A 45-DAY RANDOMIZED, OPEN-LABEL, COMPARATOR STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ZINCOVIT TABLETS WITH GRAPE SEED EXTRACT (NUTRITIONAL FOOD SUPPLEMENT) IN PATIENTS WITH TYPE 2 DIABETES MELLITUS

ABSTRACTObjective: To evaluate the efficacy of Zincovit (ZVT) tablets with grape seed extract (GSE) in patients with Type 2 diabetes mellitus by testing thehypothesis of a greater reduction in plasma glucose levels (fasting blood sugar [FBS] and post-prandial blood sugar [PPBS]) from baseline and after45 days of therapy as compared to standard comparator.Methods: This was a randomized, open-label, comparative (2-arm), prospective 45 days study. Treatment consisted of 2 arms: Antidiabetic drugplus non-pharmacological measure alone or ZVT tablets with GSE plus non-pharmacological measures. A total of 30 patients (15 in each arm) wereincluded in the study.Results: ZVT tablet did not alter the FBS, PPBS, and HbA1c level in diabetic patients compared to diabetic patients treated with placebo. No changeswere seen in any of the safety parameters when given for 45 days.Conclusion: ZVT tablets do not possess antidiabetic activity in spite of good safety profile in our study design. This could be due to several limitationsof the study such as inadequate sample size, short duration of the study, and wrong selection of the patients. A long-term, double-blind, placebocontrolled study in a large sample of population measuring glycemic parameters, and cardiovascular outcomes could give a clear picture of the antidiabeticeffectof ZVT with GSE tablets.Keywords: Diabetes mellitus, Zincovit tablets, Grape seed extract, Antioxidant, Safety parameters

Clinical and radiological profile of patients with cerebral venous and sinus thrombosis in a tertiary care hospital

Background: Cerebral venous and sinus thrombosis (CVT) is one of the common causes of stroke in young people. It is a relatively uncommon neurologic disorder that is potentially reversible with prompt diagnosis and appropriate medical care. The purpose of this study is to identify the clinical and radiological features aiding diagnosis of cortical vein thrombosisMethods: A cross-sectional study was conducted from November 2015 to May 2017 in tertiary care centre in Manipal after institutional ethical clearance. A total of 46 patients diagnosed with CVT were included in the study. Clinical symptoms and signs at admission and radiological features were documented.Results: A total of 46 subjects were included. Males (53.3%) were more affected than females (46.7%), mostly in the 3rd decade. The most common risk factors were polycythaemia (31.1%) and oral contraceptive pill intake (17.7%). Headache was the most common symptom followed by paralysis and seizures. Multiple sinuses were involved in two-thirds of the patients. Superior sagital sinus thrombosis was the most common sinus involved followed by transverse sinus thrombosisConclusions: The most common clinical feature is headache followed by paresis and seizures. Superior saggital sinus thrombosis is more common than transverse and sigmoid sinus thrombosis in Indian population. Normal CT scan of brain doesn’t rule out cerebral venous sinus thrombosis

Running Head: Reading Comprehension: Reviving the Sentence Verification Technique

Reading success is largely determined by reading comprehension. Thus accurate assessment of reading comprehension is necessary to identify those who require remediation and to plan future instructions in classrooms. Sentence verification technique (SVT) is one of the methods of assessing comprehension and can function as a diagnostic tool in reading assessment. The aim of the current study was to determine whether the SVT could detect gender and grade differences in reading comprehension. The study targeted 1091 elementary grade students comprising both boys and girls who were assessed using the SVT. The students read two text passages selected according to their grade level and responded to four sentence types - original, paraphrase, meaning change and distracter sentences. Independent sample t test highlighted that girls were significantly better than boys with regard to reading comprehension ability. One way analysis of variance to analyse grade differences indicated that there were significant improvements in reading comprehension ability with higher grades, thus highlighting the sensitivity of SVTs in detecting developmental changes in reading comprehension. The findings of this study emphasize the diagnostic potential of the SVTs with regard to identifying children with reading comprehension difficulties which in turn would help in planning their remediation. These SVTs can be easily developed by school teachers and other non-psychometricians for the purpoe of identifying students requiring assistance. The paper will discuss the finding, purpose and uses of SVT along with its classroom implications

