Evaluation of the efficacy of oral nano‐silymarin formulation in hospitalized patients with COVID‐19: A double‐blind placebo‐controlled clinical trial
Hossein Aryan, Ramin Hamidi Farahani, Mohsen Chamanara, Sepideh Elyasi, Mahmoud Reza Jaafari, Mahboubeh Haddad, Ashraf Tavanaee Sani, Mohamed Afshar Ardalan, Reza Mosaed
Phytotherapy Research, doi:10.1002/ptr.7537
Considering the outbreak pandemic of Coronavirus Disease 2019 (COVID-19), the lack of effective therapeutic strategies for the management of this viral disease, and the increasing evidence on the antiviral potential of silymarin, this study aimed to investigate the effectiveness of silymarin nanomicelles on the symptom's resolution time, laboratory parameters, and liver enzymes in patients with COVID-19. The participants were assigned to the nano-silymarin (n = 25) (receiving SinaLive soft gel, containing 70 mg silymarin as nanomicelles) or placebo groups (n = 25) three times daily for two weeks. Patients' symptoms and laboratory findings were assessed at baseline and during the follow-up period (one week and one month after the beginning of the treatment). No significant differences were observed between the two groups in terms of symptoms resolution time, laboratory parameters, and hospitalization duration (p > 0.05). However, the alanine aminotransferase level decreased significantly in the treatment group, compared to the placebo group (p < 0.001). Concomitant use of dexamethasone and remdesivir with silymarin might make the effects of silymarin on the improvement of patients' condition unclear. Further clinical trials are recommended with diverse dosages and larger sample sizes.
CONFLICT OF INTEREST Dr. Mahmoud Reza Jaafari, one of the manuscript authors, is the founder of Exir Nano Sina Company which produced the studied medication. Other authors have nothing to declare.
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"abstract": "<jats:title>Abstract</jats:title><jats:p>Considering the outbreak pandemic of Coronavirus Disease 2019 (COVID‐19), the lack of effective therapeutic strategies for the management of this viral disease, and the increasing evidence on the antiviral potential of silymarin, this study aimed to investigate the effectiveness of silymarin nanomicelles on the symptom's resolution time, laboratory parameters, and liver enzymes in patients with COVID‐19. The participants were assigned to the nano‐silymarin (<jats:italic>n</jats:italic> = 25) (receiving SinaLive soft gel, containing 70 mg silymarin as nanomicelles) or placebo groups (<jats:italic>n</jats:italic> = 25) three times daily for two weeks. Patients' symptoms and laboratory findings were assessed at baseline and during the follow‐up period (one week and one month after the beginning of the treatment). No significant differences were observed between the two groups in terms of symptoms resolution time, laboratory parameters, and hospitalization duration (<jats:italic>p</jats:italic> > 0.05). However, the alanine aminotransferase level decreased significantly in the treatment group, compared to the placebo group (<jats:italic>p</jats:italic> < 0.001). Concomitant use of dexamethasone and remdesivir with silymarin might make the effects of silymarin on the improvement of patients' condition unclear. Further clinical trials are recommended with diverse dosages and larger sample sizes.</jats:p>",
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