ABSTRACT
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.
ABSTRACT
Background: Most patients with noncommunicable diseases (NCDs) can be managed appropriately at the primary care level, using a simplified standard protocol supported by low-cost drugs. The primary care response to common NCDs is often unstructured and inadequate in low- and middle-income countries. This study assessed the feasibility of integration of NCD prevention and control within the primary health-care system of India. Methods: This study was done among 12 subcentres, 2 primary health centres (PHCs) and one subdistrict hospital in a block in north India. All 28 multipurpose health workers of these subcentres underwent 3-day training for delivering the package of NCD interventions as a part of their routine functioning. A time–motion study was conducted before and after this, to assess the workload on a sample of the workers with and without the NCD work. Screening for risk assessment was done at domiciliary level as well as at health-facility level (opportunistic screening), and the cost was estimated based on standard costing procedures. Individuals who screened positive were investigated with electrocardiography and fasting blood sugar. PHCs were strengthened with provision of essential medicines and technologies. Results: After training, 6% of the time of workers (n = 7) was spent in the NCDrelated activities, and introduction of NCD activities did not impact the coverage of other major national health programmes. Loss during referral of “at-risk” subjects (37.5% from home to subcentre and 33% from subcentre to PHC) resulted in screening efficiency being lowest at domiciliary level (1.3 cases of NCDs identified per 1000 screened). In comparison to domiciliary screening (`21 830.6; US$ 363.8 per case identified), opportunistic screening at subdistrict level (`794.6; US$ 13.2) was 27.5 times and opportunistic screening at PHC (`1457.5; US$ 24.3) was 15.0 times lower. There was significant utilization of NCD services provided at PHCs, including counselling. Conclusion: Opportunistic screening appears to be feasible and a cost-effective strategy for risk screening. It is possible to integrate NCD prevention and control into primary health care in India.