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Study aim
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Effects of nano curcumin supplementation on the reduction of inflammation and mortality in patients with coronavirus 2019 admitted to ICU ward of Tabriz Imam Reza Hospital
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Design
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A randomized, controlled, double-blind, placebo-controlled clinical trial
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Settings and conduct
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Imam Reza Hospital, This study is a double-blind randomized clinical trial on two statistical populations, including patients with coronavirus in the ICU who receive four drugs oseltamivir, hydroxychloroquine, lopinavir, and ribavirin. Now, patients with the above conditions are divided into two groups receiving 240 mg daily oral nano curcumin and placebo recipients, both of which will have a treatment duration of 14 days. After sampling from both groups and isolating mononuclear cells (PBMC) from them, the expression levels of IL-1, IL-6, IL-17, and TNF-α genes were quantified using the Quantitative Real-Time PCR method. And after the intervention, it will be measured.
On the other hand, the ELISA technique is used to evaluate the levels of IL-1, IL-6, IL-17 and TNF-α secreting cytokines.
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Participants/Inclusion and exclusion criteria
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• In accordance with clinical diagnosis or etiologic criteria for coronavirus pneumonia (COVID-19).
• Willingness to cooperate
• Age range from 18 to 8 years
Not logged in:
• Nutrition and antioxidant supplements and alpha-lipoic acid during one month before the study
• Pregnancy and lactation
• Severe immune suppression (HIV infection, long-term use of immunosuppressive agents)
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Intervention groups
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The intervention group will receive 240 mg nano curcumin and the control group will receive placebo capsules daily. Patients will be given daily capsules in packs containing 60 capsules and we ask patients to take three capsules daily for 14 days.
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Main outcome variables
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Gene expression rate; cytokine secretion rate; clinical observations; laboratory observations