Current Issue : January - March Volume : 2018 Issue Number : 1 Articles : 7 Articles
With the increase in number of patients, multiple diseases and complex therapeutic regimen the chances of drug\ninteraction is widening. Poly pharmacy is an unavoidable condition with age, leading to elevated healthcare costs, morbidity and\nmortality. A prospective observational study was conducted in outpatient department of a tertiary care hospital for a period of 4\nmonths. Potential drug-drug interactions per prescriptions and their clinical effects were evaluated. A total of 300 prescriptions\nof all age groups ranging from 1 to 75 years satisfying the inclusion criteria were collected. The complete past medical and\nmedication history of the patients were collected in the patient data collection form designed especially for the study. The most\ncommon exposure to various drug combinations were observed with prescriptions on medications for high blood pressure and\ncardiovascular drugs (62%), antibiotics (46%), antacids (47%), psychotropics (37%) and hypo-cholestrolemia drugs (20%).\nSome of the idiosyncratic reactions observed under the study were depression, insomnia, confusion, anxiety. A total of 840\npotential drug-drug interactions were detected in 300 total collected prescriptions, NSAIDS, �²-blockers, diuretics, statins are the\nmain class of drugs mostly interacted in the study. This was common in patients between 45-75 age groups. Out of this many\ndrug-drug interactions approximately 60% were pharmacodynamics and 40% were pharmacokinetic interactions. All health\ncare providers especially the clinical pharmacist must be able to assess, classify drug-drug interactions, recognize how to\nmanage, monitor and notifying them to prescriber about the potential reactions which could decrease the harmful effects and\nensure patient safety....
Bronchial artery angiography with embolization has become a mainstay in the treatment of hemoptysis. Major complications are rare and immediate clinical success defined as cessation of hemorrhage. Bronchial artery embolization offers a minimally invasive procedure for even the most compromised patient....
Objective. To evaluate the clinical therapeutic efficacy and safety of JieDuTongLuoShengJin granules + HCQ in patients with pSS.\nMethods. 40 patients with low-activity-level pSS and without visceral involvement participated in this study and were randomized\nto receive either JieDuTongLuoShengJin granules with HCQ or placebo with HCQ. Patients and investigators were blinded to\ntreatment allocation.The primary endpoint was week 12 ESSPRI score, while secondary endpoints included ESSDAI, salivary and\nlacrimal gland function, and some laboratory variables. Safety-related data were also assessed. Results. Comparing with the placebo\ngroup, the treatment group experienced statistically significant improvement in the mean change from baseline for the primary\nendpoint of ESSPRI score and also in PGA. Moreover, in comparison with baseline values, the treatment group had significantly\nimproved ESSDAI score, unstimulated saliva flow rate, and several laboratory variables. However, upon comparison of the two\ngroups, there were no significant differences for them.Theincidence of AEs was 10.0%, one in treatment group and three in placebo\ngroup. Conclusion. Treatment with a combination of JieDuTongLuoShengJin granules with HCQ is effective in improving patients�\nsubjective symptoms and some objective indicators of pSS. These results indicate that JieDuTongLuoShengJin is promising as a safe\nand effective treatment of pSS....
