ABSTRACT
Background: Currently, there is no approved treatment for the management of coronavirus disease (COVID-19). Drug repurposing of existing medications could be a possible way to find out a novel therapeutic entity to combat the COVID-19. Aim: To determine the clinical efficacy and safety of an Ayurveda intervention (Guduchighana Vati) in asymptomatic and mild-to-moderate cases of COVID-19. Materials and methods: This was an open-label randomized controlled pilot study with a sample size of 30 participants (15 in each arm). The participants were asymptomatic or mild to moderate cases of COVID-19. Guduchighana Vati 500 mg twice daily for 10 days was administered in the study group and Hydroxychloroquine for 5 days in the control group. Paracetamol, Vitamin C, Multivitamin, and Zinc were also provided in the control group. The main outcome measures were to negative real-time reverse transcription-polymerase chain reaction (RT-PCR) assay for COVID-19, proportion of participants with negative RT-PCR for COVID-19 at 5th and 10th day, proportion of participants with clinical recovery, improvement in laboratory parameters, and incidence of adverse drug reaction/adverse event (ADR/AE). The results of RT-PCR and clinical recovery were compared between groups using Chi-square test. The data related to laboratory parameters were compared within group using paired sample t-test/Wilcoxon signed-rank test and between groups using independent sample t-test/Mann-Whitney test. Results: The proportion of participants with negative RT-PCR for COVID-19 in the Guduchighana Vati group (93.3%) was better as compared to the control group (66.6%) till 10th day of the study period. Though, the results are statistically not significant (P = 0.068). All the symptomatic patients in the Guduchighana Vati group clinically recovered whereas one patient remained symptomatic in the control group on the 5th day. No symptoms of COVID-19 were observed at 10th day in both the groups. No ADR/serious adverse event were observed during the study period in either of the groups. Conclusion: In this study on asymptomatic and mild to moderate cases of COVID-19, Guduchighana Vati showed numerically better proportion of participants with negative RT-PCR assay for COVID-19 and reduced time to clinical improvement which requires confirmation through studies with larger sample size. Although, the study outcomes are statistically not significant which may be due to small sample size.
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 7th, 15th, 22nd and 30th days. Secondary outcomes were the proportion of participants who attained clinical recovery at 7th, 15th, 22nd and 30th days, change in laboratory parameters on the 30th 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.