International Journal of Basic & Clinical Pharmacology

Polyaminoacid: revolutionizing drug delivery through advanced nanocarrier systems

Navneet O. Soni — Fri, 22 Aug 2025 00:00:00 +0530

Polyaminoacid are smart nanocarriers and striking aspirant material for drug delivery. Amino-acids can be effortlessly ionized positively or negatively. Commonly used polyaminoacid chains are polylysine, polyarginine, and polyglutamic acid. Polyaminoacid polymers can also be synthesized in the laboratory and are called synthetic polyaminoacid polymers. Polyaminoacid are sensitive to acidic pH and are degraded by acid and enzymes in the lysosome, the amino acids are released and the conjugated drug portion is also released. Block polymers are versatile and multifunctional in drug delivery. PEG-copolymers can be utilized for drug targeting, organ imaging and drug delivery purpose. Only water soluble polyaminoacid can be utilized for drug delivery and other biomedical applications. The advantage of using Polyaminoacid is that they are biocompatible, biodegradable, pH sensitive, provide nutrients to the tissue upon cleavage, are conjugated with drug, proteins, and antibodies, and can be amalgamated with other polymers such as chitosan, nanoparticle synthesis with other composite material is possible. The active drug loading is highly efficient, intracellular drug delivery possible, it can cross many physiological and anatomical barriers such as the blood brain barrier, self –assembled property, delivery of prodrugs etc. Biomedical applications include cancer cell targeting, gene transfer, gene delivery, siRNA transfer, miRNA, gene silencing, intraocular delivery, intracellular delivery, brain delivery, radiological imaging, bone tuberculosis, cosmetic use, colonic drug delivery, delivery of prodrug. Therefore, polyaminoacid are versatile in drug delivery systems.

Landiolol in supraventricular tachycardia: an updated review of clinical applications

Fri, 22 Aug 2025 00:00:00 +0530

Supraventricular tachycardia (SVT) is a prevalent cardiac arrhythmia requiring rapid and effective intervention. Landiolol, a highly selective, ultra-short acting, beta-1 adrenergic receptor blocker, has recently received FDA approval for short-term ventricular rate control in adults with SVT, including atrial fibrillation and atrial flutter. Its rapid onset and hemodynamic stability make it a valuable addition to acute cardiac care. Data from clinical trials, systematic reviews, and real-world studies were analyzed to evaluate landiolol’s role in SVT management. It effectively controls the ventricular rate in SVT. The drug exhibited a favourable safety profile and is better suited for rate control rather than arrhythmia termination when compared to adenosine. Its utility in managing perioperative atrial fibrillation, critically ill patients, and those with respiratory conditions makes it a valuable therapeutic option. Future research should explore its role in Indian demographics to optimize its clinical use.

Unveiling the science of drug development: strategies, successes, and challenges

M. Shakir Hussain, Ajit Kumar Mishra, Rishabh Pandey — Fri, 22 Aug 2025 00:00:00 +0530

This abstract provides an in-depth exploration of drug development, from historical perspectives to modern challenges and emerging trends. It begins by tracing the evolution of drug development over centuries, highlighting the pivotal role of pharmacy and regulatory oversight. The abstract emphasizes the multifaceted nature of drug development, involving collaboration across scientific disciplines and various stages, from preclinical to post-market monitoring. The challenges inherent in drug development, such as high costs, lengthy timelines, and regulatory hurdles, are thoroughly examined. Despite these challenges, the abstract underscores the importance of drug development in addressing unmet medical needs and improving public health. Furthermore, the abstract delves into specific aspects of drug development, including preclinical research and discovery, clinical trial methodologies, and successes and challenges in the field. It also discusses emerging trends, such as precision medicine, digitalization, and the role of artificial intelligence and machine learning. Overall, this abstract provides a comprehensive overview of drug development, highlighting its significance, challenges, and future directions in advancing healthcare.

Outcome measures for determining treatment efficacy in radiculopathy

Shamna K., Manju C. S. — Fri, 22 Aug 2025 00:00:00 +0530

Radiculopathy is a neurological disorder caused by any pathology affecting the nerve roots of peripheral nerve system, commonly manifested by pain, paresthesia and motor weakness. Lumbosacral radiculopathy, commonly referred to as low back pain, and cervical radiculopathy, referred to as neck pain, are the two most common forms of the condition. Although one of the main goals of treatment is pain alleviation, this does not always indicate that a patient has entirely recovered. Even after their pain subsides, many patients still struggle with everyday activities and emotional wellbeing. Patient reported outcomes are therefore used to determine if the treatment is effective in terms of functional quality of life of the patient. There are several scales and questionnaires available to evaluate pain and functional disability in both cervical and lumbar radiculopathies. By using these measures, efficacy of treatment may be evaluated more precisely and patient care is enhanced.

