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

Reddy, R. Govind; Gosavi, Rajesh V.; Yadav, Babita; Kumar, Amit; Holay, Madhuri; Talekar, Manisha; Jameela, Sophia; Sharma, Bhagwan Sahai; Khanduri, Shruti; Rana, Rakesh; Tripathi, Arunabh; Chandrasekhararao, Bhogavalli; Srikanth, Narayanam; Dhiman, Kartar Singh

doi:10.31219/osf.io/pgraf

Cited by 10 publications

(18 citation statements)

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“…Other contemporary studies of AYUSH-64 for COVID-19 have also reported early clinical recovery and reduction in the levels of pro-inflammatory markers in asymptomatic and mild COVID-19 cases [32][33]. Reduction in the levels of pro-inflammatory markers indicates that AYUSH-64 could possibly arrest the inflammatory cascade, thereby seize or stop the progression of the disease to the severe or critical stage.…”

Section: Discussionmentioning

confidence: 86%

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

Singh¹,

Shrivastva²,

Yadav³

et al. 2021

Preprint

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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.

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Section: Discussionmentioning

confidence: 86%

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

Singh¹,

Shrivastva²,

Yadav³

et al. 2021

Preprint

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“…Ayurveda poly herbal compound AYUSH-64 treating respiratory infection and Malaria approved by Ministry of AYUSH. 19,20 CSIR also developed ACQR for clinical trial against COVID-19. 19,20 National campaign for AYUSH -64 is initiated and targeted to reach all door step through Seva bharati.…”

Section: Discussionmentioning

confidence: 99%

“…19,20 CSIR also developed ACQR for clinical trial against COVID-19. 19,20 National campaign for AYUSH -64 is initiated and targeted to reach all door step through Seva bharati. The AYUSH tool free no 14443 for covid-19 care.…”

Section: Discussionmentioning

confidence: 99%

Ayurveda approaches to COVID-19 in 2 wave: Lessons learned from practice

Panda

Palei²,

Rout³

et al. 2021

JPMHH

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Ayurveda is a live traditional system of medicine with an unbreakable practice since 3000 years. Its principles and its approaches including oral administration of preventive drugs, herbs, formulae, decoction, indoor herbal medicine for fumigation, etc. were recommended for effective prevention and treatment whenever the emergent of new diseases. This paper highlights the patho-physiology of Corona as per Ayurveda, Clinical staging, preventive and curative approaches as learned time to time. and Anu taila nasya have excellent practice evidences for prevention of Covid-19 in 1 wave of corona. Sajeevani app developed by AYUSH to study the AYUSH practices. AYUSH -64 is an evidence-based treatment to cure mild to moderate COVID infection developed by Central Council for Research in Ayurveda Sciences. The second wave of COVID-19 is more tragedy than 1 wave and its impact on health care systems of our nation is devastating and unprecedented. National campaign for AYUSH-64 started and it is recommended in National Clinical Management Protocol based on Ayurveda and Yoga which is vetted by National Task Force on COVID management for COVID-19 Patients in Home Isolation. All Institute of Ayurveda released list of medicines for management of various symptoms of Covid. General public have more trusted upon Ayurveda practitioners as controversies of addition and deletion of steroid and antiviral in modern treatment protocol. The horror of Black (Mucormycosis) and white (Candiditis) fungus infection due to irrational use of immunosuppressive drugs confused the general people. More numbers of Covid patients received AYUSH-64 in 2 wave. Ayurveda Practice requires sound knowledge of Yukti Pramana(Logic and self judgement) by discerning clinical for better outcome irrespective of evidences and guidelines. We all are learning the pathogenesis of different mutants of Covid. Ayurveda approaches reduced the complication and progression of disease. This review will provide basic understanding Ayurveda for covid care.

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“…One report was excluded during the data extraction process, which used AYUSH interventions as a comparator, 16 finally 12 manuscripts were included. [17][18][19][20][21][22][23][24][25][26][27][28] Detail description of the study selection and elimination process has been depicted in figure 1. All the articles were in the English language only.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Among included studies of the therapeutic domain, 2 RCTs examined the benefit of AYUSH-64, 17,18 2 studies (1 RCT, 1 NRSI) of Guduchi Ghanavati, 19,20 each one RCT on different multiple Combinations of Ayurveda medicines (coded as AYUSH regimen-I, II, III, IV, V, VI, and VII). [21][22][23][24][25][26] AYUSH Regimen III and IV were examined in a single RCT.…”

Section: Figure 1: Prisma Flow Chartmentioning

confidence: 99%

AYUSH interventions for COVID-19 - a living systematic review and meta-analysis [First report]

Thakar¹,

Panara²,

Goyal³

et al. 2022

Preprint

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BackgroundIn India, alternative and complementary therapies (AYUSH medicines) are utilized in COVID-19 management extensively. This study was planned to assess the prophylactic and therapeutic effectiveness of AYUSH interventions on COVID-19 through a living systematic review and meta-analysis approach.MethodsDifferent databases like Pubmed; the Cochrane central register of controlled trials; WHO COVID-19 database; the central trial registry - India; Digital Helpline for Ayurveda Research Articles and AYUSH research portal, and pre-print repositories were searched with appropriate search strategies from 1st December 2019 to 1st April 2021. Randomized clinical trials, Non-Randomized Studies of Interventions conducted on the AYUSH system of medicine aimed at either prevention or treatment were included. Clinical improvement, WHO ordinal scale, viral clearance, incidences of COVID-19 infection, and mortality will be considered as primary outcomes. Secondary outcomes will be the use of O2 therapy or mechanical ventilator, admission to high dependency unit or emergency unit, duration of hospitalization, the time to symptom resolution, and adverse events. Data will be synthesized, and the risk of bias will be assessed with RevMan 5.4 tool. The risk of bias of included studies was evaluated by RoB-2 and ROBINS-I tools, and the certainty of the evidence ranked through the GRADE approach.ResultsOf 2,977 studies retrieved, only 12 studies were included in the systematic review. In a moderately certain trial on standalone AYUSH versus Standard care, viral clearance was hastened in the standalone AYUSH group. Add-on AYUSH had shortened time to symptom resolution by about two days compared to standard care with moderate certainty. However, Add-on AYUSH intervention may hasten clinical improvements but has little to no effects on viral clearance. AYUSH prophylaxis may reduce the risk of COVID-19 with low certainty.ConclusionRational use of integrated or standalone AYUSH interventions in mild to moderate COVID-19 patients may provide therapeutic benefits. The effect of AYUSH prophylaxis in the reduction of incidence of COVID-19 in high-risk populations is uncertain. The effect estimates may be changed with additional evidence in upcoming updates.

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

Cited by 10 publications

References 0 publications

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

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

Ayurveda approaches to COVID-19 in 2 wave: Lessons learned from practice

AYUSH interventions for COVID-19 - a living systematic review and meta-analysis [First report]

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