Perspectives in clinical research Journal Impact Factor & Information

Publisher: Medknow Publications

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Current impact factor: 0.00

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ISSN 2229-5488

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Medknow Publications

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    • Non-commercial
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    • All titles are open access journals
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Publications in this journal

  • [Show abstract] [Hide abstract]
    ABSTRACT: The aim of the following study is to evaluate the efficacy and safety of Caralluma fimbriata extract (CFE) in overweight and obese individuals in a prospective, randomized, placebo controlled trial. Commercially available CFE was assessed in overweight and obese individuals. A total of 89 patients were randomized into a treatment group (n = 47) and placebo group (n = 42) to receive either CFE in the form capsules/oral 500 mg b.d. for 12 weeks or matching placebo in similar way. Patients were evaluated clinically and biochemically at 4, 8 and 12 weeks for anthropometric measurements, appetite, biochemical investigations and other safety parameters. At the end of study period both CFE and placebo for 12 weeks caused only numerical reduction in weight, body mass index, waist circumference, hip circumference and waist hip ratio in overweight and obese individuals. However, these parameters failed to attain significant statistical levels (P ≥ 0.05). CFE and placebo both failed to elucidate any modification of the appetite. There were no significant changes in the biochemical and clinical parameters in both the test and placebo group. However, CFE was well-tolerated and adverse events noted were mild and transient in nature. A commercially available extract of CFE in an oral dose of 1 g/day claimed to have anti-obesity effect failed to yield any positive results on anthropometry and appetite in overweight and obese individuals beyond placebo. There were also no significant differences in the clinical and biochemical parameters. However, CFE was well tolerated. Thereby, underscoring the need to carry more research before CFE is recommended as an anti-obesity drug.
    Perspectives in clinical research 01/2015; 6(1):39-44. DOI:10.4103/2229-3485.148812
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    ABSTRACT: To compare the effect of honey, chlorhexidine mouthwash and combination of xylitol chewing gum and chlorhexidine mouthwash on the dental plaque level. Ninety healthy dental students, both male and female, aged between 21 to 25 years participated in the study. The subjects were randomly divided into three groups, i.e. the honey group, the chlorhexidine gluconate mouthwash group and the combination of xylitol chewing gum and chlorhexidine (CHX) mouthwash group. The data was collected at the baseline, 15(th) day and 30(th) day; the plaque was disclosed using disclosing solution and their scores were recorded at six sites per tooth using the Quigley and Hein plaque index modified by Turesky-Gilmore-Glickman. Statistical analysis was carried out later to compare the effect of all the three groups. P ≤ 0.05 was considered as statistically significant. Our result showed that all the three groups were effective in reducing the plaque but post-hoc LSD (Least Significant Difference) showed that honey group and chlorhexidine + xylitol group were more effective than chlorhexidine group alone. The results demonstrated a significant reduction of plaque indices in honey group and chlorhexidine + xylitol group over a period of 15 and 30 days as compared to chlorhexidine.
    Perspectives in clinical research 01/2015; 6(1):53-7. DOI:10.4103/2229-3485.148819
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    ABSTRACT: The primary objective of this study was to evaluate the knowledge, attitude, and practices (KAP) of the healthcare professionals about pharmacovigilance in Dhanalakshmi Srinivasan Medical College and Hospital (DSMCH), Perambalur (Tamil Nadu), a tertiary care teaching hospital. The second primary objective was to assess the causation of underreporting of adverse drug reactions (ADRs) as it needs to be well-assessed in India. The secondary objective was to compare the findings of this study with the results of the published studies from India on evaluation of the KAP of pharmacovigilance among healthcare professional. A cross-sectional study was carried out using a pretested questionnaire. The questionnaire was designed to assess the KAP regarding pharmacovigilance. The healthcare professionals (doctors, nurses, and pharmacists) working in the DSMCH, Perambalur (Tamil Nadu) during the study period were included. Only those who gave their consent to participate were included in the study. The data was analyzed by using the Statistical Package for Social Sciences (SPSS) statistical software, version 16. One hundred and fifty pretested questionnaires were distributed among the healthcare professionals and 101 responded. 