Withdrawals
deaths, respiratory distress, pneumonia, neuropathy
PNEUMONIA, GUILLAIN BARRE SYNDROME, NEUROPATHY
Three participants were withdrawn during the randomization phase -one participant withdrew consent following randomization, one (AYUSH Plus) developed neuropathy (Guillain Barre syndrome) and one (SOC) developed severe pneumonia with respiratory distress. 137 patients completed the randomized treatment phase. A total of 20 (14.3%) participants withdrew (12 in the SOC group and 8 in the AYUSH Plus group) from the study. Seventeen patients did not wish to continue following complete recovery and hospital discharge. The latter did not report any AE during an informal follow up. None of the withdrawals were due to a drug related AE. There were no deaths in the study.