ABSTRACT
Background and aim: Dengue a worldwide concern for public health has no effective vaccine or drug available for its prevention or treatment. There are billions of people who are at risk of contracting the dengue virus (DENV) infections with only anti-mosquito strategies to combat this disease. Based on the reports, particularly in vitro studies and small animal studies showing anti-viral activity of aqueous extract of Cocculus hirsutus (AQCH), studies were conducted on AQCH tablets as a potential for the treatment of dengue and COVID-19 infections. The current study was part of the research on AQCH tablet formulation and was aimed to evaluate safety and pharmacokinetics in healthy human subjects. Materials and methods: Sixty healthy adult human subjects were divided into 5 groups (cohorts: I to V; n = 12 per cohort) and randomized in the ratio of 3:1 to receive active treatment or placebo in a blinded manner. Five doses 100 mg, 200 mg, 400 mg, 600 mg and 800 mg tablets were administered three times daily at an interval of 8 h for days 01-09 under fasting conditions and a single dose in morning on day 10. Safety assessment was based on monitoring the occurrence, pattern, intensity, and severity of adverse events during study period. Blood samples were collected for measurement of the bio-active marker Sinococuline concentrations by a validated LC-MS/MS method followed by pharmacokinetic evaluation. Results and conclusion: The test formulation was well tolerated in all cohorts. Sinococuline peak plasma concentration (Cmax) and total exposure of plasma concentration (AUC) demonstrated linearity up to 600 mg and saturation kinetics at 800 mg dose. There was no difference observed in elimination half-life for all the cohorts, suggesting absence of saturation in rate of elimination. Dose accumulation was observed and steady state was achieved within 3 days. The information on human pharmacokinetics of AQCH tablets would assist in further dose optimization with defined pharmacokinetic-pharmacodynamic relationship.
ABSTRACT
How to cite this article: Kumar A, Sabharwal P, Gupta P, Singh VK, Rao BK. Reply to Letter to the Editor: A Fatal Case of Acute Disseminated Encephalomyelitis-A Diagnosis to Ponder in Pandemic. Indian J Crit Care Med 2022;26(9):1062.
ABSTRACT
A 40-year-old woman known hypertensive presented with progressive ascending paralysis. MRI T2W and FLAIR screening of the brain demonstrated swelling with altered signal in the visual cervical cord, medulla, and another juxtacortical lesion in the right temporal lobe with possibility of a demyelinating etiology. CSF testing did not identify a direct cerebral infection. High-dose steroids followed by a course of IVIG was administered but with no significant response. In these pandemic times, the patients who present with altered mentation and polyfocal neurological deficits and background history of recent COVID-19 infection or recipient of SARS-CoV-2 vaccine the diagnosis of acute disseminated encephalomyelitis (ADEM) should be considered likely. How to cite this article: Kumar A, Sabharwal P, Gupta P, Singh VK, Rao BK. A Fatal Case of Acute Disseminated Encephalomyelitis: A Diagnosis to Ponder in Pandemic. Indian J Crit Care Med 2022;26(4):518-520.