62.4% healthcare workers gave correct response regarding the definition of pharmacovigilance. 75.2% of healthcare workers were aware regarding the existence of a National Pharmacovigilance Program of India. 69.3% healthcare professional agreed that ADR reporting is a professional obligation for them. Among the participants, 64.4% have experienced ADRs in patients, but only 22.8% have ever reported ADR to pharmacovigilance center. Unfortunately only 53.5% healthcare workers have been trained for reporting adverse reactions. But, 97% healthcare professionals agreed that reporting of ADR is necessary and 92.1% were of the view that pharmacovigilance should be taught in detail to healthcare professional. This study demonstrated that knowledge and attitude towards pharmacovigilance is gradually improving among healthcare professionals, but unfortunately the actual practice of ADR reporting is still deficient among them.
    Perspectives in clinical research 01/2015; 6(1):45-52. DOI:10.4103/2229-3485.148816
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    ABSTRACT: Respiratory studies are complex on account of specific therapeutic knowledge that is needed and various instruments that are used for the management of this condition. Monitoring a respiratory study requires knowledge of the specific disease and associated guidelines. The intent of this article is to help clinical research professionals understand the technicalities, challenges, and the nuances of performing respiratory studies.
    Perspectives in clinical research 01/2015; 6(1):15-9. DOI:10.4103/2229-3485.148798
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    ABSTRACT: The advancement and development of new drugs and treatment strategies increase the risk of unusual Adverse Events (AEs) in HIV patients. The objective of our study was to assess the incidence, types and nature of AEs in HIV positive subjects. Patients with WHO stage IV disease irrespective of the CD4 cell count, or WHO stage III disease with a CD4 cell count <350 cell/cu. Mm, or, WHO stage I or II disease with a CD4 cell count of <200 cells/cu. mm, and on prior anti-retroviral therapy for not more than six months preceding the observation date, were included in the study. After initiation of therapy, the patients were examined for the occurrence any adverse events including the type and severity, or any other abnormal laboratory findings. Causality assessment of the adverse events was done using the Naranjo's scale. Out of 327 patients studied prospectively, 43 patients developed AEs. Out of these, 23 (53.5%) were males and 20 (46.5%) were females. A total of 53 (16.21%) AEs were reported. Antitubercular drugs caused the maximum AEs (28.3%) followed by zidovudine (20.7%), nevirapine (15.0%) and efavirenz (5.6%). Stavudine, ethambutol, sulfamethoxazole and trimethoprim, and atazanavir were also responsible for 3.7% of AEs individually. Causality assessment done according to the Naranjo's scale revealed that 66.04% AEs were 'probable' and 33.96% were 'possible'. Anemia, hepatitis and dermatological adverse effects are the most common AEs. Antitubercular drugs contributed significantly for the incidence of AEs in these patients. Frequency of AEs was slightly more in males compared to females.
    Perspectives in clinical research 01/2015; 6(1):34-8. DOI:10.4103/2229-3485.148808
  • Perspectives in clinical research 01/2015; 6(1):1-3. DOI:10.4103/2229-3485.148786
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    ABSTRACT: Increased focus on ethical review of research demands a number of improvements in the existing system. Although these are being implemented, some factors that have received less attention in the past could be examined. One of these is conflict of interest. Such conflicts could exist for investigators, ethics committee (EC) members, and even the regulators. Guidance for identification and management of conflicts has been issued by many countries and Indian rules also speak about these conflicts. Greater clarity would help investigators and ECs manage conflicts more effectively. It is admitted that conflicts cannot be done away with, but their timely identification, disclosure, and management can reduce their impact and bring more transparency and accountability to trials in this country.
    Perspectives in clinical research 01/2015; 6(1):10-4. DOI:10.4103/2229-3485.148794
  • Perspectives in clinical research 01/2015; 6(1):64-7. DOI:10.4103/2229-3485.148823
