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

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-...

Role of herbal medicines in the management of patients with COVID-19: A systematic review and meta-analysis of randomized controlled trials

“…Seven studies have evaluated the effect of herbal intervention on RT-PCR negativity. 22 , 24 , 27 , 29 , 31 , 35 , 48 The combined treatment with herbal medications and Western medicine showed likely a good effect regarding RT-PCR negativity with effect rate but statistically insignificant (n = 591, RR 1.22, 95% CI 1.00 to 1.44). [See Supplementary Fig.…”

“…Twelve studies reported the effect of herbal intervention on fever as the number of patients with decreased body temperature during the protocol treatment period, represented as Risk Ratio. 16 , 21 , 23 , 24 , 27 , 31 , 37 , 38 , 39 , 44 , 45 , 46 The combination of herbal intervention and Western medicine showed a significant effect with the overall effect rate (n = 850, RR 1.09, 95% CI 1.03 to 1.15). [See Fig.…”

“…Total of seventeen studies have reported the effect on cough. Eleven RCTs 16 , 21 , 23 , 24 , 27 , 37 , 38 , 39 , 44 , 45 , 46 have shown the effect as the number of patients get relief from cough, and the data reported a significant effect as Risk Ratio. (n = 782, RR 1.22 [95% CI 1.08–1.37]; I 2 = 23.5%; p = 0.227) [See Fig.…”

“…Three studies 16 , 23 , 24 have reported the effect as the number of patients without chest pain after treatment and were represented with the effect rate (n = 177, RR 1.12 95% CI 0.75–1.48) [See Fig. 4 C].…”

“…Six studies 16 , 23 , 24 , 27 , 38 , 39 have analyzed the effect as the number of patients without sore throat after treatment (n = 387, RR 1.09 [95% CI 0.99–1.19]; I 2 = 22.1%; p = 0.268). [See Supplementary Fig.…”