Regulatory safety pharmacology and toxicity assessments of a standardized stem extract of Cassia occidentalis Linn. in rodents.

Cassia occidentalis Linn (CO) is an annual/perennial plant having traditional uses in the treatments of ringworm, gastrointestinal ailments and piles, bone fracture, and wound healing. Previously, we confirmed the medicinal use of the stem extract (ethanolic) of CO (henceforth CSE) in fracture healing at 250 mg/kg dose in rats and described an osteogenic mode of action of four phytochemicals present in CSE. Here we studied CSE's preclinical safety and toxicity. CSE prepared as per regulations of Current Good Manufacturing Practice for human pharmaceuticals/phytopharmaceuticals and all studies were performed in rodents in a GLP-accredited facility. In acute dose toxicity as per New Drug and Clinical Trial Rules, 2019 (prior name schedule Y), in rats and mice and ten-day dose range-finding study in rats, CSE showed no mortality and no gross abnormality at 2500 mg/kg dose. Safety Pharmacology showed no adverse effect on central nervous system, cardiovascular system, and respiratory system at 2500 mg/kg dose. CSE was not mutagenic in the Ames test and did not cause clastogenicity assessed by in vivo bone marrow genotoxicity assay. By a sub chronic (90 days) repeated dose (as per OECD, 408 guideline) study in rats, the no-observed-adverse-effect-level was found to be 2500 mg/kg assessed by clinico-biochemistry and all organs histopathology. We conclude that CSE is safe up to 10X the dose required for its osteogenic effect.

Cross-sectional osteoporotic risk prediction with the FRAX without BMD in male and female patients attending OPD in a community health center of Bihar.

Background: Bone health is an important requirement for healthy aging. Osteoporosis is an important cause of both mortality and morbidity among older adults. If we can predict the risk of future osteoporosis by cost-effective methods, we can prevent it up to certain level and plan intervention accordingly. That's why the present study aims to estimate the likelihood of osteoporosis in patients attending the outpatient department (OPD) in a selected community health center (CHC). Methods: A cross-sectional study was conducted in a CNC in Siwan, Bihar, India. An equal number of male and female patients were recruited by quota sampling. A semi-structured proforma was prepared for data collection using the Fracture Risk Assessment (FRAX) tool without performing a bone mineral density (BMD) test in order to assess major osteoporotic fractures and risk for hip fractures with other requisite information. Results: The collected data were organized using Microsoft Excel and analyzed using the statistical software SPSS Statistics 20. As data were gleaned and put under different categories, a statistical analysis based on the Chi-square test was carried out, and an ROC (receiver operating characteristic) curve was also drawn for statistical inference of the data gathered. The main findings of our analyses include the following: Approximately 15% males and 30% females in the study sample had a higher risk of osteoporosis and about 9% males and 36% females had a higher risk of hip fracture. Overall, the findings showed a statistically significant association (p < 0.05) between the gender of the participants and the FRAX risk scores for osteoporosis and hip fracture. Conclusion: Previously osteoporosis was thought of as a disease that affected only women; nevertheless, emerging findings show that osteoporosis is not unusual in men. The FRAX tool can be used as a screening tool before going for a BMD test.