Journal of Pharmacovigilance and Drug Safety <p style="text-align: justify;">In the modern era of clinical application of knowledge of pharmacology, it is a big dilemma in hoosing between the good and the best drug. In making a decision for treatment planning clinician must consider the additional features of local and systemic issues, patient's economic status as well as potential adverse effect of the drug.</p> <p style="text-align: justify;">There are large number of drug trial going on world wide to observe the effect of a particular drug or a molecule. However, the scenario has changed drastically in last 20 years. What it was with the western/ developed world is now shifting over to developing world.</p> <p style="text-align: justify;">India is set to grab clinical trial business, making the subcontinent world's preferred destination for clinical trials. The big reason being low cost of trial along with friendly drug control system with&nbsp;competent work force and patient availability. Indian investigators and clinical trial research professionals have already demonstrated their medical and scientific skills in various global clinical trials. It is time now to capitalize on this opportunity. Indian investigators and research professionals can prove their ability and show to the world and register their presence now as well as for future.</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> en-US (Prof. (Dr.) Farhan Ahmad Khan) (Mohd. Qaish) Mon, 01 Feb 2021 00:00:00 +0000 OJS 60 Concept of Materiovigilance in Ayurveda <p><em>Incidents or any undesirable events occurring due to medical devices are being reported under Materiovigilance programme. Though concept of Materiovigilance are vibrant in various classical texts of Ayurveda, the ancient medical science, but a single hand information in this regard is lacking till date. </em><em>Present paper deals with available evidence of use of various types of medical devices and view of ancient Ayurveda scholars about their safe uses.</em></p> <p><em>Ayurveda Samhita records sample number of description about the safe use of medical devices in various context. V</em><em>arieties of Shastra (Instruments), Anushastras </em>(<em>Devices used for para-surgical process</em>)<em> and Yantra (Equipments) etc. being used as medical devices in surgical, para-surgical, Panchakarma procedures. Some of the instruments and equipment are also reported for their use in daily regime as a Bhajana (container) and in the preparation of herbomineral drugs. Specific materials to be used for the preparation of these devises along with their specific measurements have also been recorded. Possible effects of container on the content were well versed to the ancient experts of Ayurveda and are well reflected with various textual references.</em><em> Only need is </em><em>awareness of its proper use and reporting of undesirable incidence to avoid any harm or loss in future and for the betterment of the system.</em></p> <p>&nbsp;</p> Samta V. Tomar, Rasika Kolhe, Rabinarayan Acharya Copyright (c) 2020 Samta V. Tomar, Rasika Kolhe, Rabinarayan Acharya Thu, 31 Dec 2020 00:00:00 +0000 A Prospective Study on Hypolipidaemic Effects in Fresh and Dried Ginger Varieties <p><strong><em>Background</em></strong><em>:</em><em>The secretion of VLDL is influenced by the availability of apolipoprotein (apo) B in the liver and the activities of regulatory enzymes involved in the assembly and transport of VLDL, including microsomal transfer protein and acyl-coenzyme A (CoA):cholesterol acyltransferase&nbsp;. Dyslipidemia is well known factor to increase incidence of heart diseases. This may lead to development of atherosclerotic plaques which is major etiological factor for establishing coronary artery disease (CAD). Hypolipidemic drugs used in allopathy include Statins, Fibric acids, Niacin, and Resins but all have their low compliance due to frequent side effects. Medicinal herbs like Onion and Ginger are hypolipidemic agents commonly used as flavoring agents and making foods spicy and tasty. We have compared hypolipidemic potential between these two medicinal herbs. </em></p> <p><strong><em>Methods: </em></strong><em>The study&nbsp; was conducted at Ghurki Trust teaching hospital, Lahore from January to June 2017. Eighty secondary hyperlipidemic patients were enrolled after getting written consent which was approved by Ethics committee of the hospital. They were divided in two equal groups comprising 40 patients in each group. Group-I was treated by Ginger 10 grams daily in three divided doses for 2 months. Group-II was advised to take Onion 200 grams daily in divided amount with each meal i.e., breakfast, lunch, and dinner for two months. </em></p> <p><strong><em>Results:</em></strong> <em>After two months therapy it was observed by statistical analysis that 10 grams ginger reduced TC (total cholesterol) of 38 hyperlipidemic patients 12.4 gm/dl and LDL-C (low density lipoprotein cholesterol) 27.3&nbsp; mg/dl. In group-II, onion reduced TC in 35 patients 17.9 mg/dl and LDL-C 14.8 mg/dl. Changes in tested parameters are significant biostatistically with p-values &lt;0.01 to &lt;0.001. </em></p> <p><strong><em>Conclusion: </em></strong><em>We concluded from this research work that Onion and Ginger reduces risk of CAD by decreasing plasma total cholesterol and LDL cholesterol. </em></p> <p><em>&nbsp;</em></p> <p>&nbsp;</p> Mohd Shah Murad, Shahina ., Abdul Qudoos Arain, A Azim Azmi Copyright (c) 2020 Mohd Shah Murad, Shahina ., Abdul Qudoos Arain, A Azim Azmi Thu, 31 Dec 2020 00:00:00 +0000 Concept of Materiovigilance and Importance in AYUSH <p><em>The excerpt of this paper was read as a part of invited lecture during the </em><em>National Webinar on Pharmacovigilance of Ayurveda Sidhha Unani and Homeopathy (ASU &amp; H) Drugs - AYUSHSURAKSHA 2020 through Online Zoom. It was organized by the Intermediary Pharmacovigilance Centre, National Institute of Unani Medicine, Bangalore and sponsored by the Ministry of AYUSH, Govt. of India, New Delhi on 16.9.2020. </em></p> <p>&nbsp;</p> <p>&nbsp;</p> Syed Ziaur Rahman Copyright (c) 2020 Syed Ziaur Rahman Thu, 31 Dec 2020 00:00:00 +0000 How safe are intramedullary stainless-steel nails for long bone fractures? <p><em>Femoral and tibial fractures are usually the result of high-energy trauma such as road traffic accidents, fall from heights and trauma in high-speed contact sports. Most femoral and tibial shaft fractures are treated surgically. Several studies have shown that early surgical stabilization is associated with reduction of complications and mortality. An intramedullary nail is a metal rod that is inserted into the medullary cavity of a bone and across the fracture in order to provide a solid support for the fractured bone. Intramedullary nailing is currently considered the “gold standard” for treatment of femoral and tibial shaft fractures. Proposed advantages of intramedullary nailing include short hospital stay, rapid union of the fracture and early functional use of the limb. Intramedullary nailing aims to preserve the anatomical structure of fracture site and to provide a proper environment for fracture healing. The present case report further enlightens the safe use of Intramedullary nailing for long bone fracture.</em></p> <p>&nbsp;</p> <p>&nbsp;</p> Sumeet Singhal Copyright (c) 2020 Sumeet Singhal Thu, 31 Dec 2020 00:00:00 +0000