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  Citation statistics : Table of Contents
   2013| July-September  | Volume 4 | Issue 3  
    Online since July 22, 2013

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Qualitative research
Vibha Pathak, Bijayini Jena, Sanjay Kalra
July-September 2013, 4(3):192-192
DOI:10.4103/2229-3485.115389  PMID:24010063
  42 44,479 7,177
The effects of oral pregabalin on post-operative pain of lower limb orthopedic surgery: A double-blind, placebo-controlled trial
Godrat Akhavanakbari, Masood Entezariasl, Khatereh Isazadehfar, Tiba Mirzarahimi
July-September 2013, 4(3):165-168
DOI:10.4103/2229-3485.115376  PMID:24010057
Background: Post-operative pain is one of the problems, wherein lack of control on it has many side-effects such as tachycardia, hypertension, myocardial ischemia, decreased alveolar ventilation, and poor wound healing. Aims: In this study, we evaluated the pre-operative administration of pregabalin sufficiency and security in relieving post-operative pain after lower limb orthopedic surgery and reducing the need for opioids and their possible side-effects. Materials and Methods: This study is a randomized, double-blind clinical trial. It was performed on 60 patients under lower limb surgery by spinal anesthesia. Patients were randomly allocated to two groups, one group has received a 150 mg pregabalin capsule 2 h before surgery and the other group has received placebo as a control. In both groups at 2, 6, 12, and 24 h after surgery, the patients were evaluated and the pain score, the score of sedation, incidence of nausea and vomiting was recorded in the checklists. Then, the data were analyzed by SPSS v16. Results: Visual analog pain scores at all hours in pregabalin group significantly reduced compared to the placebo group ( P < 0.0001). Also, in the pregabalin group nausea and vomiting scores at all hours, sedation levels at 2 h and 6 h post-operatively, and pethidine consumption in all hours have significantly been reduced. Conclusion: A single pre-operative oral dose of pregabalin 150 mg is an effective method for reducing post-operative pain and pethidine consumption in patients undergoing orthopedic surgery.
  14 4,261 734
Knowledge, attitude, and practices toward ayurvedic medicine use among allopathic resident doctors: A cross-sectional study at a tertiary care hospital in India
Suchita R Gawde, Yashashri C Shetty, Dattatray B Pawar
July-September 2013, 4(3):175-180
DOI:10.4103/2229-3485.115380  PMID:24010059
Context: Ayurveda is most commonly practiced form of complementary and alternative medicine (CAM) in India. There are very few studies showing the knowledge, attitude, and practices (KAP) of allopathic doctors about Ayurvedic drugs and its use. Aims: The study was initiated to assess KAP toward Ayurvedic medicine use among allopathic resident doctors. Settings and Design: Cross-sectional and prospective study. Materials and Methods: After obtaining permission from the Institutional Ethics Committee, allopathic resident doctors from clinical departments were approached personally. They were given pre-formed validated questionnaire to assess KAP toward Ayurvedic medicine use. Statistical Analysis Used: Descriptive statistics. Results: Allopathic residents had little knowledge about basic concepts of Ayurveda, that is, 'panchakarma' and 'tridosha'. Majority residents (99%) had no opportunity to learn basics of Ayurveda, but 67% residents prescribed Ayurvedic medicines to patients. However, many residents (76%) mentioned that cross practice should not be allowed due to lack of knowledge. One resident knew that cross-practice was not allowed by law. The commonly prescribed proprietary Ayurvedic medicines were Liv-52 (39%), Shatavari (13%), Cystone (12%) and common ailments for which these medicines prescribed were liver disorders (34%), arthritis (18%), cough and cold (13%), kidney stones (11%), and piles (10%). Nearly 76% residents felt incorporation of Ayurveda with modern medicine would attract more patients and at the same time most residents (92%) agreed that Ayurvedic medicines need scientific testing before use. Though 50% of the residents agreed for voluntary training in Ayurveda, 80% denied compulsory training. Nearly 63% residents recommended Ayurveda among all CAMs. Most of residents heard of Ayurveda from their colleagues. Conclusions: This study reveals that allopathic resident doctors had little knowledge about Ayurveda and Ayurvedic medicine use but engaged in prescription of Ayurvedic medicines. So some interventions should be taken to increase the knowledge and awareness of allopathic resident doctors about Ayurvedic medicine use.
  11 7,997 995
Public awareness and perception of clinical trials: Quantitative study in Pune
Veena D Joshi, Gauri A Oka, Aditi A Kulkarni, Varada V Bivalkar
July-September 2013, 4(3):169-174
DOI:10.4103/2229-3485.115378  PMID:24010058
Context: Studies have reported that clinical research has experienced tremendous growth during past few decades with many multinational pharmaceutical companies recruiting millions of Indians in clinical trials (CTs). However, there is hardly any literature that talks about the participants, their knowledge, and awareness of CTs. It is important that the general public is aware about CTs so that they can take their own informed decision to participate in CTs. Aim: To assess public awareness, perceptions, and attitudes toward CTs and their views on various methods to create awareness about CTs. Materials and Methods: Cross sectional survey was conducted with 200 non trial participants (NTPs) and 40 trial participants (TPs). Results: TPs were significantly (P < 0.0001) older than NTPs. More than 80% of both TPs and NTPs mentioned participation in CT helps advance medical science and strongly felt that there is a need to create awareness about CTs. Nearly 70% of TPs could not remember the phase of the trial while 20% did not know which type of trial they had participated . The main reason for participation in the trial was physician's advice. About 80% of both TPs and NTPs felt that participation in CT will increase with free medications and advice from friends/relatives who had good experience with trial. Conclusion: Results of this pilot study revealed need to create CT awareness among the general public. However, considering ethno-cultural, regional, and literacy-level differences throughout the country, a nationwide study would be appropriate to provide reliable results about awareness of CTs among Indians.
