Ayush-CSIR joint study demonstrates safety, efficacy of AYUSH 64 in mild to moderate Covid-19

The scientists of reputed research institutions of the country have found that AYUSH 64, a poly herbal formulation developed by the Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of Ayush 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.

The Ministry of Ayush-Council of Scientific and Industrial Research (CSIR) collaboration has recently completed a robust multi-centre clinical trial to evaluate the safety and efficacy of AYUSH 64 in the management of mild to moderate COVID-19 patients.

AYUSH 64 comprises of Alstonia scholaris (aqueous bark extract), Picrorhiza kurroa (aqueous rhizome extract), Swertia chirata (aqueous extract of whole plant) and Caesalpinia crista (fine-powdered seed pulp). It is extensively studied, scientifically developed, safe and effective Ayurveda formulation. This medicine is also recommended in National Clinical Management Protocol based on Ayurveda and Yoga which is vetted by National Task Force on COVID-19 Management of ICMR.

Dr Arvind Chopra, Director, Centre for Rheumatic Diseases, Pune and honorary chief clinical coordinator of the Ministry of Ayush - CSIR collaboration informed that the trial was conducted at three centres. KGMU, Lucknow; DMIMS, Wardha and BMC COVID Centre, Mumbai involving 70 participants in each arm. Dr Chopra stated that AYUSH 64 as an adjunct to standard of care (SoC) showed significant improvement and thus lesser period of hospitalization as compared SoC alone. He also shared that several significant beneficial effects of AYUSH 64 on general health, fatigue, anxiety, stress, appetite, general happiness and sleep were also observed. Dr. Chopra concluded that this controlled drug 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 also added that, patients on AYUSH 64 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.

Dr. Bhushan Patwardhan, National Research Professor, Ayush and Chairman of the Inter-disciplinary Ayush Research and Development Task Force on COVID-19 stated that the results of AYUSH-64 study are highly encouraging and in the current crisis situations needy patients should be able to get benefits of Ayush 64. He also underlined that this multi-centre trial was monitored by Ayush-CSIR Joint Monitoring Committee (MC) under the chairmanship of Dr. V M Katoch, former Secretary, Department of Health Research and former Director General, Indian Council of Medical Research (DG, ICMR). He further added that these clinical studies periodically reviewed by an independent Data and Safety Management Board (DSMB).

Dr. V M Katoch, Chairman of the MC informed that the committee has carefully reviewed the outcome of AYUSH 64 study and recommended AYUSH 64 in the management of asymptomatic, mild to moderate COVID-19. It is worthwhile to note that this committee has also recommended Ministry to communicate to the state licensing authorities/regulators regarding adding new indication of AYUSH 64 for repurposing in the management of mild to moderate COVID-19.

Dr. N. Srikanth, Director General, CCRAS elaborated that additional studies on Ayush 64 are underway at reputed research institutes including CSIR-IIIM, DBT-THSTI, ICMR-NIN, AIIMS Jodhpur and Medical Colleges including Post Graduate Institute of Medical Education & Research, Chandigarh; King George's Medical University, Lucknow; Government Medical College, Nagpur; Datta Meghe Institute of Medical Sciences, Nagpur. Results received so far have shown the usefulness of AYUSH 64 in dealing with mild and moderate COVID-19. He also added that the outcome of the seven clinical studies has revealed that AYUSH 64 exhibits early clinical recovery in COVID-19 cases without further progression. In all clinical studies, AYUSH 64 was found to be well tolerated and found clinically safe.