International Journal of Basic & Clinical Pharmacology
Not a member yet
3901 research outputs found
Sort by
Evaluation of pharmacovigilance related knowledge, attitude and practice among healthcare professionals and students in a tertiary-care hospital: a cross-sectional study
Full text linkBackground: Pharmacovigilance (PV) plays a critical role in ensuring medication safety by identifying, evaluating and preventing adverse drug reactions (ADRs). Assessing the knowledge, attitude and practice (KAP) of healthcare professionals is essential for strengthening ADR reporting systems. To assess the knowledge, attitude and practice (KAP) related to pharmacovigilance among healthcare professionals and students and to analyse the association of KAP scores with age and professional category.
Methods: This cross-sectional study utilized the ICMR pharmacovigilance KAP questionnaire to assess responses from 332 participants. Descriptive statistics were applied, Kruskal–Wallis’s test for intergroup comparison and Spearman’s correlation was used to evaluate associations between age and KAP scores. Data on professional experience were not available. A p value<0.05 was considered statistically significant.
Results: The mean (±SD) knowledge, attitude and practice scores were 4.57±1.30, 3.20±0.74 and 4.29±1.46, respectively. Knowledge (H=9.68, p=0.046) and practice (H=9.83, p=0.043) differed significantly across professions. Age showed a very weak, non-significant correlation with knowledge (ρ=0.103, p=0.060) and no correlation with attitude (ρ=0.013, p=0.809), but a weak significant correlation with practice (ρ=0.188, p=0.0006).
Conclusion: Participants demonstrated moderate knowledge and practice scores with overall positive attitudes. Knowledge and practice varied significantly across professions, while attitude did not. Age showed only weak associations with KAP domains. These findings indicate the need for profession-specific pharmacovigilance training, particularly to strengthen knowledge and practice among students and nursing staff
Prescribing complexity of oral hypoglycemic fixed-dose combinations in India: development and application of a novel complexity scoring tool
Full text linkBackground: Fixed-dose combinations (FDCs) of oral hypoglycemic agents are extensively used in India for simplifying type 2 diabetes mellitus (T2DM) treatment and improving adherence. There are long-standing concerns regarding irrational FDCs, limited dose flexibility, and weak alignment with clinical guidelines. Currently, no structured framework exists to assess the prescribing complexity of these FDCs. Objectives of the study were to characterize oral hypoglycemic agent FDCs approved and marketed in India and to develop and apply a novel prescribing complexity score for oral hypoglycemic fixed-dose combinations (PCS-OHA-FDC).
Methods: A secondary analysis of oral hypoglycemic agent FDCs approved by the Central Drugs Standard Control Organization and listed in standard drug information sources was conducted. Each FDC was evaluated across four domains: number of active pharmaceutical ingredients, therapeutic duplication, dose flexibility, and guideline concordance. Domain scores were summed to derive an overall prescribing complexity score and to classify FDCs as low, moderate, or high complexity.
Results: 57 OHA FDCs were included in the analysis. Two-drug FDCs constituted the majority (40/57; 70.2%), while there were 17 three-drug FDCs (29.8%). No FDC demonstrated direct therapeutic duplication. Limited dose flexibility (7/57; 12.3%) and conditional or absent guideline support (40/57; 70.17%) was common. Using the prescribing complexity score for OHA-FDCs (PCS-OHA-FDC), most formulations were classified as low complexity (42/57; 73.68%), with the remainder showing moderate complexity (15/57; 26.31%). No FDC met criteria for high prescribing complexity.
Conclusions: The PCS-OHA-FDC offers a practical tool to quantify prescribing complexity and highlights important gaps between market availability and guideline-based diabetes care in India.
The efficacy of endoxifen in treating borderline personality disorder in young female patients: reports of two cases
Full text linkThis case reports presents two young female patients diagnosed with borderline personality disorder (BPD) who were treated with endoxifen. The report details their clinical presentations, previous treatment histories, the rationale for initiating endoxifen as adjunctive therapy, and the subsequent clinical outcomes. The objective is to understand the efficacy and safety of endoxifen in managing BPD symptoms, focusing particularly on impulsivity, mood fluctuations, and overall functional recovery
In vivo study of naringin-loaded biomaterials patch coupled with biosensors for diabetic foot ulcer management
Full text linkBackground: Diabetic foot ulcers (DFUs) are a severe complication of diabetes, often leading to prolonged hospitalizations and even amputations. The need for advanced, efficient treatments is critical, particularly in regions like Indonesia, where healthcare resources are limited. In this study, naringin, a bioactive flavonoid renowned for its antioxidant and anti-inflammatory properties, was embedded within a biocompatible matrix of alginate, mesoporous silica, and polyvinyl alcohol.
Methods: This patch was engineered using electrospinning techniques, ensuring a controlled release of naringin to the wound site. To further advance this treatment modality, a colorimetric biosensor targeting uric acid a critical biomarker of wound severity was seamlessly integrated into the patch. In vivo studies were conducted using diabetic mouse models to assess the patch's efficacy in promoting wound healing.