A rare case of neomercazole induced hepatitis

Neomercazole is one of the most commonly used drugs to treat hyperthyroidism. Common side effects include rash, hair loss and agranulocytosis. Hepatotoxicity is a common side effect of Propylthiouracil, the other major antithyroid drug, but it has been rarely described as a side effect of neomercazole. Here, a patient presents with hepatitis 6 months after starting neomercazole therapy for graves disease. Diagnosis is based on excluding other causes of hepatitis, and treatment involves removing the offending drug. This is followed by normalization of liver function. Rechallenging should not be done as it can lead to recurrence of symptoms

C-reactive protein and coronary heart disease - risk marker or risk factor?

Cardiovascular diseases are gaining a dubious distinction of becoming the leading cause of death. Thus, the search for new risk markers and risk factors of cardiovascular disease continue, in an attempt to predict the risk of cardiovascular events with greater precision. Of all the risk markers available, high sensitivity C-reactive Protein (hsCRP) is considered to be the most robust tool with test characteristics desirable and conducive for clinical use. Pharmacological intervention trials were successful in reducing hsCRP in individuals with elevated levels, following which its status as a therapeutic target has taken a big leap. Numerous pharmacologic and non-pharmacologic interventions are presently being investigated for their efficacy in reducing this inflammatory marker. This review discusses the stability of hsCRP, factors affecting the concentration, independent predictive ability as compared to the traditional risk factors and its role in atherogenesis

A study of right ventricular infarction in inferior wall myocardial infarction

Background: Right ventricular infarction (RVI) is frequently associated with inferior wall myocardial infarction (MI). Methods: This study was designed to identify the burden of RVI in patients presenting with inferior wall MI (n=50) by right precordial electrocardiogram (ECG) and comparing it with echocardiography (ECHO). Results: Their mean age was (54.5 ± 11.9 years); there were 42 males. ST elevation of greater than 1 mm in right precordial leads (RPL) suggestive of RVI was evident in 16 (32%) cases. Among the RPL (V3R - V6R) V4R and V5R showed sensitivity of 87.5%. The 12-lead ECG finding of ST-elevation greater than 1 mm in lead III and lead III/II greater than 1, had poor sensitivity (75%), specificity (88.2%) compared to ST- elevation of greater than 1 mm in any of the RPL (100%). Both the echocardiography criteria, namely right ventricular end-diastolic dimension (RVEDD) greater than 25 mm (92.3%) and the ratio of RVEDD to left ventricular end-diastolic dimension (RVEDD/LVEDD) greater than 0.7 (90%) indicating right ventricle (RV) dilatation was observed significantly more frequently in RVI group. Conclusions: RVI occurs in more than one-third of patients with acute inferior wall MI. All the patients with inferior wall MI should have RPL recorded as early as possible for evidence of RVI, of which V4R, V5R have the highest sensitivity

CLINICAL AND BIOCHEMICAL PROFILE OF STEROID-INDUCED DIABETES

ABSTRACTObjective: To study the clinical and biochemical profile of patients who develop steroid-induced diabetes (SID) and its predisposing factors.Methods: Non-diabetic patients aged ≥18 years started on steroids were considered eligible for the study. In every case after detailed examination,fasting plasma glucose (FPG), post-prandial plasma glucose (PPG), glycated hemoglobin, fasting insulin were measured prior to starting steroids andwas repeated in 1 week (day 3/4) after starting steroid according to standard guidelines. FPG and PPG were repeated periodically during follow-upof the patients. The utility of Indian diabetic risk score (IDRS) score in predicting the risk for SID was also assessed.stResult: Steroid-induced diabetes was found to be more in females than in males. IDRS is not useful in predicting the risk factors of SID. 97% of patientshad an elevation of post-prandial sugars with or without fasting hyperglycemia, but only 3% of patients had isolated elevation of fasting blood sugar.84% of patients developed SID during the 1 week of therapy. 33% of the cases SID persisted even after 1 month of stopping steroids and on a minimaldosage of steroids.stConclusion: Unlike type 2 diabetes, there were no significant risk factors such as age, family history of diabetes to develop SID and IDRS may not be asensitive tool for predicting risk factors of SID. Monitoring of post-prandial sugars as compared to fasting sugars is essential for the screening of SID.Cumulative dose of steroid may not be important to precipitate steroid diabetes.Keywords: Glucocorticoids, Diabetes, Post-prandial glucose, Indian Diabetic Risk Score

