RESUMO
OBJECTIVE@#Bergenia ciliata (Haw.) Sternb. is used in the Indian traditional system of medicine to treat various ailments including rheumatism and to heal wounds. The objective of the present study was to perform a preclinical characterization of the B. ciliata-based botanical extract IIIM-160.@*METHODS@#IIIM-160 was chemically standardized and analyzed for heavy metal content, aflatoxins, pesticides and microbial load. The in vitro and in vivo efficacies were determined in suitable models of inflammation, arthritis and nociception. An acute oral toxicity study was performed in Swiss albino mice. A suitable oral formulation was developed and characterized.@*RESULTS@#Bergenin was found to be the major component (9.1% w/w) of IIIM-160. The botanical lead displayed inhibition of lipopolysaccharide-induced production of proinflammatory cytokines in THP-1 cells, with selectivity toward interleukin-6 (IL-6) and had an excellent safety-window. It showed anti-inflammatory, anti-arthritic and antinociceptive activity in animal models and was not toxic at oral doses up to 2 g/kg in Swiss-albino mice. The gastroretentive, sustained-release capsule formulation showed sustained-release of the bergenin over the period of 24 h, resulting in improved plasma-exposure of bergenin in Sprague-Dawley rats.@*CONCLUSION@#The dual-activity of IL-6 inhibition and antinociception marks the suitability of IIIM-160 for treating rheumatoid arthritis. This study will serve as the benchmark for further research on this botanical formulation.
RESUMO
Subarachnoid blockade can be used in all surgical procedures carried out on the infraumbilical region. This study was aimed to evaluate the clinical efficacy and safety of intrathecal fentanyl as an adjuvant to 0.75% isobaric ropivacaine on onset, duration, intensity, and recovery time of sensory and motor blockade of subarachnoid block for infra umbilical surgery. One hundred sixty adult consented patients of either gender with American Society of Anesthesiologist ASA I and II scheduled for infraumbilical surgery were randomized into two groups of 80 patients each to receive either intrathecal study solution of 4 mL of 0.75% ropivacaine with 0.4 mL of 0.9% sodium chloride [Group I-Ropivacaine Control Group RC] or fentanyl [20 micro g] [Group II-Ropivacaine with Fentanyl RF]. The end points were hemodynamic variability, onset of analgesia at T 10, maximum sensory analgesic level, time to complete motor blockade, duration of sensory and motor blockade and adequacy of surgical anesthesia. The post-spinal nausea and vomiting, shivering, pruritus, respiratory depression or any other side-effects were also assessed. At the end of study, data were systematically complied and analyzed for statistically significance. The intrathecal fentanyl has accelerated the onset time to achieve sensory blockade to T10 dermatome and motor blockade. Small dose of intrathecal fentanyl with ropivacaine has prolonged the duration of analgesia in the early post-operative period when compared with intrathecal ropivacaine alone. The intraoperative hemodynamic variability showed no statistically significant differences between groups. Intrathecal fentanyl as an adjuvant to 0.75% isobaric ropivacaine demonstrated better clinical profile as compared to ropivacaine alone