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AYUSH-64 as an add-on to standard care in asymptomatic and mild cases of COVID-19: A randomized controlled trial
| Content Provider | Scilit |
|---|---|
| Author | Rai, Amit Kumar Gosavi, Rajesh Vithal Yadav, Babita Holay, Madhuri Prashant Talekar, Manisha Khanduri, Shruti Rana, Rakesh Tripathi, Arunabh Srikanth, NarayanaM Dhiman, Kartar S. Reddy, R. Govind Jameela, Sophia Sharma, Bhagwan Sahay Chandrasekhararao, Bhogavalli |
| Copyright Year | 2020 |
| Abstract | Background: The evidence on the efficacy and safety of Ayurveda interventions as an add-on to the standard conventional care for coronavirus disease-2019 (COVID-19) is limited. Aim and objective: This study was planned to explore the potential of AYUSH-64 as an add-on to conventional care in improving the clinical recovery and negative reverse transcription–polymerase chain reaction (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 groups (CG) in a 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 (IG), while the CG received only standard care. The primary outcome was the proportion of participants who turned RT-PCR negative for COVID-19 at $7^{th}$, $15^{th}$, $22^{nd}$ and $30^{th}$ days. Secondary outcomes were the proportion of participants who attained clinical recovery at $7^{th}$, $15^{th}$, $22^{nd}$ and $30^{th}$ days, change in laboratory parameters on the $30^{th}$ day and incidence of adverse drug reactions/adverse events. The data were 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 in terms of complete relief in 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 CG, respectively. The improvement in the inflammatory markers such as interleukin (IL)-6, tumor necrosis factor-α (TNF-α), and D-dimer was statistically significant (P < 0.05) in the IG, whereas in the CG, it was statistically significant for D-dimer only. None of the participants developed any complications nor were any significant ADR/AE observed in the groups. Conclusions: In patients with asymptomatic and mild COVID-19, AYUSH-64, as add-on to standard conventional care, contributed to improved clinical recovery and demonstrated potential in reducing the levels of pro-inflammatory markers such as IL-6 and TNF-α. Further, both the groups demonstrated comparable efficacy regarding negative RT-PCR for COVID-19. |
| Related Links | https://www.ayujournal.org/article.asp?issn=0974-8520;year=2020;volume=41;issue=2;spage=107;epage=116;aulast=Reddy;type=2 |
| File Format | XHTML |
| ISSN | 09748520 |
| e-ISSN | 09769382 |
| DOI | 10.4103/ayu.ayu_14_21 |
| Journal | Ayu |
| Issue Number | 2 |
| Volume Number | 41 |
| Language | English |
| Publisher | Medknow |
| Access Restriction | Open |
| Subject Keyword | Integrative and Complementary Medicine Ayurveda Ayush-64 Coronavirus Disease-2019 Pandemic Sars-cov-2 Ayu, Volume 41, Issue 2 |
| Content Type | Text |
| Resource Type | Article |