Results: The results were promising: the naringin-loaded patches significantly accelerated wound closure and improved tissue regeneration compared to standard treatments. However, while the concept of integrating biosensors showed promise, the biosensor component in this study did not perform optimally and requires further refinement. The current iteration of the biosensor provided limited real-time monitoring capability, indicating the need for enhanced sensitivity and reliability for the application in the wound environment. This study highlights the potential of naringin-infused biomaterials as a therapeutic option for DFU treatment and underscores the importance of ongoing research to optimize biosensor integration.
Conclusions: While the in vivo results are promising, the study calls for further development of biosensors to fully realize the potential of this combined approach in clinical settings
A retrospective analysis of the burden and treatment patterns of esophageal cancer over one year in a tertiary healthcare institution in the Western Himalayan region
Full text linkBackground: Esophageal cancer (EC) is a highly aggressive malignancy with a poor prognosis, particularly in advanced stages. By 2024, EC incidence is expected to increase by 63.5% over 2020. The objective of the study was to analyse the EC burden and treatment patterns in Dr. RPGMC, Kangra, Himachal Pradesh, Radiotherapy and Oncology Department, with a focus on palliative radiotherapy.
Methods: A retrospective analysis of 83 patients treated at our institute between 2023 and 2024 for esophageal cancer (7.9% of all new cases). Patients received treatment in two groups: palliative (n=34) and radical (n=49). Analysis was done on demographic, histopathological, cancer staging, and treatment modalities data. Self-expandable metallic stent (SEMS) implantation, palliative chemotherapy, or radiotherapy were all considered forms of palliative care. It was evaluated if palliative radiotherapy improved dysphagia.
Results: Almost 8% of all cancers were esophageal cancers. There were 30.1% women and 69.8% men, with an average age of 63.9±9.6 years. In 98% of cases, squamous cell carcinoma was found. Of the palliative patients, three had SEMS placement, nine had chemotherapy, and twenty-two had radiotherapy. Following radiotherapy, dysphagia improved in 63.6% of palliative cases, or 68% of cases. Alcohol consumption and smoking were prevalent among men (76%).
Conclusions: The study highlights the burden of EC and the importance of tailored treatment strategies. While radical treatment remains the preferred approach, palliative care plays a crucial role in symptom management for advanced cases (alleviating dysphagia, improving QOL)
Therapeutic outcome of saroglitazar, a peroxisome proliferator activated receptor α/γ agonist in diabetic and non-diabetic metabolic dysfunction associated steatotic liver disease
Full text linkBackground: Metabolic dysfunction associated steatotic liver disease (MASLD) is the most common cause of chronic liver disease (CLD)and its consequences throughout the world, more so in developed countries. It is more concerning in view of the lack of a definitive treatment. Aside from lifestyle changes and vitamin E, we are still looking for a drug that can improve outcome in this group of patients.
Methods: Authors evaluated the safety and effectiveness of saroglitazar in MASLD/MASH patients in this 48-week prospective observational study, with the primary goal of evaluating the therapeutic outcome of saroglitazar on the NAFLD fibrosis score (NFS) in both diabetics and non-diabetics. After receiving written informed consent from each patient, a total of 292 patients who met the inclusion criteria were enrolled. However, only 257 individuals completed the study. Eligible patients were put on saroglitazar 4 mg per day for 24 weeks and followed on an OPD basis for 48 weeks with special emphasis on NFS, BMI, HbA1c, lipid levels, and liver biochemistry. Authors observed a male dominance (61.9%), a significant improvement in lipid profile, liver biochemistry, HbA1c, NFS, and liver stiffness measurement (LSM), and also an improvement in BMI though not statistically significant. Authors did not observe any significant drug related adverse events during the treatment with saroglitazar.
Conclusion: In our study, saroglitazar at a dose of 4 mg per day for 24 weeks resulted in marked improvements in liver biochemistry, lipid profile, HbA1c, NFS, and LSM, in patients of MASLD/MASH in both diabetics and non-diabetics
Depression and coping strategies among haemodialysis patients of Bagmati Province, Nepal
Full text linkBackground: Haemodialysis is therapeutic procedure of purifying blood used for management of acute and chronic renal failure. Financial burden, dialysis and other treatment procedures also add as stressor among patients undergoing haemodialysis treatment. Depression is most frequent psychological problem reported by chronic kidney patients but is also underdiagnosed and underrated among them. The prevalence of depression is reported higher among chronic kidney patients undergoing dialysis treatment compared to general population with higher risk of deaths and hospitalization. This study aimed to assess the depression and coping strategies among haemodialysis patients of Bagmati Province.
Methods: Quantitative cross-sectional study design was used in this research to collect the data from 3 Haemodialysis Centre viz. Kathmandu, Chitwan and Manthali as it covered the haemodialysis patients from Bagmati province. 370 participants were selected from Bagmati province of Nepal via simple random sampling technique. Nepali language version of Hospital Anxiety and Depression Scale (HADS) and Brief COPE Inventory scale were used to measure the depression and coping mechanism among the respondents. The descriptive and inferential statistics was used for data analysis.
