Complete https://irct.ir/trial/27753 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: -, Randomization description: With Using of RAS software in two groups of 20 people. 3 Sepsis/At risk of sepsis. Intervention 1: Intervention group: Two curcumin capsules(Sina Pharmaceutical Company) of 80 mg per day for ten days. Intervention 2: Control group: Common formulas. https://www.sciencedirect.com/science/article/abs/pii/S1876382019309886 Introduction Sepsis is a severe reaction and excessive immune response to infection, which can lead to tissue damage, organ dysfunction, and death. This study aimed to investigate the protective effect of curcumin on inflammatory factors and clinical outcomes in patients with sepsis. Methods This randomized clinical trial was conducted on 40 patients with sepsis aged 18–55 years, who received 160 mg of nano curcumin supplement (two capsules 80 mg) or placebo (two capsules of placebo) via a nasogastric tube for 10 days. Sequential organ failure assessment (SOFA) was evaluated on days 1 and 10. Serum levels of inflammatory factors of procalcitonin (PCT), Interleukin- 6 (IL-6), tumor necrosis factor-alpha, (TNF-α),and high-sensitive C-reactive protein (hs-CRP) were measured before the beginning of the intervention and on days 5 and 10. Length of hospital stay, mortality rate, and mechanical ventilation duration was compared between groups. Results Serum levels of PCT (p = 0.002), IL-6 (p = 0.012), and TNF-α (p = 0.026) in the nano curcumin group on day 10 were significantly lower than in the placebo group. The duration of mechanical ventilation in the nano curcumin group was remarkably (p = 0.038) lower than in the placebo group. Also, the SOFA score significantly (p = 0.005) decreased in the intervention group compared to the placebo group. No significant difference was observed in the mean serum levels of hs-CRP, duration of the intensive care unit stay, and mortality rates between the study groups. Conclusions Our study indicated that nano curcumin could decrease the levels of inflammatory factors, duration of mechanical ventilation, and organ failure in critically ill patients. 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 Some data has not been printed yet
public Dr.Ali Tarighat-Esfanjani
Nutrition Faculty, Attarneyshabouri street, Golgasht street
TABRIZ Iran (Islamic Republic of) 5166614711 +98 41 3335 2292 tarighata@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Ali Tarighat esfanjani
Nutrition Faculty, Attarneyshabouri street, Golgasht street
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 2292 tarighata@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Critically ill ICU patients with APACHE II score of 15-30; Positive SIRS; Aged over 18 and under the age of 60 years; Hospitalization at least 10 days in ICU; Recipients of enteral nutrition formula 18 years 60 years Both Parenteral feeding; Intolerance to enteral feeding and gavage solution; Patient is waiting for death in the 24 future hourse; HIV positive patient; pregnant and lactating women; Ileus; Mellitus diabetes; Short bowel syndrome; Pancreatitis; Immune disorders R65.1 Systemic inflammatory response syndrome (SIRS) of non-infectious origin Treatment - Drugs N/A Intervention group: Two curcumin capsules(Sina Pharmaceutical Company) of 80 mg per day for ten days Control group: Common formulas Inflammation. Timepoint: First, fifth, and tenth day. Method of measurement: Interleukin 6 and tumor necrosis factor-alpha, Forkhead box P3, NLR family pyrin domain containing 3, interferon-gamma, and nuclear factor kappa B, high mobility group box 1, Interleukin 8 ,Interleukin 17 and Interleukin 22, Interleukin 10, presepsin, TLR4, ICAM- 1, VCAM-1and PCT. Oxidative stress. Timepoint: First, fifth, and tenth day. Method of measurement: Total antioxidant capacity and malondialdehyde, Nrf2,SOD, GPX, BAX, BCL2. Sequential Organ Failure Assessment (SOFA). Timepoint: First, fifth, and tenth day. Method of measurement: Questionnaire. Nutrition status. Timepoint: روز1، 5و روز 10. Method of measurement: Received calorie measuring. Biochemical factors. Timepoint: روز1، 5و روز 10. Method of measurement: Biochemistry kit. Vice-Dean for Research and Technology Tabriz University Of Medical Science Approved 2017-11-13 Ethics Committee of Tabriz University of Medical Sciences Golghast Street Tabriz East Azarbaijan Iran (Islamic Republic of)