Impact of AYUSH 64 as an adjunctive to standard of care in mild COVID 19 - An open-label randomized controlled pilot study

Thakar, Anup B; Goyal, Mandip; Bhinde, Sagar; Chhotala, Yagnik; Panara, Kalpesh; Chaudhari, Swapnil

doi:10.1016/j.jaim.2022.100587

Cited by 8 publications

(16 citation statements)

References 14 publications

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“…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.…”

Section: Factors Associated With Participant Preference For Ayush-64 ...mentioning

confidence: 76%

“…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).…”

Section: Introductionmentioning

confidence: 99%

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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

Srikanth

Kumar

Chandrasekhararao

et al. 2022

Front. Public Health

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BackgroundDuring the second wave of the COVID-19 pandemic in India, the Ministry of Ayush conducted a community study to provide therapeutic care to patients with asymptomatic, mild, and moderate COVID-19 in home isolation based on the empirical evidence generated on the efficacy of AYUSH-64 in COVID-19.ObjectiveTo document disease characteristics, care-seeking behavior, and outcomes in patients with asymptomatic, mild, or moderate COVID-19 in home isolation who used AYUSH-64 for COVID-19.MethodsCross-sectional analysis of the data generated through a community study conducted in India from 08 May to 31 August 2021 was performed to study the disease characteristics, care-seeking behavior during home isolation, clinical outcomes, adverse events, and the association between various risk factors and clinical recovery during the study period. The data were collected through semi-structured questionnaires, available in electronic data collection format at the baseline, 7, 14, and 21 days. A logistic regression was performed to explore the relationship between relevant variables and clinical recovery.ResultsData from 64,642 participants were analyzed for baseline assessment, and final analysis was done for 49,770 participants. The mean age of the enrolled participants was 38.8 ± 11.7 years, and 8.4% had co-morbidities. AYUSH-64 was utilized as an add-on to the standard care by 58.3% of participants. Comparable clinical outcomes were observed in participants utilizing AYUSH-64 either as a standalone or as an add-on to standard care, in terms of clinical recovery, disease progression, the requirement for oxygen supplementation, hospitalization, ICU admission, and need for ventilator support. Younger age, having no co-morbidities or substance abuse, and having been vaccinated were associated with early clinical recovery than those who were older and not vaccinated.ConclusionsThe study findings suggest that AYUSH-64 use, either standalone or as an adjunct to standard care, in asymptomatic, mild, or moderate COVID-19 is associated with good clinical outcomes. Ayush services and interventions can be effectively integrated into the mainstream public health architecture to serve public health goals.

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Section: Factors Associated With Participant Preference For Ayush-64 ...mentioning

confidence: 76%

Section: Introductionmentioning

confidence: 99%

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

Srikanth

Kumar

Chandrasekhararao

et al. 2022

Front. Public Health

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“…Similarly, no drug-related AEs or SAEs were observed in patients utilizing the polyherbal AYUSH 64 formulation. None of the participants required invasive or non-invasive oxygen ventilation or developed complications such as acute respiratory distress syndrome, sepsis, or arrhythmia during the study period [ 27 ]. Thus, the results mentioned above, along with the present study, suggest that herbal interventions were relatively safe for the management of COVID-19.…”

Section: Discussionmentioning

confidence: 99%

The Efficacy and Safety of Imusil® Tablets in the Treatment of Adult Patients With Mild COVID-19: A Prospective, Randomized, Multicenter, Open-Label Study