Comprehensive review of osteoarticular tuberculosis: from epidemiology to emerging therapies

Fri, 22 Aug 2025 00:00:00 +0530

Osteoarticular tuberculosis (OATB) remains a significant global health challenge with high morbidity and potential for permanent disability. Recent advancements in diagnostics, pharmacotherapy, and adjunctive treatments have shown promise for improving the outcomes of patients with OATB. This review summarizes the latest developments in the field, focusing on epidemiology, pathogenesis, diagnostic innovations, novel anti-tuberculosis drugs, combination therapy approaches, surgical interventions, adjunctive therapies, and the importance of multidisciplinary approaches. Emerging diagnostic technologies such as advanced imaging modalities, molecular assays, and nanotechnology-based tests have enhanced the speed and accuracy of OATB detection. Newer anti-tuberculosis drugs, including bedaquiline, delamanid, and pretomanid, have demonstrated efficacy in multidrug-resistant (MDR) and extensively drug-resistant (XDR) cases, whereas DprE1 inhibitors and oxazolidinone alternatives show promise in early phase trials. Minimally invasive surgical techniques, joint-preserving procedures, and reconstructive methods using 3D-printed implants and antibiotic-loaded materials have improved functional outcomes. Immunomodulators, bone grafts, and regenerative medicine have been explored as adjunctive therapies. Effective management of OATB requires collaboration among various specialists, and integrated care models facilitate personalized treatment plans. Challenges remain, including drug resistance, and the need for further research to establish optimal regimens and durations specific to OATB. By highlighting key advancements and their potential impact on patient outcomes, this review underscores the importance of a multidisciplinary evolving paradigm for treating OATB in the era of precision medicine.

Fluoroquinolone-nitro imidazole fixed-dose combination medication-induced fixed drug eruption with positive re-challenge

Debjyoti Halder, Indrani Dalal, Durbashree Das — Fri, 22 Aug 2025 00:00:00 +0530

Fluoroquinolone-nitroimidazole fixed-dose combinations, such as ofloxacin-ornidazole and norfloxacin-tinidazole, are widely prescribed for gastrointestinal infections. However, fixed drug eruptions (FDEs) associated with these combinations are underreported. A 32-year-old female developed generalized itching and painful ulcerative lesions on the buccal mucosa shortly after taking an ofloxacin-ornidazole tablet. Upon discontinuation and substitution with norfloxacin-tinidazole by a physician, her symptoms worsened, indicating a positive rechallenge. Dermatological evaluation led to withdrawal of the drug and initiation of antihistamines and topical analgesics, resulting in symptom resolution. Her clinical course, including lesion recurrence at the same site upon re-exposure, confirmed the diagnosis of FDE, a delayed-type hypersensitivity reaction mediated by CD8+ T cells. Causality assessment using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale classified the reaction as certain. This case highlights the need for thorough drug history taking and the importance of avoiding re-prescription of drugs from the same pharmacological class in patients with suspected drug allergies.

Acute generalized exanthematous pustulosis induced by flupentixol-melitracen: a previously unreported drug reaction

Dipanjan Das, Lairenjam Teza, Asok Gangopadhyay — Fri, 22 Aug 2025 00:00:00 +0530

Acute generalized exanthematous pustulosis (AGEP) is a rare and severe cutaneous drug reaction, most often triggered by antibiotics or antifungals. Psychotropic medications are an uncommon cause. We report the case of a 60-year-old male who developed AGEP within 24-48 hours of initiating flupentixol-melitracen, a fixed-dose antipsychotic-antidepressant combination. Clinical features included widespread sterile pustules on an erythematous base, and histopathology confirmed the diagnosis. The eruption resolved rapidly upon drug withdrawal and topical corticosteroids. To the best of our knowledge, this is the first reported case of AGEP induced by flupentixol-melitracen. Clinicians should consider this rare association when evaluating drug-induced pustular eruptions.

