Background: The evidence on the efficacy and safety of Ayurveda interventions as add-on to the standard conventional care for COVID-19 is limited. This study was planned to explore the potential of AYUSH-64 as add-on to conventional care in improving the clinical recovery and negative 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 group in 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, while the control group received only standard care. The effect of the interventions was assessed in terms of negative RT-PCR for COVID-19, clinical cure rate and inflammatory cytokines.Outcome measures: Primary outcome was the time to attain negative RT-PCR for COVID-19 and proportion of participants turned RT-PCR negative for COVID-19 at 7th, 15th, 22nd and 30th day respectively in the intervention group compared to the control group. Secondary outcomes were the proportion of participants who attained clinical recovery at 7th, 15th, 22nd, and 30thday; improvement in laboratory parameters on the 30th day (as compared to baseline) and incidence of Adverse Drug Reactions/Adverse Events (ADRs/AEs). The data was 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 rate in terms of time taken for complete cure of 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 control group respectively which is numerically a better clinical outcome in the intervention group. The improvement in the inflammatory markers such as IL-6, TNF-α and D-dimer was statistically significant in the intervention group (p<0.05). None of the participants developed any complications nor were any significant ADR/AE observed in both the groups.Conclusion: In patients with asymptomatic and mild COVID-19, AYUSH-64 as add-on to standard conventional care, contributed to improving the duration for attaining complete clinical cure and demonstrated potential in reducing the levels of pro-inflammatory markers in the body.
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-...
Background: Strong relationship has been demonstrated between the presence of occlusive CAD and coronary artery calcification (CAC) detected at autopsy, fluoroscopy and computed tomography (CT scan). CT scan quantifies the relative burden of CAC deposits as a marker of atherosclerosis. Study explored utility of multi-slice spiral CT scan for detection of CAC in post myocardial infarction cases.Methods: Fifty-one post myocardial infarction cases were enrolled in the study. Detailed clinical history was recorded in every case regarding age, sex, history of risk factors for CAD like systemic hypertension, diabetes mellitus, smoking and family history of CAD. Every case was evaluated for fasting and postprandial blood sugar and fasting lipid profile. Body mass index (BMI) was also calculated. Coronary artery calcium was estimated in each patient by multi -slice spiral CT scan. Conventional angiography was also undertaken in 18 patients. Co-relation of coronary calcium with different age groups, sex, risk factors, electrocardiography and angiography was drawn.Results: Out of 51 cases scanned, 40 cases (78.4%) had detectable CAC. In 30 cases (58.8%), CAC score ranged from 1 to 100 (mild score); 6 cases (11.8%) had score between 101-400 (moderate score) while in 4 cases (7.8%) CAC score was more than 400 (severe score %). For detection of angiographically detectable disease, the sensitivity of multi-slice CT was 100% and the specificity was 33.3%.Conclusions: CAC is a valid measure of atherosclerotic plaque burden and is recommended as a screening tool for demonstrating significant atherosclerosis in susceptible subjects.
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