International Journal of Basic & Clinical Pharmacology
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A prospective, randomized, open-label study to compare the different dosage forms of omega 3 fatty acids as an adjuvant in the bipolar depression
Get PDFBackground: Bipolar affective disorder is a chronic disorder in which bipolar depression (BD) has poor prognosis than mania. There is a lack of universal pharmacotherapy for BD, with standard drug therapy having multiple long term adverse effects. Omega-3 fatty acids (O3FAs) act on key BD pathology and found to have reduction on symptom severity in BD. Thus, this study aims to compare efficacy and safety of 2 different doses, 1.2 g/day and 2.4 g/day of O3FAs with control group in BD patients.
Methods: This is an interventional, randomized, open-label, prospective and parallel study of 12 weeks with patients (n=90) randomly divided into three groups. This study compared the control group (Group A, n=30) on standard drugs only, with 1.2 g/day OD of O3FAs (Group B, n=30) and 2.4 g/day BD of O3FAs (Group C, n=30). Evaluation of efficacy was done on basis of Hamilton Depression Rating Score (HAM-D), Montgomery-Asberg Depression Rating Scale (MADRS), Clinical Global Impression (CGI) scales every 15 days for 3 months. Adverse effects were reported every 15 days for 3 months.
Results: After 3 months of treatment, Group C had statistically significant improvement in HAM-D (p<0.01), MADRS (p<0.01) and CGI (p<0.01) scores as compared to group A and B. Group A (37) had of adverse effects than Group B (21) and C (17) at 3 months.
Conclusions: Group C seems to had better efficacy and safety as compared to Group B and baseline drugs alone. Further extensive research with large sample size and studies with longer duration are required to validate the role of O3FAs in BD
Knowledge, attitude, and practice towards national health programs among MBBS students in a tertiary care centre of north India: a cross-sectional study
Get PDFBackground: National health programmes (NHPs) are pivotal to India’s public health strategy, and medical graduates are expected to understand and implement them effectively. However, undergraduate training may not uniformly equip students with the necessary competencies. This study aimed to assess the knowledge, attitude, and practice (KAP) regarding NHPs among MBBS students at different academic levels.
Methods: A cross-sectional, questionnaire-based study was conducted among 489 MBBS students (3rd year, final year, and interns) in three months from March 2025 to May 2025 at a tertiary care medical college in north India. A self-designed, structured and validated KAP questionnaire covering 10 knowledge items, 10 attitude statements, and 10 practice-related questions was administered. Descriptive statistics for comparative analysis, and results were visualised through line graphs and box plots.
Results: Knowledge and practice scores improved with academic progression, with final-year students scoring the highest (mean knowledge score: 4.82±1.75; practice: 6.73±2.47). Attitude scores remained uniformly positive across all groups (mean range: 1.99-2.09). Third-year students had the lowest knowledge and practice scores. Analyses revealed the presence of low outliers in all three domains, more prominent in junior batches. Overall, awareness of programs like Ayushman Bharat, NTEP, and eSanjeevani was relatively high, while misconceptions remained regarding schemes like PM-JAY and ABDM.
Conclusions: While attitudes toward NHPs were consistently favourable, knowledge and practice varied by academic year. The study underscored the need to integrate program-based learning and community engagement activities earlier in the undergraduate curriculum to strengthen public health readiness among future doctors
Comparative effectiveness and safety of cariprazine and lamotrigine in patients of bipolar depression: a prospective, randomized and open label study
Get PDFBackground: Bipolar disorder is marked by significant shifts in mood, energy, and behaviour. Cariprazine, a D3/D2 (dopamine) partial agonist, was FDA-approved in 2019 for treating bipolar depression, though clinical trial results have been mixed. Given this variability, the present study compared the effectiveness and safety of cariprazine monotherapy with lamotrigine in patients with bipolar depression.
