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Effectiveness of ayurvedic formulation, NAOQ19 along with standard care in the treatment of mild-moderate COVID-19 patients: A double blind, randomized, placebo-controlled, multicentric trial

Bhardwaj et al., Journal of Ayurveda and Integrative Medicine, doi:10.1016/j.jaim.2023.100778, CTRI/2021/05/033790
Nov 2023  
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Hospitalization time 13% Improvement Relative Risk Recovery, dsypnea 80% Recovery, fever -400% Recovery, cough 0% Recovery, headache 45% Recovery, sore throat 0% Time to viral- 12% Viral clearance, day 7 58% Viral clearance, day 5 27% Viral clearance, day 3 27% Andrographolide  Bhardwaj et al.  EARLY TREATMENT  DB RCT Is early treatment with andrographolide + multiple treatments beneficial for COVID-19? Double-blind RCT 150 patients in India (June - August 2021) Shorter hospitalization (p=0.046) and faster viral clearance (p=0.018) c19early.org Bhardwaj et al., J. Ayurveda and Integ.., Nov 2023 Favorsandrographolide Favorscontrol 0 0.5 1 1.5 2+
RCT 150 mild-moderate COVID-19 patients showing faster viral clearance and shorter hospitalization with NAOQ19, a polyherbal formulation containing 13 antiviral/antinflammatory compounds. NAOQ19 ingredients include curcumin, andrographis, and antiandrogen glycyrrhiza glabra.
This study is excluded in meta analysis: combined treatments may contribute more to the effect seen.
Study covers andrographolide and curcumin.
hospitalization time, 12.8% lower, relative time 0.87, p = 0.046, treatment 75, control 75.
risk of no recovery, 80.0% lower, RR 0.20, p = 0.50, treatment 0 of 75 (0.0%), control 2 of 75 (2.7%), NNT 38, 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, 400.0% higher, RR 5.00, p = 0.50, treatment 2 of 75 (2.7%), control 0 of 75 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm), day 7, fever.
risk of no recovery, no change, RR 1.00, p = 1.00, treatment 4 of 75 (5.3%), control 4 of 75 (5.3%), day 7, cough.
risk of no recovery, 45.5% lower, RR 0.55, p = 0.30, treatment 6 of 75 (8.0%), control 11 of 75 (14.7%), NNT 15, day 7, headache.
risk of no recovery, no change, RR 1.00, p = 1.00, treatment 3 of 75 (4.0%), control 3 of 75 (4.0%), day 7, sore throat.
time to viral-, 11.5% lower, relative time 0.88, p = 0.02, treatment 75, control 75.
risk of no viral clearance, 57.9% lower, RR 0.42, p = 0.03, treatment 8 of 75 (10.7%), control 19 of 75 (25.3%), NNT 6.8, day 7.
risk of no viral clearance, 27.3% lower, RR 0.73, p = 0.18, treatment 24 of 75 (32.0%), control 33 of 75 (44.0%), NNT 8.3, day 5.
risk of no viral clearance, 27.1% lower, RR 0.73, p = 0.048, treatment 35 of 75 (46.7%), control 48 of 75 (64.0%), NNT 5.8, day 3.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Bhardwaj et al., 15 Nov 2023, Double Blind Randomized Controlled Trial, placebo-controlled, India, peer-reviewed, 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. Contact: director.ssiar@artofliving.org.
This PaperAndrographol..All
Effectiveness of ayurvedic formulation, NAOQ19 along with standard care in the treatment of mild-moderate COVID-19 patients: A double blind, randomized, placebo-controlled, multicentric trial
Pankaj Bhardwaj, Kalaiselvan Ganapathy, Monika Pathania, K H Naveen, Jaykaran Charan, Siddhartha Dutta, Ravisekhar Gadepalli, Srikanth Srinivasan, Manoj Kumar Gupta, Akhil D Goel, Naresh Midha, Bharat Kumar, Meenakshi Sharma, Praveen Sharma, Mithu Banerjee, Prasenjit Mitra, Sanjeev Misra, Vinayagamoorthy V b Girija Subramaniant, Praveen R k Minakshi Dhar, Vartika Saxena, Puneet Dhamija, Archana Singh, Saumya Subramanian, Divya Kanchibhotla
Journal of Ayurveda and Integrative Medicine, doi:10.1016/j.jaim.2023.100778
Background: Medicines in indigenous systems such as Ayurveda have strong antimicrobial activity but doubleblind randomized control trials are infrequent in this system of medicine. The efficacy of a new ayurvedic formulation was evaluated during the pandemic. Methods: 150 mild-moderate COVID-19 patients were enrolled and randomized in 1:1 to NAOQ19 and placebo group. RT-PCR was done on Day 3, 5 and 7. CBC, CRP, LFT, and KFT were assessed at baseline and exit. Duration of hospital stay was noted and clinical assessment was also performed. Result: The results demonstrated more people turning RT-PCR negative in the NAOQ19 group compared to the placebo group on day 3 (p-value = 0.033). The mean time duration to turn RT-PCR negative was significantly lower in the NAOQ19 group (4.6 days) compared to placebo group (5.2 days) (p-value = 0.018). There was significant reduction in hospital stay among patients in the NAOQ19 arm who were discharged earlier (5.6 days) compared to placebo group (6.4 days) (p-value = 0.046). Patients in NAOQ19 arm did not show any adverse lifethreatening events. Conclusion: The ayurvedic preparation given along with standard of care therapy reduced the duration of hospital stay and there was earlier conversion to RT-PCR negative.The integrated approach can help to reduce patient workload in the hospitals as well as limit the transmission of the virus in the community.
