Surgically Induced Demyelination in Rat Sciatic Nerve.

Demyelination is a common sign of peripheral nerve injuries (PNIs) caused by damage to the myelin sheath surrounding axons in the sciatic nerve. There are not many methods to induce demyelination in the peripheral nervous system (PNS) using animal models. This study describes a surgical approach using a single partial sciatic nerve suture to induce demyelination in young male Sprague Dawley (SD) rats.

Efficacy of Standardized Extract of (Bacognize®) on Cognitive Functions of Medical Students: A Six-Week, Randomized Placebo-Controlled Trial.

. , popularly known as Brahmi, has been traditionally used in Ayurveda since ages for its memory enhancing properties. However, data on placebo-controlled trial of on intellectual sample is scarce.

Evaluation of a new computerized psychometric test battery: Effects of zolpidem and caffeine.

Objective: To evaluate the effects of centrally active drugs using a new indigenously developed automated psychometric test system and compare the results with that obtained using pencil- and paper-based techniques.

Materials And Methods: The tests were standardized in 24 healthy participants. Reproducibility of the test procedure was evaluated by performing the tests by a single experimenter on two occasions (interday reproducibility).

A computerized stroop test for the evaluation of psychotropic drugs in healthy participants.

Background: The Stroop paradigm evaluates susceptibility to interference and is sensitive to dysfunction in frontal lobes and drug effects. The aim of the present study was to establish a simple and reliable computerized version of Stroop color-word test, which can be used for screening of various psychotropic drugs.

Materials And Methods: The standardized method was followed in all cases, by recording the reaction time (RT) in msec in 24 healthy participants using computerized version of Stroop color-word test.

Human experimental pain models: A review of standardized methods in drug development.

Human experimental pain models are essential in understanding the pain mechanisms and appear to be ideally suited to test analgesic compounds. The challenge that confronts both the clinician and the scientist is to match specific treatments to different pain-generating mechanisms and hence reach a pain treatment tailored to each individual patient. Experimental pain models offer the possibility to explore the pain system under controlled settings.

The effect of L-arginine on arterial stiffness and oxidative stress in chronic kidney disease.

Chronic kidney disease (CKD) is a growing problem worldwide. The disproportionate increase in the burden of cardiovascular disease in patients with CKD may be significantly contributed by nontraditional risk factors. Increased arterial stiffness has been recognized as an important player in contributing to this morbidity and mortality.

A simple cold pressure technique for the evaluation of analgesic drugs in healthy subjects.

Aim: An experimental pain model which is sensitive and reproducible would be a useful pharmacological tool both for existing and new drugs. The aim of the present study was to establish a simple and reliable method of producing experimental pain which can be used for screening of analgesic agents.

Materials And Methods: The method was standardized by recording pain threshold and pain tolerance values in 24 healthy volunteers.

Effect of beta-1-blocker, nebivolol, on central aortic pressure and arterial stiffness in patients with essential hypertension.

Introduction: Blood pressure (BP) reduction is the major determinant of benefit provided by antihypertensive treatment. Although different drugs reduce peripheral BP to some extent, there may be a significant difference in their effect on central BP reduction. It has been shown that beta-blockers are efficient in reducing peripheral, but not central BP.

A simple thermal pain model for the evaluation of analgesic activity in healthy subjects.

Objective: Assessment of the analgesic effect of an agent in an experimental pain model permits a level of control not possible in a clinical pain setting and is an ideal approach for evaluation of analgesic drugs. The aim of the present study was to establish a simple and reliable method of producing experimental pain, which can be used for screening of various analgesic agents.

Materials And Methods: The standardized method was followed in all cases, by recording thermal pain threshold in seconds in 24 healthy volunteers using hot air source at two different speeds, which is equipped in an acrylic-made chamber adjustable to three different levels.

Non-invasive measurement of aortic pressure in patients: Comparing pulse wave analysis and applanation tonometry.

Objective: The aim of the present study was to validate and compare novel methods to determine aortic blood pressure non-invasively based on Oscillometric Pulse Wave Velocity (PWV) measurement using four limb-cuff pressure waveforms and two lead Electrocardiogram (ECG) with a validated tonometric pulse wave analysis system in patients.

Materials And Methods: After receiving the consent, in 49 patients with hypertension, coronary artery disease, diabetes mellitus, PWV, and central blood pressures were recorded in a randomised manner using both the oscillometric and tonometric devices. All recordings were performed 10 minutes after the patient lying comfortably in a noise-free temperature-controlled room.

Development of a simple radiant heat induced experimental pain model for evaluation of analgesics in normal healthy human volunteers.

Objective: Human experimental pain models help to understand the mechanism of the painful conditions and can also be adopted to test analgesic efficacy of drugs. In early phases, the clinical development of new analgesics is hindered due to the lack of reliable tests for the experimental pain models. In the present study, we have developed and validated a simple radiant heat pain model which can be used for future screening of various analgesic agents.

A simple contact heat experimental pain model for evaluation of analgesic agents in healthy volunteers.

Background: Human experimental pain models help to understand the mechanism of the underlying clinical pain conditions and can be adopted to test analgesic efficacy of drugs used in the management of pain. In early phases, the clinical development of new analgesic agents is severely hindered due to lack of reliable sensitive tests for the experimental pain models.

Objective: The aim of the present study was to standardize and validate a simple contact heat pain model that can be used for future screening of various analgesic agents.

Pharmacodynamic interaction study of Allium sativum (garlic) with cilostazol in patients with type II diabetes mellitus.

Aim: Garlic is available as an over-the-counter herbal supplement and is known to have antiplatelet properties. Because of scarcity of clinical data regarding the safety of concomitant use of garlic supplements and anticoagulants, we tried to evaluate the effects of coadministration of single and multiple doses of garlic and cilostazol on platelet aggregation.