Background: Type 2 Diabetes (T2D) is associated with increased risk of dementia. We aimed to determine the\nfeasibility of a randomised controlled trial (RCT) examining the efficacy of exercise on cognition and brain structure\nin people with T2D.\nMethods: A 6-month pilot parallel RCT of a progressive aerobic- and resistance-training program versus a gentle\nmovement control group in people with T2D aged 50ââ?¬â??75 years (n = 50) at the University of Tasmania, Australia.\nAssessors were blinded to group allocation. Brain volume (total, white matter, hippocampus), cortical thickness and\nwhite matter microstructure (fractional anisotrophy and mean diffusivity) were measured using magnetic resonance\nimaging, and cognition using a battery of neuropsychological tests. Study design was assessed by any changes (during\nthe pilot or recommended) to the protocol, recruitment by numbers screened and time to enrol 50 participants;\nrandomisation by similarity of characteristics in groups at baseline, adherence by exercise class attendance; safety by\nnumber and description of adverse events and retention by numbers withdrawn.\nResults: The mean age of participants was 66.2 (SD 4.9) years and 48% were women. There were no changes to the\ndesign during the study. A total of 114 people were screened for eligibility, with 50 participants with T2D enrolled over\n8 months. Forty-seven participants (94%) completed the study (23 of 24 controls; 24 of 26 in the intervention group).\nBaseline characteristics were reasonably balanced between groups. Exercise class attendance was 79% for the\nintervention and 75% for the control group. There were 6 serious adverse events assessed as not or unlikely\nto be due to the intervention. Effect sizes for each outcome variable are provided.\nConclusion: This study supports the feasibility of a large scale RCT to test the benefits of multi-modal\nexercise to prevent cognitive decline in people with T2D. Design changes to the future trial are provided....
Clinical research is a robust process which involves billions of dollars and several years of time to test an\ninvestigational drug or a device in the clinical trials conducted on human subjects for the determination of the product efficacy\nin curing the disease or for implementing a new treatment procedure respectively. The success of a process or a project depends\non how well it is planned, organized, implemented and managed. This is also known as project management. The current study\ndeals with the application of project management in executing clinical trials. Clinical trials involve huge supply of resources,\nenergy, effort, man power and time in a way to acquire the desired results which is exceptionally not very productive. Utilization\nof the project management methodologies along with the conventional techniques would increase the chances of execution of\nclinical trials in a much cost and resource effective and time-efficient manner. In this article, different methods of project\nmanagement, data collection and analysis were discussed especially to cut down the costs, efforts and time spent in executing a\nclinical trial successfully in this fast paced environment in an efficient way....
Objective. The aim of this review is to characterize current status of global TCM clinical trials registered in ClinicalTrials.gov.\nMethods.We examined all the trials registered within ClinicalTrials.gov up to 25 September 2015, focusing on study interventions to\nidentify TCM-related trials, and extracted 1,270 TCM trials fromthe data set. Results. Overall, 691 (54.4%) trials were acupuncture,\nand 454 (35.8%) trials were herbal medicines. Differences in TCM trial intervention types were also evident among the specific\ntherapeutic areas. Among all trials, 55.7% that were small studies enrolled <100 subjects, and only 8.7% of completed studies had\nreported results of trials. As for the location, the United States was second to China in conducting themost TCMtrials. Conclusion.\nThis review is the first snapshot of the landscape of TCM clinical trials registered in ClinicalTrials.gov, providing the basis for\ntreatment and prevention of diseases within TCM and offering useful information that will guide future research on TCM....
Background. Common cold is one of the most frequently occurring illnesses in primary healthcare services and represents\nconsiderable disease burden. Common cold of Qi-deficiency syndrome (CCQDS) is an important but less addressed traditional\nChinese medicine (TCM) pattern. We designed a protocol to explore the efficacy, safety, and optimal dose of Shen Guo Lao Nian\nGranule (SGLNG) for treatingCCQDS.Methods/Design.This is amulticenter, randomized, double-blind, placebo-controlled, phase\nII clinical trial. A total of 240 eligible patients will be recruited fromfive centers. Patients are randomly assigned to high-dose group,\nmiddle-dose group, low-dose group, or control group in a 1 : 1 : 1 : 1 ratio. All drugs are required to be taken 3 times daily for 5 days\nwith a 5-day follow-up period. Primary outcomes are duration of all symptoms, total score reduction on Jackson�s scale, and TCM\nsymptoms scale. Secondary outcomes include every single TCM symptom duration and score reduction, TCM main symptoms\ndisappearance rate, curative effects, and comparison between Jackson�s scale and TCMsymptomscale. Ethics and Trial Registration.\nThis study protocol was approved by the Ethics Committee of Clinical Trials and Biomedicine of West China Hospital of Sichuan\nUniversity (number IRB-2014-12) and registered with the Chinese Clinical Trial Registry (ChiCTR-IPR-15006349)....
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