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0 0.5 1 1.5 2+ Discharge 37% Improvement Relative Risk Recovery, day 5 89% Recovery, day 7, dsypnea 80% Recovery, day 7, fever -3% Viral clearance, day 7 24% Viral clearance, day 5 5% Viral clearance, day 3 12% Antiandrogens  Bhardwaja et al.  EARLY TREATMENT  DB RCT Is early treatment with antiandrogens + multiple treatments beneficial for COVID-19? Double-blind RCT 76 patients in India (June - August 2021) Improved recovery (p=0.051) and viral clearance (p=0.47), not sig. Bhardwaja et al., Research Square, Dec 2021 Favors antiandrogen Favors control

An integrative approach to clinical recovery for COVID-19 patients using an Ayurvedic formulation: A multicentric double-blind randomized control trial

Bhardwaja et al., Research Square, doi:10.21203/, CTRI/2021/05/033790
Dec 2021  
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7th treatment shown to reduce risk in September 2020
*, now known with p = 0.000000056 from 49 studies.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,100+ studies for 60+ treatments.
Small RCT with 39 patients treated with NOQ19 and 37 placebo patients, showing improved recovery, without statistical significance. NOQ19 has multiple ingredients including curcumin, andrographis, and antiandrogen glycyrrhiza glabra.
This study is excluded in meta analysis: combined treatments may contribute more to the effect seen.
Study covers curcumin and andrographolide.
risk of no hospital discharge, 36.8% lower, RR 0.63, p = 0.67, treatment 2 of 39 (5.1%), control 3 of 37 (8.1%), NNT 34, day 7.
risk of no recovery, 89.1% lower, RR 0.11, p = 0.05, treatment 0 of 39 (0.0%), control 4 of 37 (10.8%), NNT 9.2, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), oxygen supplementation, day 5.
risk of no recovery, 80.4% lower, RR 0.20, p = 0.23, treatment 0 of 39 (0.0%), control 2 of 37 (5.4%), NNT 18, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 7, dsypnea.
risk of no recovery, 2.8% higher, RR 1.03, p = 1.00, treatment 13 of 39 (33.3%), control 12 of 37 (32.4%), day 7, fever.
risk of no viral clearance, 24.1% lower, RR 0.76, p = 0.47, treatment 12 of 39 (30.8%), control 15 of 37 (40.5%), NNT 10, day 7.
risk of no viral clearance, 5.1% lower, RR 0.95, p = 1.00, treatment 19 of 39 (48.7%), control 19 of 37 (51.4%), NNT 38, day 5.
risk of no viral clearance, 12.4% lower, RR 0.88, p = 0.47, treatment 24 of 39 (61.5%), control 26 of 37 (70.3%), NNT 11, day 3.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Bhardwaja et al., 27 Dec 2021, Double Blind Randomized Controlled Trial, India, preprint, 26 authors, study period 7 June, 2021 - 28 August, 2021, this trial uses multiple treatments in the treatment arm (combined with multiple treatments) - results of individual treatments may vary, trial CTRI/2021/05/033790.
This PaperAntiandrogensAll
An integrative approach to clinical recovery for COVID-19 patients using an Ayurvedic formulation: A multicentric double-blind randomized control trial.
Pankaj Bhardwaja, Kalaiselvan Ganapathy, Monika Pathania, K H Naveen, Jaykaran Charan, Siddhartha Dutta, Ravisekhar Gadepalli, Srikanth Sriniva, Manoj Kumar Gupta, Akhil D Goelj, Naresh Midha, Bharat Kumar, Meenakshi Sharma, Praveen Sharma, Mithu Banerjee, Prasenjit Mitra, Sanjeev Misra, Vinayagamoorthy V., Girija Subramaniant, Minakshi Dhar, Vartika Saxena, Puneet Dhamija, Archana Singh, Saumya Subramanian, Divya Kanchibhotlaz
Background Traditional medicine systems such as Ayurveda contain a vast repository of naturally occurring herbs with strong antimicrobial potency. A multitude of complementary therapies have been explored for their therapeutic role to treat COVID-19 during the pandemic. There have been promising results reported from in silico, in vitro and in vivo studies that need to be further explored in humans. Objective The present randomized placebo control trial evaluates the clinical e cacy of an integrated approach including Ayurvedic polyherbal formulation, NOQ19 in the improvement of mild to moderate category of COVID-19 infected patients. Patients and methods A multicentric, randomized, placebo control design was adopted for the study. A total of 76 patients with positive COVID-19 RT-PCR test were enrolled in the study; 39 in the NOQ19 arm and 37 in the placebo arm. Patients were randomized and blinded to their respective intervention, which was provided along with the standard of care treatment. Rate of recovery assessment was done on Day 3, 5 and 7 via RT-PCR test to measure the rate of recovery. Blood markers were analysed on Day 0 and Day 7. Outcomes The patients were assessed for rate of recovery via RT-PCR and improvement in blood biomarkers. They were also monitored for any adverse events or side effects of the drug. Results The present study demonstrated a signi cant early recovery in the patients who took the NOQ19 formulation. Patients who received NOQ19 with the standard care of treatment showed clinical improvement in terms of oxygen requirement, breathlessness and SpO2, though the difference was not statistically signi cant. Moreover, no side effects were observed with the use of NOQ19. Conclusion An overall integrated approach of standard of care treatment with Ayurvedic formulation (NOQ19) results in early clinical outcome in the management of mild to moderate cases of COVID-19.
Previous studies on the same formulation NOQ19 have shown promising results with respect to rate of recovery and antiviral e cacy [23] [24] [25] . A review of Ayurvedic literature presents robust preclinical evidence for e cacy of multiple NOQ19 ingredients such as Ashwagandha (Withania somnifera) and Guduchi (Tinospora cordifolia), along with Amalaki (Phyllanthus emblica) in proliferation of B and T cells and activation of nonspeci c immunity 32 . In addition, several other components of NOQ19 have been highlighted for their antiviral properties previously 8, 33, 34 . Yashtimadhu (Glycyrrhiza glabra) contains glycyrrhizin, a strong antiviral compound. In a previous study, treatment with different concentrations of glycyrrhizin lowered SARS-CoV viral antigen in a cell culture. At a concentration of 4000mg/ ml, Glycyrrhizin completely blocked the viral replication 35 . A key observation of our study was the improvement in oxygen levels and reduction in breathlessness among patients with COVID-19, when treated with NOQ19. An earlier study demonstrated the therapeutic e cacy of Vasaka (Adhatoda vasica), present in NOQ19, in an in vitro and in vivo model, via inhibiting the hypoxic response in both the models. A possible mechanism for this could be the reversal of mitochondrial dysfunction associated with hypoxic conditions like asthma, ARDS, etc. 36 . Presence of Vasaka (Adhatoda Vasica) in NOQ19 may be responsible for its antihypoxic effect on COVID-19 patients 37 ...
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