Improvement of schizoaffective disorder with endoxifen treatment: a case report

Shvetha Chilukuri — Fri, 22 Aug 2025 00:00:00 +0530

Schizoaffective disorder shares symptomatology and pathophysiology with schizophrenia and bipolar disorder. Studies related to treatment option and their efficacy in schizoaffective disorder are limited; thus, no current consensus treatment guidelines exist. Patients with schizoaffective disorders are treated mainly with combination of antipsychotics and mood stabilizers or antidepressants. Here, the author presents a case of schizoaffective disorders that was successfully treated with endoxifen, which had efficacy issues with amisulpride, quetiapine, and risoperidone and safety issues with clozapine.

Comparison of safety profiles of DPP-4 inhibitors with SGLT-2 inhibitors in type 2 diabetes mellitus: a systematic review

Zeel R. Nimavat, Ankit N. Patel, Alpa P. Gor, Barna Ganguly — Tue, 29 Jul 2025 00:00:00 +0530

In type 2 diabetes mellitus (T2DM), add-on therapy to metformin is often required. Both sodium-glucose cotransporter-2 (SGLT2) inhibitors and dipeptidyl peptidase-4 (DPP-4) inhibitors are widely used, but differ in their safety profiles due to distinct mechanisms of action. This study aimed to systematically review and compare the safety outcomes of SGLT2 versus DPP-4 inhibitors in patients receiving background metformin therapy. A systematic literature search was conducted in PubMed for studies published from 2006 onward. Randomized controlled trials and observational studies evaluating safety outcomes of SGLT2 inhibitors (empagliflozin, dapagliflozin, canagliflozin) and DPP-4 inhibitors (sitagliptin, teneligliptin, vildagliptin) as add-on to metformin were included. Data on adverse events (AEs), serious adverse events (SAEs), and drug-related adverse events (DRAEs) were extracted and analyzed. Twenty studies met the inclusion criteria: 8 studies on SGLT2 inhibitors (n=946) and 12 on DPP-4 inhibitors (n=1903). The overall incidence of AEs was higher with DPP-4 inhibitors (66%) compared to SGLT2 inhibitors (34%), while DRAEs were comparable (12% vs. 11%). SGLT2 inhibitors were more often associated with genital and urinary tract infections, whereas DPP-4 inhibitors had higher rates of gastrointestinal disturbances and hypoglycemia. Rare events included dehydration and atrial flutter (SGLT2) and dyspepsia and hypertension (DPP-4). Notably, adverse events varied across individual agents within each class. Both SGLT2 and DPP-4 inhibitors demonstrate acceptable safety as add-on therapy to metformin. Given drug-specific adverse events, individualized therapy based on patient characteristics is essential. Further large-scale safety-focused studies are warranted.

Comparative effectiveness of oral antibiotic regimens for urinary tract infections in outpatients: a systematic review

Mehnaz Hoda, Sabir Amin Ahmad, Afreen Hoda — Fri, 22 Aug 2025 00:00:00 +0530

Urinary tract infections (UTIs) are one of the most prevalent bacterial infections encountered in outpatient clinical practice, especially among women. The treatment of uncomplicated UTIs predominantly involves oral antibiotic therapy; however, the increasing prevalence of antimicrobial resistance presents a significant challenge in selecting the most effective regimen. This systematic review critically evaluates and compares the effectiveness and safety of various oral antibiotic regimens used for the treatment of uncomplicated UTIs in outpatient populations. The study synthesizes evidence from randomized controlled trials (RCTs), cohort studies, and observational studies to identify antibiotics that provide superior symptom resolution, microbiological cure, and lower recurrence rates, while considering patient demographics, local antimicrobial resistance patterns, and adverse effect profiles. The findings suggest that fluoroquinolones, particularly norfloxacin and ofloxacin, demonstrate lower treatment failure rates compared to trimethoprim-sulfamethoxazole (TMP-SMX) and ciprofloxacin. However, the review also emphasizes the need for caution in the use of fluoroquinolones due to their associated side effects and rising resistance. This study aims to guide clinicians in making evidence-based antibiotic choices to optimize patient outcomes and support antimicrobial stewardship efforts in outpatient care.

Carbapenem resistance crisis: a retrospective investigation of gram-negative bacterial isolates in a tertiary care hospital in Egypt

Fri, 22 Aug 2025 00:00:00 +0530

Background: The increasing prevalence of carbapenem-resistant gram-negative bacteria poses a significant threat to public health worldwide. This study aimed to investigate the patterns and determinants of carbapenem resistance among gram-negative bacterial isolates from patients admitted to Tanta University Chest Hospital, Egypt.