Abhyankar¹,

Dilip²,

Reddy³

et al. 2023

Cureus

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Introduction Coronavirus disease 2019 (COVID-19) is a serious concern of the new era. Along with antiviral synthetic medications, there is a need to discover efficacious herbal antiviral medicines with minimum side effects in patients against COVID-19. This study aimed to assess the efficacy and safety of Imusil® among patients with mild COVID-19. Methods A prospective, randomized, multicenter, open-label, interventional study was conducted in patients with mild COVID-19 infection. Patients received either Imusil one tablet four times a day (seven days) along with the standard of care (SoC) or only SoC. The study endpoints were reverse transcription-polymerase chain reaction (RT-PCR) negativity, changes in cycle threshold (CT), clinical improvement, change in blood inflammatory indexes, and safety assessment. Results A total of 100 patients were enrolled, and 98 received at least one dose of treatment. The median age of patients was 36.0 years, and 58 were males. By day 4, 85.4% of patients in the Imusil+SoC group tested negative for RT-PCR compared to 64% of patients exhibiting the same outcome in the SoC group (P=0.0156). After eight days, clinical improvement was observed in all patients from the Imusil+SoC group, while in the SoC group, clinical improvement was observed in 94.0% of patients (P=0.4947). During follow-up visits, the average C-reactive protein (CRP) levels decreased from baseline in both treatment groups. The decrease in the levels of CRP (-7.3 mg/dL versus -5.5 mg/dL), D-dimer (-231.0 ng/mL versus -151.6 ng/mL), and interleukin 6 (IL-6) (-2.3 pg/mL versus -2.0 pg/mL) at eight days was comparatively higher in the Imusil+SoC group versus the SoC group. There were no serious treatment-emergent adverse events in the drug arm. Conclusion Imusil provides effective antiviral activity and safety in mild COVID-19 patients. Imusil ensures faster RT-PCR negativity and clinical improvement and ensures effective reduction of inflammatory markers such as CRP, D-dimer and interleukin 6.

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“…Safety studies have con rmed its tolerance up to 500mg/kg body weight in rodents. A clinical trial conducted by the Ministry of AYUSH, India, and the Council of Scienti c and Industrial Research, India, demonstrated its e cacy in managing mild to moderate COVID-19 patients, with a signi cant decrease in IL-6 levels [25,31,32]. In our study, we evaluated the effect of A-64 on the expression of in ammatory genes in the presence of TLR7/8 inducers (Fig.…”

Section: Titration Of Agonist Concentration and Treatment Durationmentioning

confidence: 99%

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

Dagar,

Priya,

Dikshit

et al. 2023

Preprint

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Inflammation is an innate immune response triggered by harmful stimuli, such as pathogens, tissue injury, or toxins. The purpose is to eliminate the source of infection and initiate the healing process. However, an excessive acute inflammatory response can lead to severe and life-threatening complications, as seen during recent pandemics. In the context of viral infections, the activation of the TLR7/8 signaling pathway has been implicated in excessive cytokine secretion. In this study, we aimed to replicate the perturbed inflammatory environment resulting from the activation of the TLR7/8 specific agonists, imiquimod, and resiquimod. We utilized macrophage-like cells, as macrophages are the first responders during infections and secrete key pro-inflammatory cytokines (TNF-α, IL-6, and IL-1β) to recruit immune cells to the site of infection. Herbal medicines have been traditionally used for centuries to enhance respiratory immune function. In the present study, we employed a prophylactic approach, where macrophage-like THP1 cells, differentiated with PMA, were pre-treated with select herbal extracts/formulations prior to TLR7/8 activation in the presence of agonists. Several medicinal plants and formulations known for their therapeutic potential in respiratory ailments were investigated, including Withania somnifera, Tinospora cordifolia, Glycyrrhiza glabra, and AYUSH-64, an herbal formulation. The gene expression and corresponding secreted levels of various inflammatory mediators were measured using RT-PCR and ELISA methods, respectively, in treated and untreated differentiated THP1 cells induced with TLR7/8 agonists. Comparatively, the gene expression of inflammatory markers was significantly higher in resiquimod-induced cells than in imiquimod-treated cells. Notably, Withania somnifera demonstrated pronounced prophylactic efficacy compared to other herbs/formulations, as evidenced by reduction in expression of majority of investigated inflammatory marker genes.

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Impact of AYUSH 64 as an adjunctive to standard of care in mild COVID 19 - An open-label randomized controlled pilot study

Cited by 8 publications

References 14 publications

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

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

The Efficacy and Safety of Imusil® Tablets in the Treatment of Adult Patients With Mild COVID-19: A Prospective, Randomized, Multicenter, Open-Label Study

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

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