Abstract: Revised: 17 October 2022 Accepted: 25 October 2022 DOI: 10.1002/ptr.7683 RESEARCH ARTICLE Phase III randomized clinical trial of BV-4051, an Ayurvedic polyherbal formulation in moderate SARS-CoV-2 infections and its impact on inflammatory biomarkers Deepa Chitre 1 | Satej Nadkarni 1 Amol Gitte 4 | Prashant Rahate 5 1 Bioved Pharmaceuticals, Inc., San Jose, California, USA | | Namdev Jagtap 2 Sunetra Chaskar 6 | Rahul Tulle 3 | | Debendranath Dey 1 Abstract 2 Vishwaraj Hospital, Loni Kalbhor, Pune, India SARS-CoV-2 virus and its variants continue to be a challenge inspite of widespread 3 Vedant Hospital, Thane, Mumbai, India vaccination and preventive measures. We hypothesized an oral, safe polyherbal for- 4 Siddhivinayak Hospital, Thane, Mumbai, India 5 Seven Star Hospital, Nagpur, India 6 Bioved Pharmaceuticals Pvt. Ltd., Pune, India mulation with antiinflammatory properties may improve the clinical outcome of this disease. BV-4051, a formulation from four Ayurvedic plants namely Ashwagandha, Boswellia, Ginger and Turmeric was used for the treatment of hospitalized moderate Correspondence Deepa Chitre, Bioved Pharmaceuticals, Inc., 1929 O'Toole Way, San Jose, CA 95131, USA. Email: dchitre@bioved.com COVID-19 patients along with standard of care (SOC). Patients were randomly assigned to receive BV-4051 or placebo tablets for 14 days, at four sites in India during late 2020 to early 2021. Among 208 randomized subjects, 175 completed the study. In BV-4051 group the mean reduction in duration of illness (p = 0.036), alleviation and severity scores of several symptoms like fever, cough, smell, and taste disorders were statistically significant (p ≤ 0.05). A sub-set analysis of subjects treated with or without Remdesivir as SOC showed mean reduction in duration of illness in BV-4051 (p = 0.030), and severity scores (p ≤ 0.05). Mean difference in Interleukin-6 was statistically significant (p = 0.042) on BV-4051 without Remdesivir. BV-4051 may reduce duration of illness, symptoms severity, Interleukin-6, and prevent the incidence of COVID-19 complications. It may have an adjunctive effect with other SOC. Larger extensive clinical testing may give a better understanding of its effect. KEYWORDS ARTOVID-20®, Ayurveda, Covid-19, herbal, interleukin-6, Remdesivir 1 | I N T RO DU CT I O N certain populations in developed nations, the disease and its variants continue to cause significant morbidity, mortality, and economic Aggressive global vaccination efforts, widespread public healthcare impact (World Bank Report, 2022). measures, and a better understanding of treatment modalities provide Immune hyperactivation in COVID-19 is precipitated by a surge a significant improvement in the management of the SARS-CoV2 pan- of critical immune mediators including Tumor Necrosis Factor (TNF), demic. However, in many developing countries and also among Interferon-Gamma (IFN-γ), and Interleukin-6 (IL-6) that leads to respiratory failure, shock, and multi-organ dysfunction (Ablamunits & Clinical Trials Registry of India: CTRI/2020/09/027817. Lepsy, 2022; Herold et al., 2020; Mandel et al., 2020). There have This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. © 2022 Bioved Pharmaceuticals, Inc. Phytotherapy Research published by John Wiley & Sons Ltd. Phytotherapy Research...