Phase III randomized clinical trial of BV‐4051, an Ayurvedic polyherbal formulation in moderate SARS‐CoV‐2 infections and its impact on inflammatory biomarkers

Abstract

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.

Efficacy and Safety of Add-On Plant-Based Drugs for COVID-19 Patients: A Review of the Randomized Control Trials

“…Of the 163 articles identified, 12 studies were reckoned to meet the eligibility criteria and these articles were included for analysis (depicted in Figure 2). Out of 12 studies, 11 studies are conducted in COVID-19 patients [14][15][16][17][18][19][20][21][22][23][24] and 1 study is conducted in post-COVID-19 patients. 25 There are 22 varieties of plants involved as add-on therapy for COVID-19 patients.…”

Plant‐derived compounds as potential leads for new drug development targeting COVID‐19

“…It was discovered that glycyrrhizic acid nanoparticles inhibit murine coronavirus proliferation, reduce proinflammatory cytokine production and exert antiviral and anti‐inflammatory effects, alleviating organ injury and conferring a substantial survival advantage to infected mice (Zhao et al, 2021). BV‐4051, a combination of four Ayurvedic botanicals, was found to shorten illness duration and severity, prevent COVID‐19 complications and enhance immunity (Chitre et al, 2022). Ferulic acid and rutin in P. dioica extract were found to have anti‐inflammatory properties and to increase IL‐10 and mRNA21‐3p gene expression in HgCl2‐induced lung toxicity (El Gizawy et al, 2021).…”

Neglected Effective Early Therapies against COVID-19: Focus on Functional Foods and Related Active Substances. A Review

“…Moreover, Figure 2 shows all the curcumin RCTs in COVID-19, studying several other outcomes in addition to mortality (hospitalization, ventilation, numbers of recovery or recovery time, progression of the disease, oxigen saturation, viral positivity, in both early and late treatments): [17,[22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40]. This plot shows pooled effects, see the specific outcome analyses for individual outcomes, and the heterogeneity section [21] for discussion.…”

“…Figure 2. Random effects meta-analysis for all RCTs about curcumin in COVID-19[17,[22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40]. This plot shows pooled effects, see the specific outcome analyses for individual outcomes, and the heterogeneity section[21] for discussion.…”