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BACKGROUND: The polyherbal formulation (PHF) liberin, is known to exert anti-hyperglycemic effects in type 2 diabetes mellitus. Hence, it is important to study the safety profile of PHF in the current study through acute and chronic toxicity evaluation. OBJECTIVES: This research aims to assess the acute and sub-chronic toxicity of PHF in rats. MATERIALS AND METHODS: PHF was administered once orally (1000 mg/kg body weight), and the rats (male and female) were monitored for toxicity signs for a 14-day period. For a 28-day chronic toxicity study, rats were daily administered with PHF dose of 500 mg/kg and 1000 mg/kg body weight. Rats were followed up for mortality, weight changes, and other morbidities. Further haematological, biochemical, and histopathological changes were assessed. RESULTS: No death related to treatment or toxicity signs were recorded in the acute single-dose administration group. The results showed that the PHF was tolerated well up to a dose of 1000 mg/kg body weight. Even at the high dose of 1000 mg/kg body weight, sub-chronic tests did not show any significant difference between the dosed and normal groups. No significant changes were seen in the histopathological analysis of the liver, spleen, and kidney as well as haematological and biochemical parameters in acute, sub-chronic and satellite groups following the administration of PHF. CONCLUSION: The results confirmed that there was no adverse effect of this PHF at the maximum dose of 1000 mg/kg body weight in Wistar rats. Further, no adverse delayed effects related to PHF were observed in the satellite group. Therefore, this PHF appears safe for therapeutic purposes in the Ayurvedic medicinal system.
RESUMO
BACKGROUND: Ayurveda is a holistic system of medicine and describes a vast array of herbs and herbal mixtures that are been demonstrated to possess efficacy in research investigations. Guggulutikthaka gritha (GTG) is one such drug evaluated for its role in skin and bone diseases. OBJECTIVE: In the current study, the hypoglycemic, hypolipidemic, and anti-inflammatory effect of the drug GTG was studied with the scope to treat dyslipidemia and thereby reduce the risk of cardiovascular disease. MATERIALS AND METHOD: The animals (Wistar rats) were fed a high-fat diet and dyslipidemia was induced. The control group was provided with a normal chow diet and had free access to water. The treatment with the drug GTG was given for 21 days after confirming dyslipidemia. The blood glucose was measured immediately using a glucometer. The serum was analyzed for lipid profile and Vascular Cell Adhesion Molecule - 1(VCAM 1) by ELISA method before and after treatment. The histopathology of the heart and liver was also performed. RESULTS: The abnormal change in lipid profile, blood glucose, and inflammatory marker along with the accumulation of intracellular fats in the arteries of the heart and liver confirmed dyslipidemia. A significant reduction in serum lipid profile (p < 0.05), blood glucose (p < 0.05), and VCAM 1 (p < 0.05) was noted after the treatment with significant histopathological changes in arteries of the heart and liver. CONCLUSION: The study provides scientific validation on the drug GTG being effective in hyperglycemia, hyperlipidemia, and inflammation in dyslipidemia.
RESUMO
BACKGROUND: The mortality and morbidity rate of diabetes patients is increasing worldwide which requires an ideal treatment to prevent the disease worsening. Traditional medicine is gaining more attention in diabetes due to its efficacy and safety. We, therefore performed a systematic review study of clinical trials to assess the comparative effect of polyherbal formulations in type 2 Diabetes mellitus. OBJECTIVES: To find the effectiveness of polyherbal formulations in blood sugar and lipid level for type 2 Diabetes mellitus. MATERIAL AND METHODS: PubMed, Scopus and CINAHL databases for clinical trials investigating the effect of polyherbal formulations in Type 2 Diabetes mellitus patients were searched. Meta-analysis of eligible trials was conducted employing Revman 5.2 software. RESULTS: Fourteen randomized controlled trials were found eligible for meta-analysis. Meta-analysis of findings showed a significant effect of polyherbal formulations on blood sugar level compared to control group. The estimated standard mean changes at 95% confidence interval, following polyherbal formulations treatment were -0.59, (-0.91 to - 0.27) mg/dL; for fasting blood sugar(p < 0.001), -0.69, (-1.18 to -0.21) mg/dL; for postprandial blood sugar (p = 0.005) and -0.46, (-0.88 to -0.04) gm%; for glycated haemoglobin (p = 0.03). The reduction in postprandial sugar and glycated haemoglobin was statistically significant with polyherbal formulations compared to metformin treatment but not for fasting sugar. Similarly in lipid profile the reduction for total cholesterol and triglycerides was statistically significant with polyherbal formulations compared to control group but was not significant for HDL and LDL whereas in other group of polyherbal formulations and metformin only HDL was favouring polyherbal formulations. CONCLUSION: Polyherbal formulations occurred to be effective in lowering blood sugar level in Type 2 diabetes but their further efficacy in managing diabetes needs to be validated. Therefore, a qualitative, long term, randomized placebo-controlled trials of adequate sample size are necessary to determine the efficacy of polyherbal formulation in managing diabetes.
RESUMO
BACKGROUND: Yuva Spandana (YS) is a youth mental health promotion program implemented across all 30 districts of Karnataka. Yuva Parivarthakas (YPs - youth change agents) are trained to provide mental health promotion services to any "youth with issues" through Yuva Spandana Kendras (guidance centers) situated within district stadiums across Karnataka. Aim of the study was to evaluate the change (comparing before and after training) in different learning domains (cognitive - knowledge, affective - attitude, and psychomotor - practice) among trainees (YPs) attending YS training. METHODS: Quasiexperimental study design was utilized for this study. A semistructured interview schedule was developed and used before and after the training. Data were analyzed by descriptive statistics. The difference in change of mean score was assessed using the paired t-test. The shift in the proportion of trainees post-training in the three domains was assessed using McNemar's test. RESULTS: The mean (±SD) age of trainees was 27.5 ± 3.3 years. Majority of them were males (63.8%), had completed bachelor's degree (53.4%), and were residing in rural Karnataka (77.7%). The knowledge and attitude scores significantly improved (P < 0.001) post-training, without significant improvement in practical skills. CONCLUSION: It is recommended that future training programs need to be focused on creating opportunities to YPs in order to increase their practical skills to work with youth having issues.
