EXPERIMENTAL EVALUATION OF THE ANTI-ULCER ACTIVITY OF GRAPE (VITIS VINIFERA) SEED EXTRACT IN WISTAR ALBINO RATS AGAINST HYDROCHLORIC ACID – ETHANOL INDUCED ULCER MODEL

Background:Herbal products are finding increasing demand in the treatment of Peptic ulcer, on account of their better safety and efficacy.Objectives:To evaluate the anti-ulcer activity of ethanolic extract of seeds of Vitis Vinifera in Wistar albino rats.Methods:The ethanolic extract of Vitis Vinifera was investigated for its anti-ulcer activity in rats against HCl – Ethanol induced ulcer model. The antiulcer activity was assessed by determining and comparing gastric volume, pH, free and total acidity; ulcer number and its inhibition, ulcer severity and ulcer index.Results:A significant antiulcer activity was observed. The grape seed 100mg/kg group showed significant [p < 0.05] reduction in ulcer number 30.00 ± 3.23 as compared to the control. The grape seed 200mg/kg showed significant [p < 0.05] reduction in ulcer number 27.33 ± 2.97, free acidity 20.00 ± 2.26, and gastric lesion18.00 ± 2.96 as compared to the control.Conclusion:This present study indicates that Vitis vinifera seed extract has potential anti ulcer activity in the model tested. Keywords: Vitis vinifera, Anti-ulcer, Ethanol, Free acidity, Total acidit

Elevated levels of serum adenosine deaminase in type 2 diabetes mellitus patients

Background: Diabetes Mellitus (DM) is a metabolic disorder characterized by an absolute or relative deficiency of insulin and insulin resistance or both. Adenosine deaminase (ADA) is an enzyme, that catalyses the irreversible hydrolytic deamination of adenosine to uric acid. Since ADA activity is associated with T-lymphocyte activity and insulin resistance, in the present study, we measured serum ADA activity in type 2 Diabetes mellitus (T2DM) patients to evaluate the relationship between serum ADA activities with glycemic status.Methods: A total of 100 T2DM patients and controls were recruited for the study. Estimation of fasting plasma glucose (FPG), postprandial plasma glucose (PPG), HbA1c and fasting lipid profile was done. Serum ADA level was estimated by Colorimetric method. Statistical analysis of data was performed using the SPSS version 15.Results: ADA level was significantly higher (p<0.001) in patients with T2DM (45.5+4.6 U/L) than controls. A significant positive correlation was observed between serum ADA and HbA1c (r=0.585), FPG (r=0.495), PPG (0.387) and serum triglycerides (r=0.375) among subjects with T2DM but not among non-diabetic controls.Conclusions: In the present study, serum ADA activity in T2DM patients has been increased. High ADA activity reduces the glucose uptake into cells; therefore, insulin resistance is related to ADA activity

ALTERATIONS OF SERUM CALCIUM, PHOSPHORUS, MAGNESIUM, AND COPPER IN HYPERTHYROIDISM PATIENTS: A CASE–CONTROL STUDY: Mineral metabolism in Hyperthyroidism

Objective: The objective of the study was to estimate the levels of serum calcium, phosphorus, magnesium, and copper in hyperthyroid cases and to correlate each of the parameter with serum T3, T4, TSH, FT3, and FT4, respectively. Methods: The study was conducted on 60 newly confirmed hyperthyroid cases based on the thyroid profile and 60 euthyroid cases were recruited as controls. Blood samples were collected from all these subjects and estimation of serum T3, T4, TSH, FT3, FT4, calcium, phosphorus, and magnesium was done by autoanalyzer method. Serum copper was measured by modified spectrophotometric micro-method using guanidine hydrochloride and bathocuproine disulfonate disodium salt. The statistical analysis was done by paired test and Pearson’s correlation. Results: Study results in hyperthyroid cases show mean serum calcium and copper levels were significantly (p&lt;0.001) increased, serum phosphorus levels were significantly (p&lt;0.001) decreased when compared to euthyroid. However, there was no significant change in magnesium when compared with euthyroid controls (p=0.556). We also found a significant positive correlation among serum Ca versus T3, T4, FT3, and FT4. A negative correlation with serum Ca versus TSH as observed. We also found significant positive correlation between serum phosphorus with TSH and significant negative correlation of phosphorus with T3, T4, FT3, and FT4. No suggestive significant correlation was found between serum Mg with T3, T4, TSH, FT3, and FT4 and serum copper with serum T3, T4, TSH, FT3, and FT4. Conclusion: The present study has shown that metabolism of minerals is altered in hyperthyroid cases. Impaired metabolism of calcium, phosphorus, magnesium, and copper can lead to various metabolic disorders. Estimation of serum calcium, phosphorus, magnesium, and copper may be helpful in better management to prevent further complication and can be used as diagnostic or prognostic aid in patients with hyperthyroidism along with other biochemical parameters