Methods: Study was conducted for a total duration of 90 days comprising of 70 patients form either sex (18-65 years), diagnosed with bipolar depression. Patients were randomized into group A and group B homogenously. Group A patients were given cariprazine monotherapy at 1.5 mg/day, which was increased to 3 mg/day on day 31st. Similarly, for group B, lamotrigine monotherapy was administered at 50 mg/day and the dose was increased to 100 mg/day on day 31st.
Results: Treatment significantly lowered MADRS in intra and intergroup comparison (p<0.001). However, the p values differed for different time points on assessment of CGI-I despite being statistically significant (p<0.05; p<0.001). The prevalence of substance abuse in was reported to be 25%. SDS-S results for substance use were non-significant (p>0.05). Group B reported more adverse events than group A.
Conclusions: Cariprazine led to faster and greater reduction in depressive symptoms than lamotrigine in bipolar I depression. Both were well tolerated with similar safety profiles. Substance use was low in both groups, with slightly better improvement in dependence scores seen with cariprazine.
Enhancing ethical standards: a quantitative analysis of knowledge improvement a through structured good clinical practice workshop
Get PDFBackground: Good clinical practice (GCP) is an internationally recognized ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. In India, postgraduate medical students are mandated to take part in research projects as part of their academic curriculum, but a lack of training leads to considerable disparity in their understanding of GCP principles. A structured educational intervention like the GCP workshop helps in filling these disparities and promotes the conduction of ethical research.
Methods: An educational interventional study was conducted to assess the impact of a GCP workshop on knowledge among postgraduate medical students during a one-day GCP workshop at a tertiary care teaching hospital. A total of 163 students participated in the study. A self-developed, pre-validated questionnaire was used to assess the impact of knowledge before and after the workshop. Data was collected using Google forms and analysed by using Microsoft Excel and Jeffreys’s Amazing Statistics Program (JASP) software.
Results: Out of 163 participants, 158 postgraduate students completed both pre- and post-tests. The mean pre-test score was 22.3±3.5, which increased to 24.5±0.9 in the post-test. To assess the normality of data distribution, the Shapiro-Wilk test was performed and resulted in p<0.001, indicating the use of a nonparametric test. Then the Wilcoxon signed-rank test was performed, and results indicated statistically significant improvement (Z=7.48, p<0.001). Question-wise analysis revealed an increase in accuracy from 87.06% to 98.36%, indicating improvement in knowledge across the questionnaires.
Conclusions: The overall findings suggest that a structured good clinical practice (GCP) workshop plays a significant, important role in enhancing knowledge among postgraduate medical students
Comparative study of efficacy and safety of berberine hydrochloride versus metformin in newly diagnosed prediabetic patients: a randomized clinical trial
Get PDFBackground: Prediabetes is a growing public health concern in India, with high rates of progression to type 2 diabetes and associated complications. Metformin is widely recommended but has gastrointestinal side effects that may limit adherence. Berberine hydrochloride, a plant-derived alkaloid with antidiabetic properties, has shown promise as an alternative therapy. A randomized, open-label, parallel-group clinical trial was conducted in newly diagnosed prediabetic adults.
Methods: Ninety participants were randomly allocated to receive Berberine HCl 500 mg twice daily or Metformin 500 mg twice daily for 12 weeks. Primary outcomes included change in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), and HbA1c. Secondary outcomes included adverse events.
Results: Berberine HCl reduced mean FPG from 109.8±4.6 mg/dl to 97.2±3.6 mg/dl (−12.6±2.4 mg/dl) and PPG from 156.4±6.8 mg/dl to 134.6±5.4 mg/dl (−21.8±3.9 mg/dl). Metformin reduced FPG from 110.2±4.8 mg/dl to 99.4±3.8 mg/dl (−10.8±2.5 mg/dl) and PPG from 157.1±7.0 mg/dl to 137.8±5.6 mg/dl (−19.3±4.0 mg/dl). HbA1c decreased by 0.31% in the Berberine group and 0.28% in the Metformin group, with a significant between-group difference at week 12 (p=0.04). Gastrointestinal upset occurred in 20% of Berberine recipients compared to 30% in the Metformin group.
