Adverse events (AE) in the two study groups* (n = 139).
loss of taste and/or smell, poisoning, fever, fatigue, myalgias, Disorders of blood and lymphatic, immune system, hyperglycemia, psychiatric, breathlessness, dyslipidemia, Transaminitis, congenital familial
HYPERGLYCEMIA, DRUG INTERACTION, COMPLICATIONS, DYSLIPIDEMIA
(1) Abbreviations: AYUSH Plus: AYUSH 64 plus Standard of Care (SOC); n: number of participants; GIT: gastrointestinal(2) Clinical grading as per WHO classification(3) Causality in the AYUSH plus pertained to AYUSH 64 drug while causality in the SOC arm was not specified to any particular drug(4) Transaminitis: raised serum glutamic oxalacetate and or pyruvate(5) No AE recorded for Disorders of blood and lymphatic, immune system, metabolism and nutrition, psychiatric, reproductive system and breast, eye, vascular system, congenital familial and genetic, injury poisoning and procedural complications, and surgical and medical procedures(6)See Text and AE were generally mild in nature and pertained to episodic fever, myalgias, fatigue, occasional breathlessness, loss of taste and/or smell and were mostly reported during the post-hospitalization follow-up. Several AE were possibly symptoms of COVID-19 rather than due to any study drug. A probable or definite causality of AE with AYUSH 64 could not be confirmed in any of the study participants. However, based on a-priori knowledge and experience of the Ayurvedic physicians in the study, some of the gut-related AE, albeit mild, which were present in the AYUSH plus may have been due to AYUSH 64 medication. Most of the time, AE did not require any specific treatment. Three participants reported serious AE and all recovered without any complications. Moderate AE was treated symptomatically. Those suspected of severe AE were referred to a specialist for an opinion. Participants with naïve hyperglycemia and/ or dyslipidemia were managed by a specialist physician.Clinically, none of the AE was related to a drug interaction.Repeated routine laboratory assays remained within normal limits in the two arms and there were no significant differences between the treatment arms Table S7.1 in 