AYUSH-64, a drug developed for curing malaria in 1980, can be useful for the treatment of asymptomatic, mild and moderate COVID-19 infection cases, the Ministry of AYUSH said on Thursday.
Addressing a virtual press conference, Arvind Chopra, director of Centre for Rheumatic Diseases, Pune, said the trial of the drug in this direction was conducted at three centers.
The trial at King George's Medical University (KGMU), Lucknow; Datta Meghe Institute of Medical Sciences (DMIMS), Wardha; and BMC COVID Centre, Mumbai involved 70 participants in each arm.
Chopra, also honorary chief clinical coordinator of the Ministry of AYUSH-CSIR collaboration, said AYUSH-64 as an adjunct to standard of care (SoC) showed significant improvement and thus lesser period of hospitalization as compared to SoC alone.
He said several significant beneficial effects of the drug on general health, fatigue, anxiety, stress, appetite, general happiness and sleep were also observed.
"The drug's trial study has provided substantial evidence that AYUSH-64 can be effectively and safely used to treat mild to moderate cases of COVID-19 as adjuvant to SoC," he said.
The official, however, said patients on AYUSH-64 drug will still require monitoring so as to identify any worsening of disease requiring more intensive therapy with oxygen and other treatment measures provided during hospitalization.
"It is useful in the treatment of asymptomatic, mild, and moderate COVID-19 infection as an adjunct to standard care. It is worthwhile to mention that initially the drug was developed for malaria in the year 1980 and now is repurposed for COVID-19," he said.
The Ayush-CSIR Joint Monitoring Committee has also recommended the ministry to communicate to state licensing authorities/regulators regarding adding new indication of AYUSH-64 for repurposing in the management of mild to moderate COVID-19.
"It is extensively studied, scientifically developed, safe, and effective Ayurveda formulation. This medicine is also recommended in the National Clinical Management Protocol based on Ayurveda and Yoga, which is vetted by the National Task Force on COVID-19 Management of ICMR," the ministry said.
V M Katoch, former director-general, Indian Council of Medical Research (ICMR), said the committee has carefully reviewed the outcome of AYUSH-64 study and recommended the use of the drug in the management of asymptomatic, mild to moderate COVID-19 cases.
N Srikanth, Director General, Central Council for Research in Ayurvedic Sciences (CCRAS) noted that additional studies on the drug are underway at reputed research institutes.
"Results received so far have shown the usefulness of AYUSH-64 in dealing with mild and moderate COVID-19. The outcome of seven clinical studies has also revealed that the drug exhibits early clinical recovery in COVID-19 cases without further progression. In all the clinical studies, the drug was found to be well-tolerated and found clinically safe," he said.