AYUSH-64 as an adjunct to standard care in asymptomatic, mild, and moderate COVID-19: A systematic review and meta-analysis

The study was planned to systematically review the available evidence from randomized controlled trials on the efficacy and safety of AYUSH-64 in managing COVID-19. Electronic databases such as PubMed, Ayush Research Portal, DHARA, Cochrane CENTRAL, etc. were searched from December 2019 to October 2021, and updated in February 2022. The risk of bias was assessed through the RoB2 tool. Meta-analysis was done with the Review Manager 5.4 tool. The quality of cumulative evidence was evaluated through the GRADE approach. This study includes five RCTs with 420 participants. The risk of bias was assessed as low for most of the studies. The results demonstrated that AYUSH-64 administration as an adjunct to standard care was significantly better compared to standard care alone for asymptomatic, mild, and moderate COVID-19 in terms of clinical recovery (OR= 2.35; 95% CI= 1.33 to 4.16; p=0.003), and mean time to clinical recovery (SMD= -0.67; 95% CI= -1.16 to -0.18; p=0.007). There was no statistically significant difference between groups in SARS-CoV-2 clearance assessed by RT-PCR assay (OR= 1.21; 95% CI= 0.51 to 2.88; p=0.66). The overall incidence of adverse events showed no significant difference between groups (p=0.65). The quality of evidence was assessed as moderate for clinical recovery and low for SARS-CoV-2 clearance. Meta-analysis of five RCTs demonstrated that AYUSH-64 as an adjunct to standard care hastens clinical recovery and is safe in asymptomatic, mild, and moderate COVID-19. However, more robust RCTs would be required to generalize the results of this systematic review

Effect of an Ayurvedic intervention (Ayush-64) in mild to moderate COVID-19: An exploratory prospective single arm clinical trial

Background: Ayush-64 is an Ayurvedic formulation, developed and patented by Central Council of Research in Ayurvedic Sciences (CCRAS). In the present study, we repurposed it for use in mild to moderate COVID-19 cases based on a pilot study against Influenza like illness (ILI) and molecular docking study which revealed that several compounds isolated from Ayush-64 demostrated antiviral activity. Purpose: To evaluate the role of Ayush-64 in clinical recovery of mild to moderate COVID-19 pattients Study Design: A single arm, pilot study in mild to moderate COVID-19 patients Methods: The study was conducted from 20th June, 2020 to 11th August, 2020 at Chaudhary Brahm Prakash Ayurved Charak Sansthan (CBPACS), New Delhi, India involving 37 confirmed COVID-19 participants. Ayush 64 tablets in the dose of two tablets (500 mg each) thrice daily was given to the participants for a duration of either 8 or 14 days. Number of participants showing ‘clinical recovery’ was set as primary outcome. Percentage of participants with negative SARS-CoV-2 on nasal or throat swab in a 2-day consecutive real time RT-PCR test was evaluated as secondary outcome. Result: In the study 86.1% participants have shown clinical recovery after 14 days intervention of Ayush-64, out of which 75% clinically recovered within 7 days. Finding of RT-PCR test has shown that 69.4% participants turned negative till 15th day, out of which 50% became negative on 8th day. No AE/ ADR was observed during the course of the study. Conclusion: Ayush-64 is a safe treatment option in mild to moderate COVID-19 cases and is likely to significantly facilitate clinical improvement in terms of duration for clinical recovery and attaining negative conversion, without any ADR/AE

AYUSH-64 as add-on to standard care in asymptomatic and mild cases of COVID-19: A randomized controlled trial

Background: The evidence on the efficacy and safety of Ayurveda interventions as add-on to the standard conventional care for COVID-19 is limited. This study was planned to explore the potential of AYUSH-64 as add-on to conventional care in improving the clinical recovery and negative RT-PCR conversion in asymptomatic and mild COVID-19 cases. Materials and Methods: An open-label randomized controlled study was conducted at Government Medical College, Nagpur, Maharashtra, India with a sample size of 60 participants. In this study, asymptomatic or mild COVID-19 patients were randomized and allocated into intervention and control group in 1:1 ratio. AYUSH-64 two capsules (500 mg each) were administered thrice daily, after food with water for 30 days along with standard care in the intervention group, while the control group received only standard care. The effect of the interventions was assessed in terms of negative RT-PCR for COVID-19, clinical cure rate and inflammatory cytokines. Outcome measures: Primary outcome was the time to attain negative RT-PCR for COVID-19 and proportion of participants turned RT-PCR negative for COVID-19 at 7th, 15th, 22nd and 30th day respectively in the intervention group compared to the control group. Secondary outcomes were the proportion of participants who attained clinical recovery at 7th, 15th, 22nd, and 30thday; improvement in laboratory parameters on the 30th day (as compared to baseline) and incidence of Adverse Drug Reactions/Adverse Events (ADRs/AEs). The data was compared within group using paired sample t-test/ Wilcoxon signed rank test and between group using independent sample t-test/Mann-Whitney test. Results: Statistically significant difference was not observed in the proportion of participants who turned RT-PCR negative during each of the follow-ups (p=0.134) and both groups demonstrated comparable efficacy. The clinical recovery rate in terms of time taken for complete cure of symptoms in the symptomatic participants was 60% and 37% on day 15 (p=0.098) and 100% and 85.2% on day 30 (p=0.112), in the intervention and control group respectively which is numerically a better clinical outcome in the intervention group. The improvement in the inflammatory markers such as IL-6, TNF-α and D-dimer was statistically significant in the intervention group (p<0.05). None of the participants developed any complications nor were any significant ADR/AE observed in both the groups. Conclusion: In patients with asymptomatic and mild COVID-19, AYUSH-64 as add-on to standard conventional care, contributed to improving the duration for attaining complete clinical cure and demonstrated potential in reducing the levels of pro-inflammatory markers in the body

