AYUSH-64 as an adjunct to Standard Care in mild to moderate COVID-19: An open-label randomized controlled trial in Chandigarh, India

Abstract

Background: There is limited evidence on the safety and efficacy of administering Ayurveda interventions as add-on to the standard care for COVID-19. Objective: To explore the therapeutic efficacy and safety of AYUSH-64 as an add-on to standard care in the management of mild to moderate stage COVID-19.Design, setting, participants and interventions: This was an open-label randomized controlled trial with 80 patients of mild to moderate stage COVID-19. Participants in the AYUSH-64 add-on group received two tablets (500 mg each) three times daily for 30 days along with conventional standard care (Paracetamol, Cetirizine, Vitamin C, and Azithromycin). The control group received standard care alone. Main outcome measures: The primary outcome assessed was the proportion of participants with clinical recovery and negative RT-PCR assay for COVID-19 on day 7, 15, 23, and 30. Additionally, change in pro-inflammatory markers, metabolic functions, HRCT chest and incidence of Adverse Drug Reaction (ADR) / Serious Adverse Event (SAE) were assessed.Results: Statistically significant difference was observed in the proportion of participants with clinical recovery in the AYUSH-64 add-on group (p<0.001) at each of the scheduled follow-up visits. All the participants in the AYUSH-64 add-on group clinically recovered by day 23 compared to 32.4 per cent in the control group. The mean duration for clinical recovery in AYUSH-64 add-on group (5.8 ± 2.67 days) was less as compared to control group (10.0 ± 4.06 days). The proportion of participants who turned RT-PCR negative for COVID-19 on day 7, 15, and 23 were 81.8, 94.5, and 100 per cent in AYUSH-64 add-on group, and 79.4, 94.5, and 97.2 per cent in control group, however, the difference observed was statistically not significant (p=0.314). The proportion of participants with improvement in HRCT chest was statistically significant in AYUSH-64 add-on group (p=0.031) unlike in control group (p=0.210). Similar reductions in most inflammatory markers measured (IL-6, CRP, Serum ferritin, and LDH) on day 30 (p<0.05) were observed in both groups. Conclusion: AYUSH-64 as adjunct to standard conventional care is safe and hastens clinical recovery in adult patients with mild to moderate COVID-19.

Pharmacological Evaluations of Select Herbal Extracts on TLR7/8-induced Cytokine and Chemokine Production in Macrophage-like Cells

“…Safety studies have confirmed its tolerance up to 500mg/kg body weight in rodents. A clinical trial conducted by the Ministry of AYUSH, India, and the Council of Scientific and Industrial Research, India, demonstrated its efficacy in managing mild to moderate COVID-19 patients, with a significant decrease in IL-6 levels [31,32,25]. In our study, we evaluated the effect of A-64 on the expression of inflammatory genes in the presence of TLR7/8 inducers (Figure 7).…”