Author contributions Conceptualization: Divya Kanchibhotla, Pankaj Bhardwaj; Data curation: Pankaj Bhardwaj, Kalaiselvan Ganapathy, Monika Pathania, K H Naveen, Jaykaran Charan, Siddhartha Dutta, Ravisekhar Gadepalli, Srikanth Srinivasan, Manoj Kumar Gupta, Akhil D Goel, Naresh Midha, Bharat Kumar, Meenakshi Sharma, Praveen Sharma, Mithu Banerjee, Prasenjit Mitra, Sanjeev Misra, Vinayagamoorthy V, Girija Subramaniant, Praveen R Puneet Dhamija, Archana Singh; Formal Analysis: Divya Kanchibhotla, Saumya Subramanian; Declaration of competing interest Besides providing the NAOQ19 intervention tablets, Sriveda Sattva Pvt. Ltd. was not involved in any aspect of this study. All the other authors have no conflicts of interest to declare. Ethical approval The study was approved by Institutional Ethics Committee with registration number as follows: AIIMS Jodhpur AIIMS/IEC/2021/3626; AIIMS Rishikesh AIIMS/IEC/21/306 and SMVMCH, Puducherry SMVMCH-ECO-AL/153/2021. The study was registered at Clinical Trial Registry, India bearing registration number CTRI/2021/05/033790.
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evaluation in major organ cell representatives', 'volume': '84', 'author': 'Sa-Ngiamsuntorn', 'year': '2021', 'journal-title': 'J Nat Prod'}, { 'issue': '1', 'key': '10.1016/j.jaim.2023.100778_bib20', 'doi-asserted-by': 'crossref', 'DOI': '10.1080/09537104.2023.2184183', 'article-title': 'Immature platelets in COVID-19', 'volume': '34', 'author': 'Wolny', 'year': '2023', 'journal-title': 'Platelets'}, { 'issue': '4', 'key': '10.1016/j.jaim.2023.100778_bib21', 'doi-asserted-by': 'crossref', 'first-page': '629', 'DOI': '10.1002/pca.3011', 'article-title': 'Immunoprotective potential of Ayurvedic herb Kalmegh (Andrographis ' 'paniculata) against respiratory viral infections–LC–MS/MS and network ' 'pharmacology analysis', 'volume': '32', 'author': 'Banerjee', 'year': '2021', 'journal-title': 'Phytochem Anal'}, { 'issue': '11', 'key': '10.1016/j.jaim.2023.100778_bib22', 'doi-asserted-by': 'crossref', 'first-page': '2911', 'DOI': '10.1002/ptr.6738', 'article-title': 'Potential effects of 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evaluate efficacy ' 'of Ayurveda interventions in the management of asymptomatic and mild ' 'COVID-19 patients-experiences of a Lucknow based level 2 hospital of ' 'Uttar Pradesh, India', 'volume': '13', 'author': 'Rais', 'year': '2022', 'journal-title': 'J Ayurveda Integr Med'}, { 'key': '10.1016/j.jaim.2023.100778_bib26', 'doi-asserted-by': 'crossref', 'DOI': '10.1016/j.phymed.2021.153494', 'article-title': 'Randomized placebo-controlled pilot clinical trial on the efficacy of ' 'ayurvedic treatment regime on COVID-19 positive patients', 'volume': '84', 'author': 'Devpura', 'year': '2021', 'journal-title': 'Phytomedicine'}, { 'issue': '3', 'key': '10.1016/j.jaim.2023.100778_bib27', 'doi-asserted-by': 'crossref', 'DOI': '10.1016/j.jaim.2022.100581', 'article-title': 'An In-vitro evaluation of a polyherbal formulation, against SARS-CoV-2', 'volume': '13', 'author': 'Kanchibhotla', 'year': '2022', 'journal-title': 'J Ayurveda Integr Med'}, { 'key': '10.1016/j.jaim.2023.100778_bib28', 'first-page': '5', 'article-title': 'The efficacy of a plant based formulation in the symptomatic management ' 'of mild COVID-19 cases: a double blind, randomized controlled trial', 'volume': '7', 'author': 'Kumar Das', 'year': '2023', 'journal-title': 'AMCRS'}, { 'issue': '4', 'key': '10.1016/j.jaim.2023.100778_bib29', 'first-page': '134', 'article-title': 'Rate of recovery and symptomatic efficacy of a polyherbal AYUSH ' 'formulation in the treatment of SARS-CoV-2 disease: a single-arm trial', 'volume': '29', 'author': 'Kanchibhotla', 'year': '2023', 'journal-title': 'Alternative Ther Health Med'}, { 'key': '10.1016/j.jaim.2023.100778_bib32', 'doi-asserted-by': 'crossref', 'DOI': '10.1016/j.conctc.2021.100755', 'article-title': 'A randomized and comparative study to assess safety and efficacy of ' 'supplemental treatment of a herbal formulation-Aayudh Advance ' 'comprising essential oils in patients with corona virus 2019 (COVID-19)', 'volume': '22', 'author': 'Dutt', 'year': '2021', 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