Coadministration of AYUSH 64 as an adjunct to Standard of Care in mild and moderate COVID-19: A randomised, controlled, multicentric clinical trial

Abstract

Objectives: To compare the co-administration of an Ayurvedic drug AYUSH 64 as an adjunct to standard of care (SOC) and SOC for efficacy and safety in the management of COVID-19. Design: Multicentre, parallel efficacy, randomized, controlled, open-label, assessor blind, exploratory trial with a convenience sample. Patients followed to complete 12 weeks of study duration. Setting: COVID-19 dedicated non-intensive care wards at 1 government hospital, 1 medical college teaching hospital and 1 medical university teaching hospital Participants: 140 consenting, eligible, hospitalized adult patients suffering from mild and moderate symptomatic COVID-19 and confirmed by a diagnostic (SARS-CoV-2) RT-PCR assay on nasal and throat swab were randomized to SOC or SOC plus AYUSH 64. To be withdrawn if the disease becomes severe. Interventions: Two tablets of AYUSH 64, 500 mg each, twice daily after meals, and continued till study completion. SOC (symptomatic and supportive) as per national guidelines of India for mild and moderate disease. Main outcome measures: Time period to clinical recovery (CR) from randomization baseline and proportion with CR within 28 days time frame; CR defined in the protocol Results: 140 patients randomized (70 in each arm); 138 patients with CR qualified for analysis. Both groups were matched at baseline. The mean time to CR from randomization was significantly superior in AYUSH 64 group (95% CI -3.03 to 0.59 days); a higher proportion (69.7%) in the first week (p=0.046, Chi-square). No significant differences observed for COVID-19 related blood assays (such as D-Dimer). AYUSH 64 arm showed significant (p<0.05) superior persistent improvement in general health, quality of life, fatigue, anxiety, stress, sleep, and other psychosocial metrics. 1 patient on SOC required critical care. 48 adverse events (AE) reported in each group. Barring three SAE (in SOC), AE were mild and none were drug-related. 22 participants (8 on AYUSH) were withdrawn. No deaths were reported. Conclusions: AYUSH 64 hastened recovery, reduced hospitalization, and improved overall health in mild and moderate COVID-19 when co-administered with SOC under medical supervision. It was safe and well-tolerated. Further studies are warranted. Trial registration: The Clinical Trials Registry India Number CTRI/2020/06/025557 Funding: CCRAS, Ministry of AYUSH, Government of India

Efficacy and Safety of Ayurveda Intervention (AYUSH 64) as add-on therapy for patients with COVID-19 infections – An open labelled, Parallel Group, Randomized controlled clinical trial

“…A similar study using Ayush -64 in addition with the standard treatment is now published as preprint and it shows significant beneficial effect of this intervention for COVID -19 when it was given with standard treatment in comparison to the placebo group. [22] In this study, two primary endpoints i.e mean duration of time to first day of clinical recovery was significantly less in intervention group as compared to the control group and proportion of patients with full clinical recovery was more in the intervention group as compared to the control. Quality of life score was also better in the Ayush -64 group.…”

“…There was no significant different in laboratory parameters. [22] This study has large sample size in comparison to our study though it was convenient only and exact sample size was not calculated. We have chosen the minimal sample size considering it as a new drug being explored in the disease first time and there was a plan to extend the study further if safety is established in the small sample size but it could not be done due to unavailability of the patients.…”

“…It shows that the drug has adequate safety in humans with the current dosing schedule. [22] COVID -19 is a disease associated with high morbidity and there is need of exploration of effective interventions to prevent and treat this disease on urgent basis which can be attempted if potential therapeutic interventions from modern medicines or complementary and alternative system are explored on fast-track basis. Our study was an attempt in this direction.…”

Disease Characteristics, Care-Seeking Behavior, and Outcomes Associated With the Use of AYUSH-64 in COVID-19 Patients in Home Isolation in India: A Community-Based Cross-Sectional Analysis

“…Death as a complication of COVID-19 was observed in a minimal number of participants in the study. This may be considered a good outcome, and coupled with the evidence from the previous clinical studies in which AYUSH-64 as an adjunct to conventional standard care demonstrated better clinical recovery with no disease progression compared to standard care alone in COVID-19 (11)(12)(13)(14)(15)(16), it is possible to say that AYUSH-64 use in COVID-19 may correlate with better clinical outcomes even if used alone. Adverse events reported in this community study were very minimal, and none of the events required the need for medical consultation or hospitalization.…”

“…The experimental studies also demonstrated immunomodulating and anti-inflammatory activities of the constituents of AYUSH-64 (5)(6)(7)(8)(9)(10). Based on the clinical evidence on the therapeutic potential of AYUSH-64 in COVID-19 generated through multiple clinical trials, AYUSH-64 was positioned as a potential adjunct to standard care in COVID-19 management (11)(12)(13)(14)(15)(16). It was recommended for the management of asymptomatic and mild COVID-19 in the National Clinical Management Protocol based on Ayurveda and Yoga issued by the MoA, India (2).…”