  10 4,663 470
Clinical trials in India: Where do we stand globally?
Sandhiya Selvarajan, Melvin George, S Suresh Kumar, Steven Aibor Dkhar
July-September 2013, 4(3):160-164
DOI:10.4103/2229-3485.115373  PMID:24010056
Aims: To evaluate the trend of clinical trials in India over the last 4 years compared to the well-established countries using clinical trial registries since the advent of clinical trial registry of India (CTRI). Materials and Methods: The data of clinical trials registered in India, United States (US), and European Union (EU) were obtained from websites of CTRI, clinicaltrial.gov and EU clinical trial registry, respectively from July 20, 2007 to August 29, 2011 for a period of 4 years. Trials registered in Australia, Canada, China, and Japan were obtained from WHO's international clinical trial registry platform for the same period. We used search words for the common diseases such as diabetes, hypertension, etc., Results: The total number of clinical trials registered during the study period was 67,448 across seven study nations. Clinical trials from India constituted only 2.7% of the total number of trials carried out, compared to US constituting 47% of the total number of trials registered, followed by 18% from EU and 11% from Japan. However, India, China, and Japan have been found to show an increase of 3.7%, 5.1%, and 13.1% increase in the number of trials registered in 2011 compared to 2007. In contrast, US and EU showed a decline of 11.3% and 11.95% respectively in the total number of trials registered in 2011 compared to 2007. Conclusions: Although India shows gradual increase in trials registered since the advent of CTRI, still it continues to lag behind established countries in clinical research.
  7 3,919 668
Ensuring quality in the coding process: A key differentiator for the accurate interpretation of safety data
G Jaya Nair
July-September 2013, 4(3):181-185
DOI:10.4103/2229-3485.115383  PMID:24010060
Medical coding and dictionaries for clinical trials have seen a wave of change over the past decade where emphasis on more standardized tools for coding and reporting clinical data has taken precedence. Coding personifies the backbone of clinical reporting as safety data reports primarily depend on the coded data. Hence, maintaining an optimum quality of coding is quintessential to the accurate analysis and interpretation of critical clinical data. The perception that medical coding is merely a process of assigning numeric/alphanumeric codes to clinical data needs to be revisited. The significance of quality coding and its impact on clinical reporting has been highlighted in this article.
  4 4,873 448
Clinical trial registration in physiotherapy research
Sundar Kumar Veluswamy, Abraham Samuel Babu, Prachi Shah, Arun Gundmi Maiya
July-September 2013, 4(3):191-192
DOI:10.4103/2229-3485.115387  PMID:24010062
  3 2,502 356
The penumbra of randomized control trials
Arun S Nanivadekar
July-September 2013, 4(3):157-159
DOI:10.4103/2229-3485.115371  PMID:24010055
Pre-occupation with randomized control trials as the basis of evidence-based medicine has increasingly shadowed other study designs over the last half a century. These include surveys, case-control studies, and case-cohort studies. They have the potential to overcome several ethical and cost constraints, but depend on the embedding of research in routine practice, emphasis on relevant but limited, accurate, and complete data, harnessing of information technology for this purpose, and epidemiological and statistical literacy among clinicians. Only then will it be possible to nurture and network research-oriented practices by therapeutic areas. Given these, the alternative study designs can pave the way to regulatory reforms that will ultimately benefit the discoverers, approvers and users of health-care tools.
  2 2,814 387
Impact of recent regulations
Bobby George
July-September 2013, 4(3):155-156
DOI:10.4103/2229-3485.115369  PMID:24010054
  - 2,233 419
An insight into the emerging role of regional medical advisor in the pharmaceutical industry
Sandeep Kumar Gupta, Roopa P Nayak
July-September 2013, 4(3):186-190
The position of regional medical advisor (RMA) is relatively new in the pharmaceutical industry and its roles and responsibility are still evolving. The RMA is a field based position whose main mission is to foster collaborative relationships with the key opinion leaders (KOLs) and to facilitate the exchange of unbiased scientific information between the medical community and the company. Field-based medical liaison teams are expanding world-wide as part of the pharmaceutical industry's increased focus on global operations including emerging markets. Now, the position of the RMA has evolved into comprehensive, complex, highly interactive, targeted, highly strategic, innovative, and independent role since its inception by the Upjohn Company in 1967. The major objective of the RMA is to develop the professional relationships with the health-care community, particularly KOLs, through peer-to-peer contact. The RMA can facilitate investigator-initiated clinical research proposals from approval until completion, presentation, and publication. It is possible for a RMA to have valuable access to KOLs through his expertise in the clinical research. The RMA can assist in the development, review, and follow-up of the clinical studies initiated within the relevant therapeutic area at the regional/local level. The RMA can lead regional/local clinical projects to ensure that all clinical trials are conducted in compliance with the International Conference of Harmonisation Good Clinical Practice (ICH GCP) guidelines.
  - 4,458 950