AYUSH 64, a polyherbal Ayurvedic formulation in Influenza-like illness - Results of a pilot study

Influenza like illness related clinical trial on AYUSH-64 requires cautious interpretation

“…In order to achieve this feat, iterations and rectification based on a meticulous evaluation of the methods, data and their limitations becomes absolutely necessary. Accordingly, we suggest the team of authors associated with the publication under discussion [ 4 ] should re-examine their interpretations in light of the flaws identified here. Otherwise, it may add to the ongoing parallel global epidemic of unsubstantiated, misinterpreted and equivocal research.…”

“…We read with deep interest, the pilot study reported by Gundeti and colleagues aiming to evaluate the safety and efficacy of Ayurvedic formulation AYUSH-64 in clinically diagnosed patients suffering from Influenza-like illness (ILI). While the community is awaiting results of AYUSH related clinical trials for COVID-19 treatment, this study [ 4 ] came as a pioneering formal step towards a potential repurposing of AYUSH-64 against COVID-19. However, on careful analyses, we find that the interpretations arrived at in this study need caution because of limitations in the design of clinical trial and analysis of the results.…”

“…Furthermore, the comparator agent is noted as nil. However, when the trial was conducted, modern medicines viz., “acetaminophen, antihistaminic and cough syrup as per the standard guidelines” were co-prescribed [ 4 ]. This co-intervention of modern medicine constitutes a critical departure from the recorded intervention at CTRI database.…”

“…It is to be noted that while Gundeti et al. [ 4 ] reiterate the limitation of their study to be aimed at “ only clinical safety related biochemical parameters ”, they go ahead to conclude that “ AYUSH-64 along-with standard care in ILI is safe and efficacious and it may be used in other viral infections with pyrexia as add-on to standard care for early recovery and better outcome ”. Here, when the ‘conclusion’ is read along with ‘limitations’, a self-evident contradiction emerges that authors need to address.…”

“…Therefore, scientific community now conducting research on AYUSH-64 should exercise extra caution in light of the previous uneasy experiences with this drug. It may be recalled that AYUSH-64 had failed the phase 2 clinical trial against malaria [ 4 ], and could never form part of malaria strategy of India. Additionally, it is vital to remember that the kind of unsubstantiated claims made during its initial launch were also criticized by the scientific fraternity [ 2 ].…”