A triple‐blind, placebo‐controlled, randomized clinical trial to evaluate the effect of curcumin‐containing nanomicelles on cellular immune responses subtypes and clinical outcome inCOVID‐19 patients

Abstract

Iran (grant no. 990126) is acknowledged. The Exir Nano Sina company had no role in funding or dedication of SinaCurcumin and placebo capsules, data collection, analysis, and interpretation of data.In COVID-19 patients, cytokine storm due to excessive immune responses can cause severe complications. In this study, we investigated the effect of curcumin nanomicelles on clinical outcome and cellular immune responses subtypes changes in COVID-19 patients. A randomized, triple-blinded, placebo-controlled study was done.Forty COVID-19 patients were included into two groups of nano-curcumin and placebo. The nano-curcumin group received 40 mg of nano-curcumin capsule, four times per day for 2 weeks. Clinical signs and gene expression of TBX21, GATA3, RORC and FOXP3 genes and IFN-γ, IL-4, IL-17 and TGF-β cytokines serum levels were measured at time points of 0, 7 and 14 days. Serum levels of IFN-γ (p = .52) and IL-17 (p = .11) decreased, while IL-4 (p = .12) and TGF-β (p = .14) increased in the nanocurcumin group compared with placebo on day 14. Moreover, gene expressions of TBX21 (p = .02) and FOXP3 (p = .005) genes were significantly decreased and increased between nano-curcumin and placebo groups on day 7, respectively. It can be concluded that administration of nano-curcumin in inflammatory phase of COVID-19 can accelerate recovering of the acute inflammatory phase by modulating inflammatory immune responses. Therefore, it is suggested that this supplement in inflammatory diseases, including COVID-19, can be effective in controlling the inflammatory responses.

The effects of curcumin as dietary supplement for patients with COVID-19: A systematic review of randomized clinical trials

“…Nine studies were excluded; five had wrong study designs (16)(17)(18)(19)(20), one had a wrong population (21), and three were protocols. As a result, six RCTs met our inclusion criteria for the systematic review (12,13,(22)(23)(24)(25) (Figure 1).…”

“…RCTs evaluating the effect of curcumin on patients with COVID-19 were included in this systematic review. Two RCTs were triple blinded (22,23), and four were double-blinded (12,13,24,25). One RCT was done in India (24), and the rest in Iran (12,13,22,23,25).…”

“…Two RCTs were triple blinded (22,23), and four were double-blinded (12,13,24,25). One RCT was done in India (24), and the rest in Iran (12,13,22,23,25). The RCTs included in our systematic review differ in the type and dose of Curcumin dosage, which ranged from 80 mg to 160 mg for 2-3 weeks in five RCTs (12,13,22,23,25), and 950 mg for two weeks in the last RCT (24).…”

“…All RCTs evaluated the effects of curcumin on the lymphocyte count, reporting that lymphocyte count was significantly higher in the curcumin group than in the placebo group (12,13,(22)(23)(24)(25).…”

“…Four RCTs reported outcomes evaluating the effect of curcumin on gene expression of transcription factors and cytokines (12,13,23,25). Tahmasebi, El-Esawi et al…”