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0 0.5 1 1.5 2+ Recovery time 11% Improvement Relative Risk Fever 11% Congestion 20% Sore throat 20% Cough 14% Dyspnea 15% Pain 8% Fatigue 17% Headache 17% Chills 18% Diarrhea 25% Vomiting 18% Smell 17% Taste 17% Curcumin  Chitre et al.  EARLY TREATMENT  DB RCT Is early treatment with curcumin + combined treatments beneficial for COVID-19? Double-blind RCT 175 patients in India (September 2020 - April 2021) Faster recovery with curcumin + combined treatments (p=0.036) Chitre et al., Phytotherapy Research, Nov 2022 Favors curcumin Favors control

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

Chitre et al., Phytotherapy Research, doi:10.1002/ptr.7683, CTRI/2020/09/027817
Nov 2022  
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RCT 208 moderate COVID-19 patients in India, 103 treated with a combination of turmeric, ashwagandha, boswellia, and ginger, showing improved recovery with treatment. The dose of curcumin is unknown and bioavailability may be poor.
This is the 16th of 20 COVID-19 RCTs for curcumin, which collectively show efficacy with p=0.0000093.
This is the 22nd of 26 COVID-19 controlled studies for curcumin, which collectively show efficacy with p=0.000000046 (1 in 22 million).
recovery time, 11.3% lower, relative time 0.89, p = 0.04, treatment 89, control 86.
fever, 11.0% lower, RR 0.89, p = 0.03, treatment 70 of 89 (78.7%), control 76 of 86 (88.4%), NNT 10, day 4.
congestion, 20.0% lower, RR 0.80, p = 0.05, treatment 89, control 86, mid-recovery, day 7.
sore throat, 20.0% lower, RR 0.80, p = 0.09, treatment 89, control 86, mid-recovery, day 7.
cough, 14.3% lower, RR 0.86, p = 0.14, treatment 89, control 86, mid-recovery, day 7.
dyspnea, 15.4% lower, RR 0.85, p = 0.15, treatment 89, control 86, mid-recovery, day 7.
pain, 8.3% lower, RR 0.92, p = 0.41, treatment 89, control 86, mid-recovery, day 7.
fatigue, 16.7% lower, RR 0.83, p = 0.13, treatment 89, control 86, mid-recovery, day 7.
headache, 16.7% lower, RR 0.83, p = 0.12, treatment 89, control 86, mid-recovery, day 7.
chills, 18.2% lower, RR 0.82, p = 0.09, treatment 89, control 86, mid-recovery, day 7.
diarrhea, 25.0% lower, RR 0.75, p = 0.08, treatment 89, control 86, mid-recovery, day 7.
vomiting, 18.2% lower, RR 0.82, p = 0.07, treatment 89, control 86, mid-recovery, day 7.
smell, 16.7% lower, RR 0.83, p = 0.06, treatment 89, control 86, mid-recovery, day 7.
taste, 16.7% lower, RR 0.83, p = 0.14, treatment 89, control 86, mid-recovery, day 7.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Chitre et al., 23 Nov 2022, Double Blind Randomized Controlled Trial, placebo-controlled, India, peer-reviewed, 8 authors, study period September 2020 - April 2021, this trial uses multiple treatments in the treatment arm (combined with ashwagandha, boswellia, ginger) - results of individual treatments may vary, trial CTRI/2020/09/027817.
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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 with a copy to 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.
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