EVALUATION OF THE ACUTE AND CHRONIC TOXICITY OF THE ETHANOLIC EXTRACT OF ABELMOSCHUS ESCULENTUS INSWISS ALBINO MICE

Objectives: This work aimed to evaluate the acute and chronic toxicity of the ethanolic extract of Abelmoschus esculentus, administered orally to Swiss albino mice. Methods: An dosage of 2000 mg/kg was administrated and toxicity studies were conducted following organization for economic cooperation and development guidelines of 425 and 407 respectively in Swiss albino mice. During the study, general signs of toxicity were monitored. The mice which are used in the toxicology study were sacrificed, and histological, hematological, and biochemical analyses were done. Results: No behavioral changes were observed in all mice subjected to the study. The extract did not bring about any deaths after 14 days for the acute toxicity study in all the doses and also 90 days at a very high dosage chronic toxicity study days. Although a significant variation was observed in hematocrit, granulocyte, lymphocyte, Alanine transaminase, total cholesterol levels, and blood glucose levels, the extract did not have any significant effect (p&lt;0.05) on the other biochemical and hematological parameters evaluated during the study. Conclusion: The result indicates that the oral administration of ethanolic extract of A. esculentus did not produce any significant toxic effect in the mice. Hence, the extract can be utilized safely for therapeutic use in pharmaceutical formulations

NEUROPROTECTIVE EFFECT OF ABELMOSCHUS ESCULENTUS ON CHRONIC STRESS AND EVALUATION OF LOSS OF MEMORY, ADAPTOGENIC EFFECT

Objective: Objective of this study was to determine if there was any neuroprotective effect of Abelmoschus esculentus L and its role in preventing memory loss during stressful conditions. Methods: The powder of A. esculentus L. pods was extracted with methanol and was used for evaluating anti-stress activity in experimental mice groups. The five experimental mice groups, namely, control, stress control, animals treated with extract followed by exposure to stress, animals exposed to stress followed by extract treatment, and mice groups treated with diazepam was evaluated. Biomarkers included were cortisol, brain homogenate acetylcholine esterase (AchE), superoxide dismutase (SOD), and malondialdehyde (MDA). In conjugation, working memory and reference memory were also studied in all animal groups by radial arm maze test, and results were recorded as the percentage of alteration score (PAS). Results: The concentration of stress indicators such as cortisol, MDA, and AchE activity was significantly elevated in stress control animals and associated with deficit working and reference memory. However, SOD was reduced in stressed mice and increased in treatment groups compared to the control mice. The anti-stress activity of A. esculentus L. pods was significantly correlated with higher working memory and reference memory with 1.33±0.51 and 1.17±0.40 PAS in pre-stress and post-stress treated mice groups, respectively. Conclusion: Methanolic extract of A. esculentus L. pods revealed the excellent anti-stress potential and also played a significant role in enhancing both working memory and reference memory in mice

Clinical Trials: The Role of Regulatory Agencies, Pharmacovigilance Laws, Guidelines, Risk Management, Patenting, and Publicizing Results

