Efficacy and safety of novel herbal tablets in COVID-19 patients in hospital stay days, ICU admission and mortality rate thereof: An open-label, single-blind randomized clinical trial

Abstract

Background: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the super-spreading virus, has claimed hundreds of thousands of lives worldwide. Objectives: This study aimed to evaluate the effectiveness of the novel suggested herbal compound, formulated as compressed tablets, in reducing the length of hospital stay (LoS), intensive care unit (ICU) admission, and mortality in confirmed COVID-19 cases. Methods: Following an open-label, single-blind randomized clinical trial design, a total of 200 patients aged 18-65 admitted to Imam Reza hospital in Tabriz, northwest of Iran, were randomized to intervention and control groups in a 1:1 ratio, i.e., 100 subjects in each group. The former received standard treatment along with the compressed herbal tablets, and the latter only received the standard treatment. Adverse reactions incidence within 180 days after the beginning of the intervention was set as the primary safety endpoint. The most important and active ingredients of the tablets were Terminalia chebula, Glycyrrhiza glabra, Anacyclus pyrethrum, Senna alexandrina, Ferrula asafoetida, Pistacia lentiscus, Zizyphus jujuba, Crocus sativus, Echinacea angustifolia, and Hyssopus officinalis. This trial is registered at the Iranian Registry of Clinical Trials (code: IRCT20200522047545N1). Results: Those in the intervention arm had significantly lower rates of LoS (7.38 vs. 9.45, P = 0.030), ICU admission (6 out of 100 vs. 32 out of 100, P = 0.000), and mortality (1 vs. 19 out of 100, P = 0.000). Conclusions: Our observations suggest that adequate improvement is provided by the prepared herbal compound along with substantial savings in hospitalization hoteling costs. While further multi-center studies with a larger sample size are needed to extend our knowledge regarding the effect of this new option, these novel clinical data may well provide a new alternative for the management of COVID-19 disease.