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

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

Perception and practices followed by AYUSH practitioners and health seekers for prevention of COVID-19: Cross-sectional analysis of an app-based data

Abstract AYUSH Sanjivani is a mobile application launched by the Ministry of AYUSH (MoA) to gather information regarding the utilization of AYUSH (Ayurveda, Yoga, Unani, Siddha, and Homeopathy) advocacies for the prevention of COVID-19 infection. A cross-sectional analysis of the data generated through this mobile application has been performed and presented in this article to examine the acceptability and extent of utilization of AYUSH preventive measures in India. Objectives: The objectives of this cross-sectional analysis was to determine the trends of the utilization of AYUSH measures by the beneficiaries as reported by AYUSH practitioners and by the practitioners themselves for the prevention of COVID-19 and to determine the benefit obtained in terms of self-reported parameters of general well being, the overall impact on general health and in preventing the onset of flu-like symptoms. Methods: A secondary data analysis was undertaken, utilizing the cross-sectional data generated through the AYUSH Sanjivani App from May to July 2020. The responses in terms of demographic profile, utilization pattern, benefits obtained, the interventions used and the data of beneficiaries in terms of geographic location and interventions prescribed were analyzed statistically to assess the trends of the utilization of AYUSH measures for prophylaxis. Results: Data of 74,568 AYUSH physicians and 1,35,21,245 beneficiaries/health seekers whose data were reported by 3623 AYUSH practitioners were used for analysis. AYUSH advocacies/measures were utilized by 69,195 (92.8%) physicians for prophylaxis. Samshamani Vati, Chyavanprash, and Arsenicum Album-30 were the most commonly used AYUSH interventions. Improvement in terms of appetite, bowel movements, sleep, mental well being, stamina, change in pre-existing disease, and change in disposition were reported by 42400 (61.3%) physicians. Maximum beneficiaries were from the state of Gujarat followed by Madhya Pradesh. Arsenicum Album-30 was the most commonly prescribed/distributed intervention among the beneficiaries/ health seekers. Conclusion: Maximum physicians have reported having benefited from the use of AYUSH prophylactic measures for the prevention of COVID-19. Moreover, a good proportion of the Indian population was provided the AYUSH prophylactic measures as recorded in the app

Infective Endocarditis in Patients on Chronic Hemodialysis

International audienceInfective endocarditis (IE) is a common and serious complication in patients receiving chronic hemodialysis (HD)

Infective Endocarditis After Transcatheter Versus Surgical Aortic Valve Replacement

Abstract Background Scarce data are available comparing infective endocarditis (IE) following surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). This study aimed to compare the clinical presentation, microbiological profile, management, and outcomes of IE after SAVR versus TAVR. Methods Data were collected from the “Infectious Endocarditis after TAVR International” (enrollment from 2005 to 2020) and the “International Collaboration on Endocarditis” (enrollment from 2000 to 2012) registries. Only patients with an IE affecting the aortic valve prosthesis were included. A 1:1 paired matching approach was used to compare patients with TAVR and SAVR. Results A total of 1688 patients were included. Of them, 602 (35.7%) had a surgical bioprosthesis (SB), 666 (39.5%) a mechanical prosthesis, 70 (4.2%) a homograft, and 350 (20.7%) a transcatheter heart valve. In the SAVR versus TAVR matched population, the rate of new moderate or severe aortic regurgitation was higher in the SB group (43.4% vs 13.5%; P < .001), and fewer vegetations were diagnosed in the SB group (62.5% vs 82%; P < .001). Patients with an SB had a higher rate of perivalvular extension (47.9% vs 27%; P < .001) and Staphylococcus aureus was less common in this group (13.4% vs 22%; P = .033). Despite a higher rate of surgery in patients with SB (44.4% vs 27.3%; P < .001), 1-year mortality was similar (SB: 46.5%; TAVR: 44.8%; log-rank P = .697). Conclusions Clinical presentation, type of causative microorganism, and treatment differed between patients with an IE located on SB compared with TAVR. Despite these differences, both groups exhibited high and similar mortality at 1-year follow-up