The research carried out to find a better treatment, improve healthcare, and benefit the current medical practice is termed clinical research. Clinical trial includes the pharmacodynamics (mechanisms of action of a new drug), pharmacokinetics (drug metabolism inside the body), therapeutics (efficacy of the drug), and adverse effects (safety of the drug) of the novel medical products. Clinical research is a process that involves human subjects and their biological specimens. The clinical trial is a meticulously planned protocol-based study of a drug/device to discover a new/better way to prevent, diagnose, and treat a disease/illness. Considering the involvement of both healthy and diseased people in clinical trials, the regulatory authorities have a significant role in the processes involving the conduction of clinical research and carefully evaluate their potential implications on humans. Because clinical trials are usually aimed at assessing the safety and efficacy of novel pharmaceutical compounds and medical devices, pharmacovigilance laws and risk management assume increased significance while conducting clinical research/trials. In this review, we attempt to discuss the regulatory authorities' roles in different geographical regions, including the United States of America, The European Union, and India. We also focus on the importance of pharmacovigilance laws and risk management during clinical trials

Clinical Trials: The Role of Regulatory Agencies, Pharmacovigilance Laws, Guidelines, Risk Management, Patenting, and Publicizing Results

The research carried out to find a better treatment, improve healthcare, and benefit the current medical practice is termed clinical research. Clinical trial includes the pharmacodynamics (mechanisms of action of a new drug), pharmacokinetics (drug metabolism inside the body), therapeutics (efficacy of the drug), and adverse effects (safety of the drug) of the novel medical products. Clinical research is a process that involves human subjects and their biological specimens. The clinical trial is a meticulously planned protocol-based study of a drug/device to discover a new/better way to prevent, diagnose, and treat a disease/illness. Considering the involvement of both healthy and diseased people in clinical trials, the regulatory authorities have a significant role in the processes involving the conduction of clinical research and carefully evaluate their potential implications on humans. Because clinical trials are usually aimed at assessing the safety and efficacy of novel pharmaceutical compounds and medical devices, pharmacovigilance laws and risk management assume increased significance while conducting clinical research/trials. In this review, we attempt to discuss the regulatory authorities' roles in different geographical regions, including the United States of America, The European Union, and India. We also focus on the importance of pharmacovigilance laws and risk management during clinical trials

Elevated levels of serum adenosine deaminase in type 2 diabetes mellitus patients

Background: Diabetes Mellitus (DM) is a metabolic disorder characterized by an absolute or relative deficiency of insulin and insulin resistance or both. Adenosine deaminase (ADA) is an enzyme, that catalyses the irreversible hydrolytic deamination of adenosine to uric acid. Since ADA activity is associated with T-lymphocyte activity and insulin resistance, in the present study, we measured serum ADA activity in type 2 Diabetes mellitus (T2DM) patients to evaluate the relationship between serum ADA activities with glycemic status.Methods: A total of 100 T2DM patients and controls were recruited for the study. Estimation of fasting plasma glucose (FPG), postprandial plasma glucose (PPG), HbA1c and fasting lipid profile was done. Serum ADA level was estimated by Colorimetric method. Statistical analysis of data was performed using the SPSS version 15.Results: ADA level was significantly higher (p&lt;0.001) in patients with T2DM (45.5+4.6 U/L) than controls. A significant positive correlation was observed between serum ADA and HbA1c (r=0.585), FPG (r=0.495), PPG (0.387) and serum triglycerides (r=0.375) among subjects with T2DM but not among non-diabetic controls.Conclusions: In the present study, serum ADA activity in T2DM patients has been increased. High ADA activity reduces the glucose uptake into cells; therefore, insulin resistance is related to ADA activity

Presepsin: A Novel and Potential Diagnostic Biomarker for Sepsis

Abstract Sepsis is a potential clinical condition which is a consequence of infectious disease or a severe inflammatory reaction secondary to infection or injury. Sepsis in Greek means putrefaction or decay, correlating well with the multiple organ failure and severe shock resulting in death of the patient suffering from severe sepsis. Clinical management of sepsis requires prompt laboratory diagnosis and formulation of effective patient management strategies that may include antimicrobial chemotherapy in case of sepsis induced by infectious microbe. Although many laboratory biomarkers are available for the diagnosis of sepsis, only few markers have proven to be beneficial in differentiating infectious disease sepsis and sepsis of non-infectious origin. Of the available markers only few have prognostic value. We in this review discuss the utility of a novel and emerging sepsis marker, the presepsin which has a better diagnostic and prognostic value, and has been effective in predicting the survival of the sepsis patients