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    ABSTRACT: Osteoarthritis (OA) is a major public concern as it is one of the leading causes of morbidity and lays a huge medical and economic burden on health resources. Early detection of OA has been a clinical challenge as early signs of joint inflammation are often not evidently identifiable on routine radiographic images. This presents a dire unmet medical need for a biomarker, which could detect early signs of joint inflammation much before irreversible joint damage and radiographic changes set in. Besides, the treatment of OA has remained mainly symptomatic. A disease modifying OA drug (DMOAD), which can act as targeted anti-OA therapy has not been able to receive regulatory approval yet. The clinical development of a DMAOD too warrants the need of a biomarker; which can act as a surrogate clinical endpoint used to monitor therapeutic efficacy and to validate a clinically meaningful change within the restricted time frame of a clinical study. In this regard, the current review focuses on cartilage oligomeric matrix protein (COMP), a potential OA biomarker which has shown significant clinical promise as a tool for early detection, therapeutic monitoring, prognostication and drug development for OA. This brief review is pivoted around the findings of selected relevant publications from PubMed indexed journals.
    Perspectives in clinical research 01/2015; 6(1):4-9. DOI:10.4103/2229-3485.148792
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    ABSTRACT: This article is the first in a series exploring common pitfalls in statistical analysis in biomedical research. The power of a clinical trial is the ability to find a difference between treatments, where such a difference exists. At the end of the study, the lack of difference between treatments does not mean that the treatments can be considered equivalent. The distinction between "no evidence of effect" and "evidence of no effect" needs to be understood.
    Perspectives in clinical research 01/2015; 6(1):62-3. DOI:10.4103/2229-3485.148821
  • Perspectives in clinical research 07/2014; 5(3):141. DOI:10.4103/2229-3485.134324
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    ABSTRACT: Manuscript authors of scientific journals are expected to report if their studies were conducted according to international and national ethical guidelines and inform readers regarding ethics approval and informed consent obtained from participants and/or their legally acceptable representative/s. In the present study we assessed the reporting practices of ethics approval and informed consent (assent in case of pediatric studies) in four Indian journals.
    Perspectives in clinical research 07/2014; 5(3):129-33. DOI:10.4103/2229-3485.134316
  • Perspectives in clinical research 07/2014; 5(3):93-4. DOI:10.4103/2229-3485.134295
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    ABSTRACT: Data query (DQ) rate per case record form (CRF) page is an index of quality of clinical trial data, which can be affected by the phase of clinical trial, the therapeutic area, and the country, where investigator site is located.
    Perspectives in clinical research 07/2014; 5(3):121-4. DOI:10.4103/2229-3485.134312
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    ABSTRACT: Over the last two decades Business Process Outsourcing (BPO) has evolved as much mature practice. India is looked as preferred destination for pharmaceutical outsourcing over a cost arbitrage. Among the biometrics outsourcing, statistical programming and analysis required very niche skill for service delivery. The demand and supply ratios are imbalance due to high churn out rate and less supply of competent programmer. Industry is moving from task delivery to ownership and accountability. The paradigm shift from an outsourcing to consulting is triggering the need for competent statistical programmer. Programmers should be trained in technical, analytical, problem solving, decision making and soft skill as the expectations from the customer are changing from task delivery to accountability of the project. This paper will highlight the common issue SAS programming service industry is facing and skills the programmers need to develop to cope up with these changes.
    Perspectives in clinical research 07/2014; 5(3):95-9. DOI:10.4103/2229-3485.134300
  • [Show abstract] [Hide abstract]
    ABSTRACT: The vital responsibility of Institutional Ethics Committee (IEC) members is to ensure the safety of the subjects participating in clinical trials. Hence, it is essential for IEC members to be aware of the common pharmacovigilance strategies followed during clinical trials. However, the information about the knowledge, attitude, and practice of IEC members regarding the pharmacovigilance activities followed during clinical trials is scarce worldwide, especially in India. Hence, this cross-sectional study was designed to assess the knowledge, attitude, and practice of IEC members of 10 hospitals of Kolkata, India.
    Perspectives in clinical research 07/2014; 5(3):115-20. DOI:10.4103/2229-3485.134310