Materials And Methods: The study was a randomized, open label, placebo-controlled, crossover study of type II diabetic patients, where 14 patients were enrolled and 10 completed the study.

Antitumor activity of NRC-AN-019 in a pre-clinical breast cancer model.

Breast cancer is the second most frequently diagnosed tumor in women. Overexpression of human epidermal growth factor receptors (EGFRs) represents a biological subclass of breast cancer with distinct molecular alterations, clinical behavior and response to systemic therapy. In this study, we describe a novel compound (NRC-AN-019), which has better antitumor activity than Lapatinib.

Oxidative stress in hemodialysis patients receiving intravenous iron therapy and the role of N-acetylcysteine in preventing oxidative stress.

To determine the contribution of injectable iron administered to hemodialysis (HD) patients in causing oxidative stress and the beneficial effect of N-acetylcysteine (NAC) in reducing it, we studied in a prospective, double blinded, randomized controlled, cross over trial 14 adult HD patients who were randomized into two groups; one group received NAC in a dose of 600 mgs twice daily for 10 days prior to intravenous iron therapy and the other group received placebo. Both the groups were subjected to intravenous iron therapy, 100 mg of iron sucrose in 100 mL of normal saline given over a period of one hour. Blood samples for the markers of oxidative stress were taken before and after iron therapy.

Pharmacokinetic analysis and phase 1 study of MRX-1024 in patients treated with radiation therapy with or without cisplatinum for head and neck cancer.

Purpose: A previous study reported radiation protection from mucosal injury with D-methionine (D-met) in preclinical evaluation; therefore, the pharmacokinetics, safety, and utility of D-met were evaluated clinically.

Experimental Design: The pharmacokinetics of D-met following oral administration of a bioavailable formulation (MRX-1024) was evaluated in normal volunteers. Subsequently, 25 patients were enrolled on a phase 1 study of MRX-1024 concurrent with radiation therapy (RT) with or without weekly cisplatinum.

Phase 0 - Microdosing strategy in clinical trials.

Drug development is an activity that is long, complex and expensive. In 2004, attrition in the drug development paradigm prompted the US Food and Drug Administration (FDA) to introduce its 'Critical Path' document, which highlighted the serious discordance between major scientific advances and limited drug development process. One issue addressed was that of microdosing.

Effect of NCB-02, atorvastatin and placebo on endothelial function, oxidative stress and inflammatory markers in patients with type 2 diabetes mellitus: a randomized, parallel-group, placebo-controlled, 8-week study.

Background And Objective: Hyperglycaemia leads to increased oxidative stress resulting in endothelial dysfunction. ACE inhibitors, antioxidants and HMG-CoA reductase inhibitors (statins) have been shown to improve endothelial function. The aim of this study was to compare the effects of NCB-02 (a standardized preparation of curcuminoids), atorvastatin and placebo on endothelial function and its biomarkers in patients with type 2 diabetes mellitus.

Randomized, single-blind, crossover comparison of two rupatadine tablet formulations on histamine-induced cutaneous response in healthy adult volunteers.

Background: Rupatadine is a histamine receptor type 1 antagonist that has been used to treat allergic rhinitis and urticaria.

Objective: The aim of this study was to compare the effect of 2 rupatadine tablet formulations on the inhibition of histamine-induced wheal-and-flare cutaneous responses.

Methods: In this single-blind, single oral dose, crossover study, healthy male volunteers were randomized to receive 10 mg of either a rupatadine reference or test formulation after an overnight fast.

Influence of piperine on the pharmacokinetics of nevirapine under fasting conditions: a randomised, crossover, placebo-controlled study.

Background: Nevirapine is a potent non-nucleoside inhibitor of HIV-1 reverse transcriptase and is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. Piperine (1-piperoylpiperidine) is an alkaloid and the main pungency principle in both black and long pepper. There are indications that piperine inhibits, rather than stimulates, drug metabolism in most cases, thus increasing the bioavailability and effect of some drugs.

Safety, immunogenicity, and antibody persistence of a new meningococcal group A conjugate vaccine in healthy Indian adults.

We performed a double-blind, randomized, controlled phase I study to assess safety, immunogenicity, and antibody persistence of the new meningococcal group A conjugate vaccine (PsA-TT) in healthy volunteers aged 18-35 years. Of the 74 male subjects enrolled, 24 received the PsA-TT vaccine (Group 1), 25 received the Meningococcal Polysaccharide Vaccine A+C, Pasteur, Lyon, France (Group 2), and 25 received the Tetanus Toxoid Vaccine Adsorbed, SIIL, Pune India (Group 3). No immediate reactions were observed.

Randomised, Double-Blind, Parallel, Placebo-Controlled Study of Oral Glucosamine, Methylsulfonylmethane and their Combination in Osteoarthritis.

Objective: Glucosamine, classified as a slow-acting drug in osteoarthritis (SADOA), is an efficacious chondroprotective agent. Methylsulfonylmethane (MSM), the isoxidised form of dimethyl-sulfoxide (DSMO), is an effective natural analgesic and anti-inflammatory agent. The aim of this study was to compare the efficacy and safety of oral glucosamine (Glu), methylsulfonylmethane (MSM), their combination and placebo in osteoarthritis of the knee.

Efficacy and tolerability of trandolapril in mild to moderate hypertension--a double blind comparative clinical trial with enalapril in Indian population.

Several large scale clinical trials have demonstrated that angiotensin converting enzyme inhibitors offer cardiovascular and renal protection independent of their effects on systolic BP. Trandolapril is a new angiotensin converting enzyme inhibitor approved for the treatment of hypertension. The potential advantages of this drug are long duration of action and better tolerability.