Conclusions: Berberine HCl demonstrated glycemic efficacy comparable to Metformin in prediabetic patients, with fewer gastrointestinal adverse events, suggesting its potential as an alternative therapy for individual’s intolerant to Metformin
Unraveling Iris ensata Thunb: a pharmacognostical, physicochemical and HPLC-assisted phytochemical investigation
Get PDFBackground: Iris ensata Thunb, commonly known as the Japanese iris, is a species of flowering plant in the Iris family (Iridaceae). Native to Japan, China, Korea, and Russia, it thrives in wetland environments and is often found near ponds and streams.
Methods: To standardize the test drug, various analytical techniques were employed, including organoleptic evaluation, extractive value determination, ash content analysis, phytochemical screening, elemental analysis, fluorescence study, and HPLC profiling.
Results: The findings revealed that the total ash content was 6.98%, while the water-soluble and alcohol-soluble extractive values were 13.3% and 9.81%, respectively. The loss on drying was recorded at 4.21%, foreign matter was 0.66% and the bulk density was found to be 0.63%. The HPLC analysis displayed 18 peaks, with peak 02 and peak 03 being the most significant, showing area concentrations and retention times of 54.676% at 2.828 minutes and 43.822% at 3.051 minutes, respectively.
Conclusions: This study provided essential reference data for ensuring the quality, purity, and identification of future batches of I. ensata Thunb contributing to its standardization in medicinal applications
Antifungal and antibacterial activities of Usnea lichen extracts and associated Endolichenic fungi from the Western Ghats, India
Get PDFBackground: Lichens of the Usnea genus and their associated Endolichenic fungi from biodiversity hotspots like the Western Ghats, India, represent underexplored sources of secondary metabolites with antimicrobial potential. This study evaluates the antifungal activity of Usnea extracts and antibacterial efficacy of Endolichenic fungi to address the surge in antimicrobial resistance, demanding novel bioactive agents.
Methods: Usnea species (U. subsordiata, U. perplexans, U. spinocula, U. undulata, U. maculata) were collected from Kodayar, Tamil Nadu and extracted sequentially with methanol, acetone and diethyl ether. Antifungal minimum inhibitory concentrations were determined by performing broth macrodilution against Aspergillus niger, A. flavus, Fusarium oxysporum, and F. solani. ELF were isolated from U. perplexans thalli, cultured and their ethyl acetate extracts tested for antibacterial activity using agar well diffusion against Staphylococcus aureus, Bacillus subtilis, Klebsiella pneumoniae and Escherichia coli.
Results: U. subsordiata extracts exhibited the strongest antifungal activity (MICs 93.72–109.34 µg/ml), while U. maculata showed the weakest (234.375–531.25 µg/ml). ELF isolates (Acremonium lichenicola, Aspergillus spp., Fusarium spp., Penicillium spp.) demonstrated broad-spectrum antibacterial effects, with Aspergillus spp. yielding the largest zones of inhibition, particularly against Gram-positive bacteria. Significant variations were confirmed by two-way ANOVA (p<0.001).
Conclusions: Usnea lichens and ELF harbor potent antimicrobial compounds, offering viable alternatives against antimicrobial resistant pathogens and emphasising the need for conservation and further metabolite characterization
Investigation of the hepatoprotective potential of the hydroalcoholic leaves extract of Ricinus communis on isoniazid induced and thioacetamide induced hepatotoxicity in Wistar rats
Get PDFBackground: The liver is highly susceptible to drug- and chemical-induced injury. Isoniazid and thioacetamide are known hepatotoxins that cause oxidative damage. R. communis leaves possess bioactive compounds with reported antioxidant and hepatoprotective potential. This study evaluated the hydroalcoholic leaf extract of R. communis against isoniazid and thioacetamide induced hepatotoxicity in Wistar rats.
