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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