A triple-blind, placebo-controlled, randomized clinical trial to evaluate the effect of curcumin-containing nanomicelles on cellular immune responses subtypes and clinical outcome in COVID-19 patients
Hassaniazad et al.,
A triple-blind, placebo-controlled, randomized clinical trial to evaluate the effect of curcumin-containing..,
Phytotherapy Research, doi:10.1002/ptr.7294
Small RCT with 40 low risk patients in Iran, 20 treated with nano-curcumin, showing no significant difference in outcomes with treatment. Authors note that treatment can improve peripheral blood inflammatory indices and modulate immune response by decreasing Th1 and Th17 responses, increasing T regulatory responses, further reducing IL-17 and IFN-γ, and increasing suppressive cytokines TGF-β and IL-4.
relative improvement in SpO2, 45.7% worse, RR 1.46, p = 0.90, treatment 20, control 20.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Hassaniazad et al., 19 Sep 2021, Double Blind Randomized Controlled Trial, placebo-controlled, Iran, peer-reviewed, 12 authors.
Abstract: Received: 7 March 2021
Revised: 2 September 2021
Accepted: 4 September 2021
DOI: 10.1002/ptr.7294
RESEARCH ARTICLE
A triple-blind, placebo-controlled, randomized clinical trial to
evaluate the effect of curcumin-containing nanomicelles on
cellular immune responses subtypes and clinical outcome in
COVID-19 patients
Mehdi Hassaniazad1 | Ebrahim Eftekhar2 | Behnaz Rahnama Inchehsablagh3,4 |
Hossein Kamali3 | Abdolali Tousi3 | Mahmoud Reza Jaafari5,6,7 | Milad Rafat3 |
Mohammad Fathalipour8 | Sara Nikoofal-Sahlabadi9 |
Hesam Alizade1 | Amin Reza Nikpoor10
Hamed Gouklani1
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1
Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran
2
Endocrinology and Metabolism Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran
3
Student Research Committee, Faculty of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran
4
Department of Physiology, Faculty of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran
5
Nanotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran
6
Department of Pharmaceutical Nanotechnology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran
7
Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran
8
Department of Pharmacology and Toxicology, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran
9
Department of Pharmaceutics, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran
10
Molecular Medicine Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran
Correspondence
Amin Reza Nikpoor, Molecular Medicine
Research Center, Hormozgan Health Institute,
Hormozgan University of Medical Sciences,
Bandar Abbas, Iran.
Email: nikpoora@hums.ac.ir; nikpoora@
gmail.com
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 pla-
Funding information
The financial supports of Hormozgan
University of Medical Sciences, Bandar Abbas,
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.
cebo. 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 COVID19 can accelerate recovering of the acute..
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