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

Singh, Harpreet; Srivastava, Sumit; Yadav, Babita; Amit, Kumar; Jameela, Sophia; Muralidharan, Sanuj; Mohan, Rijin; Chaudhary, Shikha; Singhal, Richa; Rana, Rakesh; Khanduri, Shruti; Sharma, Bhagwan Sahai; Chandrasekhararao, Bhogavalli; Srikanth, Narayanam; Chaturvedi, Sarika

doi:10.1016/j.ctim.2022.102814

Cited by 24 publications

(12 citation statements)

References 29 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 – 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: Discussionmentioning

confidence: 76%

“…The experimental studies also demonstrated immunomodulating and anti-inflammatory activities of the constituents of AYUSH-64 ( 5 – 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 – 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: Discussionmentioning

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

Self Cite

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“…Of the 163 articles identified, 12 studies were reckoned to meet the eligibility criteria and these articles were included for analysis (depicted in Figure 2). Out of 12 studies, 11 studies are conducted in COVID-19 patients [14][15][16][17][18][19][20][21][22][23][24] and 1 study is conducted in post-COVID-19 patients. 25 There are 22 varieties of plants involved as add-on therapy for COVID-19 patients.…”

Section: Resultsmentioning

confidence: 99%

Efficacy and Safety of Add-On Plant-Based Drugs for COVID-19 Patients: A Review of the Randomized Control Trials

Diantini¹,

Febriyanti²,

Levita³

2023

IDR

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COVID-19 caused by the infection of SARS-CoV-2 is still a global concern. WHO reported that from 13 March to 9 April 2023, there were 3 million new cases and approximately 23,000 deaths, mostly occurring in the South-East Asia and Eastern Mediterranean regions, which is predicted due to the new Omicron variant, Arcturus XBB.1.16. Many studies have reported the potency of medicinal plants in enhancing the function of the immune system to combat virus infection. The literature review aimed to describe the efficacy and safety of add-on plant-based drugs for COVID-19 patients. The articles were explored on the PubMed and Cochrane Library databases, and published during 2020-2023. Twenty-two varieties of plants were used as add-on therapy for COVID-19 patients. These plants were

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“…Indeed, it is possible that these two together might compete with each other and exhibit moderate inhibition of CYP2C8 activity. Interestingly, there was no mention of any significant interaction or adverse reaction during the clinical studies conducted with ashwagandha and AYUSH-64 ( Gundeti et al, 2020a ; Reddy et al, 2020 ; Chopra et al, 2021 ; Chopra et al, 2022 ; Singh et al, 2022 ). The HDIs and pharmacokinetic parameters presented in the current study provide insights into having safer therapeutic options for mitigating SARS-CoV-2 as well as their use for the treatment of chronic diseases.…”

Section: Discussionmentioning

confidence: 99%

In vitro effect of Withania somnifera, AYUSH-64, and remdesivir on the activity of CYP-450 enzymes: Implications for possible herb−drug interactions in the management of COVID-19

et al. 2022

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Ayurvedic medicines Withania somnifera Dunal (ashwagandha) and AYUSH-64 have been used for the prevention and management of COVID-19 in India. The present study explores the effect of Ashwagandha and AYUSH-64 on important human CYP enzymes (CYP3A4, CYP2C8, and CYP2D6) to assess their interaction with remdesivir, a drug used for COVID-19 management during the second wave. The study also implies possible herb−drug interactions as ashwagandha and AYUSH-64 are being used for managing various pathological conditions. Aqueous extracts of ashwagandha and AYUSH-64 were characterized using LC-MS/MS. A total of 11 and 24 phytoconstituents were identified putatively from ashwagandha and AYUSH-64 extracts, respectively. In addition, in silico studies revealed good ADME properties of most of the phytoconstituents of these herbal drugs and suggested that some of these might possess CYP-450 inhibitory activity. In vitro CYP-450 studies with human liver microsomes showed moderate inhibition of CYP3A4, 2C8, and 2D6 by remdesivir, while ashwagandha had no inhibitory effect alone or in combination with remdesivir. AYUSH-64 also exhibited a similar trend; however, a moderate inhibitory effect on CYP2C8 was noticed. Thus, ashwagandha seems to be safe to co-administer with the substrates of CYP3A4, CYP2C8, and CYP2D6. However, caution is warranted in prescribing AYUSH-64 along with CYP2C8 substrate drugs. Furthermore, preclinical and clinical PK studies would be helpful for their effective and safer use in the management of various ailments along with other drugs.

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

Cited by 24 publications

References 29 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

Efficacy and Safety of Add-On Plant-Based Drugs for COVID-19 Patients: A Review of the Randomized Control Trials

In vitro effect of Withania somnifera, AYUSH-64, and remdesivir on the activity of CYP-450 enzymes: Implications for possible herb−drug interactions in the management of COVID-19

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