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   Table of Contents - Current issue
Coverpage
January-June 2017
Volume 8 | Issue 1
Page Nos. 1-29

Online since Wednesday, October 18, 2017

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REVIEW ARTICLE  

Mass spectrometry-based metabolomics in biomarker-assisted drug discovery and oxidative stress research p. 1
A Kiran Kumar, Sagarika Devi, V Sivaram
DOI:10.4103/ddt.DDT_2_16  
Biomarker-assisted drug discovery is a major step in identification of drug efficacy and disease proliferation of both communicable and noncommunicable diseases. Biomarker-assisted drug discovery using metabolomics approach is now a reliable “path of opportunity” in drug discovery, as it offers precise insight into the efficacy of tested drug in the biological setup. With the advent of recent advances in instrumentation, accuracy and specificity of biomarker-based drug discovery program is improved. A key challenge in biomarker discovery is the choice of detection method, as diverse metabolites present in the physiological system pose varying levels of detection response with different instrumentation platforms. In biomarker-assisted early diagnosis, mass spectrometry-based metabolomics has a major advantage due to its capability of wide metabolite range coverage with great specificity. This review also discusses the advantage of biomarker-assisted discovery using metabolome analysis.
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ORIGINAL ARTICLES Top

Efficacy and safety of hepano tablet in liver disorder patients with abnormal liver function test: A randomized active controlled prospective clinical study p. 6
Satyendra Kumar, Arun Gupta, Meenakshi Revadekar, Sagar More, Abhay Kulkarni, Sunil S Borkar
DOI:10.4103/ddt.DDT_12_16  
Objective: Hepano Tablet is an Ayurvedic herbal formulation studied in pre-clinical models for safety and hepatoprotective efficacy. The current study was a randomized, active controlled, multicentre, prospective clinical study that aimed to evaluate hepatoprotective efficacy and safety of Hepano Tablets. Materials and Methods: Male and female liver diseases patients (18-65 years) with abnormal liver function tests were randomized to receive two tablets twice daily orally of either Hepano or a marketed comparator for 8 weeks with follow up at day 7, 14, 28 & 56 during treatment period and thereafter at day 84. Results were assessed from baseline to end of treatment basis changes in liver function tests and improvement in clinical symptoms of icterus in both the groups. Safety was assessed at all the visits basis changes in laboratory parameters and adverse event reporting for all cases who took at least one dose of the study drug. Results: Hepano Tablet and marketed comparator showed significant improvement in Liver functions - Serum Aspartate transaminase (AST), Alanine transaminase (ALT) and Total, Direct and Indirect Bilirubin Levels and a significant reduction in clinical symptoms of icterus that was comparable at all the visits. Conclusion: Hepano Tablets can significantly improve Liver Function Tests and clinical symptoms in liver disease patients and could be consumed safely.
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An ayurvedic formulation Sankat Mochan: A potent anthelmintic medicine p. 13
Khomendra Kumar Sarwa, Prabhat Kumar Vishwakarma, Vijendra Kumar Suryawanshi, Tilotma Sahu, Lokesh Kumar, Jaya Shree
DOI:10.4103/ddt.DDT_84_15  
Aim and Object: Sankat Mochan is an ayurvedic formulation used in the urban and rural area of India. This polyherbal formulation is used for general stomach problems including abdominal cramping and diarrhea. The present investigation evaluated the anthelmintic activity of an aqueous solution of an ayurvedic medicine Sankat Mochan. Materials and Method: Various concentrations (1%, 5%, and 10%) of medicine were used for anthelmintic activity on Pheretima posthuma. Piperazine citrate (10 mg/ml) was used as a reference standard and distilled water as a control. Result and Conclusion: The result showed that the Sankat Mochan possess anthelmintic activity more potent than that of piperazine citrate. Thus, Sankat Mochan may be used as a potent anthelmintic agent against helminthiasis.
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Development and validation of a liquid chromatography/tandem mass spectrometric method for determination of ethinyl estradiol in human plasma p. 17
Vijay Kotra, Nageswara Rao Ramisetti, Rajeesha Surapaneni, Sathish Kumar Konidala
DOI:10.4103/ddt.DDT_5_16  
Introduction: A simple and rapid bioanalytical liquid chromatography-tandem mass spectrometry (LC-MS/MS) method based on solid phase extraction (SPE) followed by liquid-liquid extraction (LLE) has been developed and validated for quantification of Ethinyl Estradiol in human plasma. Methods: API 5500 LC-MS/MS system with turbo ion-spray interface equipped with pumps (Shimadzu LC-20ADVP), an auto Sampler (Shimadzu SIL-HTC), analytical column SB C18 HT (50 x 3.0 mm, 1.8 μ) and data acquisition system and quantitation program (Applied Biosystems Analyst Software version 1.5, Thermo scientific) was used. The Positive ions were measured in MRM mode for the analyte and Ethinyl Estradiol-d4 used as an internal standard. A composition of 2 mM ammonium formate buffer: acetonitrile (20: 80 v/v) was used as mobile phase. The total run time was 4.0 min. The proposed method has been validated with in the linear range of 5.000–308.560 pg/ml for Ethinyl Estradiol. Results: The retention times of Ethinyl Estradiol and Ethinyl estradiol-d4 were 3.42 min ± 0.30 min and 3.45 min ± 0.30 min respectively. The intraday and interday precision values were within 1.58% to 10.86% and 4.62% to 19.74% respectively for Ethinyl estradiol. The overall recovery for Ethinyl estradiol was found to be 86.91%-103.15%. Conclusion: The method was validated as per ICH guidelines and it would be useful for bioequivalence and pharmacokinetic studies of Ethinyl Estradiol in human plasma.
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Comparative analysis of cost and efficacy for mono and dual therapy of antiepileptics among children p. 25
Easwaran Vigneshwaran, Monica Madineni, Karunakar Sake, Khaled M Alakhali, Shaik Alavudeen Sirajudeen, Noohu Abdullah Khan
DOI:10.4103/ddt.DDT_16_16  
Introduction: Developing countries contribute to major number of patients living with epilepsy, around five million people are living with epilepsy in India alone. Most of the epileptic children may require multiple antiepileptic therapy due to the failure of monotherapy. Basic research evidence suggest that sodium valproate and carbamazepine (CBZ) may have synergistic anticonvulsant effects when they are used together. In addition to that, chronic disorders make the patients economically weak and produce more burden. Aim and Objective: Therefore, this study was designed to compare the efficacy of valproate monotherapy with valproate and CBZ dual therapy. Methodology: It is a prospective, comparative study conducted at a secondary care referral hospital and private clinic. A nonprobabilistic convenient sampling was done to recruit the study subjects. A total of fifty subjects were recruited into the present study, and they were divided into two groups, i.e., monotherapy group (CBZ) and dual therapy group (CBZ and valproate). After providing appropriate counseling, subjects were interviewed to estimate the quality of life (QOL) using child version of TNO-AZL Children's Quality of Life questionnaire. Hospital patient records, prescription data from the pharmacy were also used to obtain the direct and indirect cost of treatment. Results: Our study results showed that monotherapy has a potential to produce a higher level of QOL than dual therapy. It also involved with decreased seizure frequency. Although there was no statistically significant difference in terms of cost for both the treatment groups, still dual therapy is associated with higher cost burden. The average costs per QOL and changes in the frequency of seizure are also identified to produce higher economic burden to the patients.Conclusion: Thus, the present study has concluded that monotherapy may be considered as better cost-effective treatment in partial seizures than dual therapy, unless if there is no treatment failure with monotherapy.
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