Results: Nearly two-fifths (38.6%) of the respondents showed the symptoms of depression followed by no depression (35.9%) and borderline depression (25.4%). There was significant association between level of depression and coping strategies.
Conclusions: The finding from the study highlight the high prevalence of depressive symptoms. There is significant association between level of depression and coping strategies indicating need for targeted mental health intervention including promotion of effective coping mechanism in the targeted population
Clinical studies and safety evidence for human consumption of Shilajit: a herbo-mineral compound with multifaceted health benefits
Full text linkShilajit is one of the ancient and traditional herbo-mineral compounds that has been used for multiple health benefits for centuries. It is associated with potent antioxidant and anti-inflammatory effects via modulation of signaling pathways such as NF-kB and Nrf2/HO-1. One of the main components of Shilajit, fulvic acid, is primarily responsible for its diverse health benefits. However, apart from fulvic acid, it also contains humic acid, trace elements, minerals and vitamins, making it a potent health supplement. Recently, there has been a notable increase in Shilajit consumption, resulting in a growing body of scientific evidence from in vitro, in vivo and clinical trials. However, most of the published literature on Shilajit has been limited, mainly emphasizing its history, origin, chemistry or summaries of preclinical research, without thoroughly exploring the mechanisms of action or discussing existing clinical evidence. Hence, this manuscript aims to specifically address this gap by focusing on the mechanisms of action of Shilajit identified in preclinical research and offering a comprehensive overview of various clinical studies and trials.
Exploring the phytochemical constituents of Aegle marmelos (bael) and their therapeutic potential against chronic diseases
Full text linkAegle marmelos (Bael), a highly esteemed plant in traditional medicine, is recognized for its remarkable therapeutic properties, attributed to its rich and diverse phytochemical composition. The plant contains bioactive compounds such as alkaloids, flavonoids, tannins, phenolic acids, coumarins and essential oils, which contribute to its pharmacological activities. These compounds exhibit potent antioxidant, anti-inflammatory, antidiabetic, antimicrobial, hepatoprotective and cardioprotective effects, positioning Bael as a promising natural remedy for managing chronic diseases. Bael has demonstrated significant efficacy in regulating blood glucose levels, enhancing insulin sensitivity and protecting pancreatic beta cells, making it an effective agent in diabetes management. Additionally, its strong antioxidant and anti-inflammatory activities are essential in combating oxidative stress and chronic inflammation, which are key drivers of metabolic and neurodegenerative disorders. Bael’s antimicrobial properties further expand its potential to address infections and gastrointestinal issues. However, the integration of Aegle marmelosinto mainstream medicine faces challenges, including variability in its phytochemical composition, lack of standardized formulations and insufficient clinical trials to validate its safety and efficacy. This review aims to comprehensively explore the phytochemical constituents of Aegle marmelosand their therapeutic potential, particularly against chronic diseases. By identifying research gaps and future directions, it seeks to support the development of Bael as a reliable, standardized and effective therapeutic agent for modern healthcare
Comparison of safety and efficacy of pantoprazole alone with pantoprazole plus amitriptyline in functional dyspepsia patients: a randomized control trial
Full text linkBackground: The term functional dyspepsia refers to ulcer-like symptoms in patients who lack overt gastro duodenal ulceration. Functional dyspepsia can be subdivided into: postprandial distress syndrome (PDS), epigastric pain syndrome (EPS), and based on the presence of symptoms related to meals. It is defined as the presence of one or more of the following: postprandial fullness, early satiation, epigastric pain or burning, and no evidence of structural disease. Pantoprazole alone is compared with pantoprazole plus amitriptyline to relieve dyspepsia symptoms in functional dyspepsia patients.
Methods: The study was a randomized, prospective, open label, comparative interventional study. The study was conducted in the Department of Pharmacology and Department of Gastroenterology and Hepatology at Dr. R.P.G.M.C. Kangra at Tanda Himachal Pradesh, India which is 700 bedded multispecialty tertiary health care from August 2023 to May 2024 and follow -up was done for 4 weeks after initiation of treatment, to compare the safety and efficacy of pantoprazole with pantoprazole plus amitriptyline in functional dyspepsia patients.
Results: In our study compared to pantoprazole group, pantoprazole plus amitriptyline group has statistically significant reduction in all the 3 scores viz. Glasgow dyspepsia severity score (GDSS) (4.26±1.14 versus 3.3±1.37, p=0.002), short form leads dyspepsia questionnaire (SF-LDQ) (4 [3-5] versus 3 [2-4], p=0.005), and visual analogue pain score (VAS) (1 [1-2] versus 1 [0-1], p=0.0009).
Conclusions: The combination of pantoprazole and amitriptyline was more effective than pantoprazole alone in improving symptoms of functional dyspepsia, with no significant safety concerns