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, Satej Nadkarni, Namdev Jagtap, Rahul Tulle, Amol Gitte, Prashant Rahate, Sunetra Chaskar, Debendranath Dey
Phytotherapy Research, doi:10.1002/ptr.7683
SARS-CoV-2 virus and its variants continue to be a challenge inspite of widespread vaccination and preventive measures. We hypothesized an oral, safe polyherbal formulation 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 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.
CONFLICT OF INTEREST Deepa Chitre, MD has shares in Bioved Pharmaceuticals, Inc.; Satej Nadkarni, PhD and Debendranath Dey, PhD have stock options in Bioved Pharmaceuticals, Inc.
DATA AVAILABILITY STATEMENT All of the individual participant data collected during the trial, Study Protocol, Statistical Analytical Plan, Informed Consent Form and Clinical Study Report shall be available immediately after publication, for a period of 5 years. Researchers who provide an interest and methodologically sound proposal should contact dchitre@bioved.com with a copy to snadkarni@bioved.com. To gain access, researchers will need to sign a data access agreement. Placeholder Text
ORCID
SUPPORTING INFORMATION Additional supporting information can be found online in the Supporting Information section at the end of this article. How to cite this article: Chitre, D., Nadkarni, S., Jagtap, N., Tulle, R., Gitte, A., Rahate, P., Chaskar, S., & Dey, D. (2022) . Phase III randomized clinical trial of BV-4051, an Ayurvedic polyherbal formulation in moderate SARS-CoV-2 infections and its impact on inflammatory biomarkers. Phytotherapy Research, 1-10. https://doi.org/10.1002/ptr.7683
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