Methods: Wistar rats were divided into five groups in each model. Each group consisted of five animals. Hepatotoxicity was induced using isoniazid (250 mg/kg, p.o., 14 days) and in another model using thioacetamide (400 mg/kg, i.p., 3 days). Test groups received R. communis extract at 250 and 500 mg/kg, with Liv.52 (400 mg/kg) as standard. Serum hepatic markers, body weight, liver-to-body weight ratio, and liver histology were assessed. Antioxidant activity was determined by ferric reducing antioxidant power assay. Data were analyzed using one-way ANOVA followed by Tukey’s test.
Results: In the isoniazid model, RIC 250 mg/kg and 500 mg/kg significantly reduced ALT levels (p<0.05), however at 500 mg/kg, the extract increased AST and ALP levels. The liver-to-body weight ratio decreased significantly in treatment groups. Histology revealed minimal hepatic changes compared to moderate-to-severe injury in controls. In the thioacetamide model, R. communis produced mild biochemical improvement but caused mortalities in both dose groups. FRAP assay confirmed antioxidant potential (EC₅₀=12.39 µg/ml).
Conclusions: R. communis extract demonstrated significant hepatoprotective and antioxidant activity, particularly at 250 mg/kg. However, the inconsistent effects at a higher dose and observed mortalities in the TAA model necessitate further investigation into its safety and therapeutic window
Adverse drug reactions: a prospective observational study at a tertiary care hospital
Get PDFBackground: Reporting and assessing adverse drug reactions is essential for regulators to monitor, research and maintain patient safety. The main purpose of this study was to report, assess the adverse drug reactions and its incidence at a tertiary care hospital.
Methods: This was a prospective observational study conducted in a tertiary care hospital in Bengaluru. A total of 184 suspected adverse drug reactions were recognized and documented during the study period of six months. After data collection, each suspected adverse drug reactions were assessed.
Results: The suspected adverse drug reactions were reported and evaluated from 178 patients. Among them, 60.11% were adults and 35.39% were elderly patients. The majority of patients were females (55.98%) followed by males (44.02%). A higher number of adverse drug reactions was reported from the general medicine department (48.37%). The majority of the route of administration of suspected drugs was through the oral route (54.31%). Most of the Adverse drug reactions outcome were recovered/resolved (57.60%). The severity of the majority of ADRs was moderate (77.17%). According to causality assessment, most of the ADRs were probable (75%) and were classified as type A (54.34%) reactions. The incidence rate of ADRs during the study period was 0.93%.
Conclusions: The study results indicate a significant decrease in the occurrence of adverse drug reactions compared to previous year. This reduction highlights the need for enhanced monitoring, improved drug safety measures and more effective ADR reporting. This investigation draws attention to ADR reporting practices and highlights the need for a more organized approach to ADR detection and management in hospitals
Educational outcome of inquiry-based teaching learning method versus traditional learning among second phase medical students in pharmacology
Get PDFBackground: Pharmacology is a core discipline in medical education, bridging basic and clinical sciences. Traditional lecture-based teaching promotes factual recall but may not sufficiently develop analytical and problem-solving skills. Inquiry-based teaching-learning (IBTL) emphasizes critical thinking, active participation, and self-directed learning.
Methods: A prospective, cross-sectional educational intervention was conducted among 92 phase-II MBBS students of Nagaon Medical College, Assam. Students were divided into group A (IBTL) and group B, traditional teaching method (TTM). Identical topics were taught in both groups. Assessment included pre- and post-tests, student feedback, and faculty perception. Data were analyzed using paired and unpaired t tests (SPSS v21).
Results: IBTL produced significant improvement in post-test scores (p<0.001) and led to higher student engagement and satisfaction. Faculty feedback reflected 100% agreement that IBTL enhanced conceptual understanding and critical thinking. Although traditional teaching yielded higher factual recall for the topic “vitamins” (p=0.004), IBTL supported better long-term retention, motivation, and deeper understanding.
Conclusions: IBTL is more effective than traditional methods in promoting active learning, conceptual clarity, and critical thinking. A blended model combining both approaches is recommended for optimal pharmacology education.