Highly active antiretroviral therapy induced adverse drug reactions in Indian human immunodeficiency virus positive patients

Objective: To assess the incidence, severity pattern, causality, predictability and preventability of adverse drug reactions (ADRs) and to identify risk factors for adverse drug reactions in highly active antiretroviral therapy. Methods: Enrolled patients were intensively monitored for ADRs to highly active antiretroviral therapy. Predictability was assessed based on history of previous exposure to the drug or literature incidence of ADRs. Preventability was assessed using Schumock and Thornton criteria and severity was assessed using modified Hartwig and Siegel scale. Multivariate logistic regressions were used to identify the risk factors for ADRs. Results: Monitoring of 130 retropositive patients by active pharmacovigilance identified 74 ADRs from 57 patients. Anemia and hepatotoxicity were the most commonly observed ADRs. The organ system commonly affected by ADR was red blood cell (21.4%).The ADRs were moderate in 77% of cases. Type A reactions (77%) were more common. A total of 10.8% ADRs were definitely preventable. The incidence rate of ADRs (65.9%) was highest with Zidovudine + Lamivudine + Nevirapine combination. A total of 84% interruptions to highly active antiretroviral therapy were due to toxicity. CD4 less than 200 cells/ìl, female gender and tuberculosis were observed as risk factors for ADRs. Conclusion: Incidence of ADRs in intensively monitored patients was found to be 43.8%. Anemia in HIV patients is an influential risk factor for occurrence of ADRs. With the increasing access to antiretroviral in India, clinicians must focus on early detection and prevention of ADRs to highly active antiretroviral therapy.Objetivo: Evaluar la incidencia, gravedad, causalidad y preventabilidad de las reacciones adversas medicamentosas (RAM) e identificar los factores de riesgo de esas RAM en terapias de antiretrovirales altamente activos. Metodos: Se monitorizo intensamente a los pacientes incluidos a la busqueda de RAM. La predecibilidad se evaluo con base en la historia de exposiciones previas al medicamento o a la incidencia de RAM en la literatura. La preventabilidad se valoro usando los criterios de Schumock y Thornton y la gravedad se evaluo utilizando la escala modificada de Hartwig y Siegel. Se utilizaron regresiones logisticas multivariadas para identificar los factores de riesgo de RAM. Resultados: La monitorizacion retrospectiva de 130 pacientes mediante farmacovigilancia activa identifico 74 RAM de 57 pacientes. Anemia y hepatotoxicidad fueron las RAM mas comunmente observadas. El sistema comunmente afectado por las RAM fueron las celulas rojas sanguineas (21,4%). Las RAM fueron moderadas en el 77% de los casos. Las reacciones tipo A fueron las mas comunes. Un total del 10,8% de RAM fueron definitivamente prevenibles. La incidencia de RAM mas alta fue con la combinacion Zidovudina + Lamivudina + Nevirapina. Un 84% de las interrupciones de terapias antiretrovirales altamente activas fue debido a la toxicidad. Se observaron como factores de riesgo de RAM un CD4 en menos de 200 cel, el genero femenino y la tuberculosis. Conclusion: La incidencia de RAM en pacientes intensivamente monitorizados fue del 43,8%. La anemia en pacientes con VIH es u7n factor d e riesgo de influencia en la aparicion de RAM. Con el creciente uso de antiretrovirales en India, los clinicos deben centrar la atencion en la deteccion temprana y la prevencion de RAM de terapias antiretrovirales altamente activos