Methods: A retrospective, observational study was conducted, involving patients who received carbapenem antibiotics (ertapenem, imipenem, or meropenem) for at least 48 hours during their hospitalization between January 1, 2023, and December 31, 2023. Data on patient demographics, duration and indication of use and microbiological data were collected. Carbapenem resistance was assessed using antimicrobial susceptibility testing.

Results: A total of 80 patients with gram-negative bacterial cultures were included in the study. The overall prevalence of carbapenem resistance was 70%. No significant associations were found between carbapenem resistance and gender, age or indication. However, significant differences in resistance rates were observed among bacterial species. Acinetobacter (87%), Klebsiella (82%), and Pseudomonas (78%) exhibited high probabilities of carbapenem resistance, while E. coli had a lower resistance rate (31%). Logistic regression analysis confirmed that E. coli was significantly less likely to be resistant to carbapenems compared to Pseudomonas (p=0.039, OR=0.127, 95% CI: 0.018-0.905).

Conclusions: The study revealed an alarmingly high prevalence of carbapenem resistance among gram-negative bacterial isolates in a tertiary care hospital in Egypt. Effective antimicrobial stewardship programs, strict infection control measures, and continuous surveillance of antimicrobial resistance patterns are crucial to combat the growing threat of carbapenem-resistant organisms.

Potential restorative effect of silymarin on liver histoarchitecture on paracetamol-induced in hepatotoxicity, in adult albino rats

Davis Kiprono Ngetich, Moly Okoth — Fri, 22 Aug 2025 00:00:00 +0530

Background: Paracetamol is one of the most common pain relievers you’ll find in any medicine cabinet. Worldwide its often used for fevers or everyday aches without a second thought. But while it’s generally safe, taking too much can seriously harm the liver, something many might not realize. Otherwise, natural remedies offer potential remedies like silymarin, an extract from milk thistle. This herbal compound isn’t just a supplement; studies suggest it fights oxidative stress and even helps repair damaged cells. Objective of this study was to determine the histo-restorative effects of different doses of silymarin milk thistle on liver histo-architecture on paracetamol-induced hepato-toxicity among adult albino rats.

Methods: A total of 24 rats, splitting them into four groups. One group got a high, toxic dose of paracetamol alone; another stayed untreated as a control. The remaining rats were all given paracetamol first to induce liver injury, then divided into three subgroups receiving low, medium, or high doses of silymarin. After the treatment period, their liver tissues were extracted and studied under a microscope, using standard staining techniques to assess any recovery.

Results: High dose of paracetamol induced liver toxicity. Upon administration of high dose of silymarin milk thistle, there was histo-restoration of liver architecture with evenly distribution of hepatocytes and reduction and vacuolation of the central vein in relation to the control group.

Conclusions: These findings showed that high dose (600 mg/kbwt) of silymarin milk thistle was found to have restorative effects and restored the liver histo-architecture to near normal.

High levels of cardiac and oxidative stress biomarkers ameliorated following treatment with aspirin, vitamin C, and Justicia secunda hydromethanol leaf extract on epinephrine induced-myocardial infarction in male Wistar rats

Fri, 22 Aug 2025 00:00:00 +0530

Background: Myocardial infarction is an increasing cardiac disorder globally. This study investigated the ameliorative potentials of Justicia secunda hydromethanol leaf extract on epinephrine-induced myocardial infarction in male Wistar rats.

Methods: Twenty-four rats weighing (70-170 gm) were assigned into 6 groups (n=4). Group A was control, group B received epinephrine (0.08 mg/kg) intraperitoneally for 2 days; groups C-F received epinephrine followed by oral treatments: Aspirin (2 mg/kg), Justicia secunda (1 mg/kg), Justicia secunda (2 mg/kg) and vitamin C (2 mg/kg) respectively for 14 days.

Results: There was a significant elevation of lactate dehydrogenase and troponin T and disruption in electrolyte balance, indicative of myocardial injury. Treatment with Justicia secunda (2 mg/kg), aspirin, and vitamin C significantly reduced LDH and troponin T levels (p<0.01), improved antioxidant status (increased SOD, CAT, GSH; decreased MDA), and slightly normalized electrolytes. Justicia secunda (2 mg/kg), exhibited improvement in high-density-lipoproteins and reduction in low-density-lipoprotein levels.

Conclusions: Treatment with Justicia secunda (particularly at 2 mg/kg), aspirin, and vitamin C ameliorated the epinephrine-induced myocardial infarction. Hence, if these results apply to humans, using Justicia secunda in management of myocardial infarction and oxidative stress should be encouraged as a potential natural adjunct.

Effect on liver function of an ayurvedic medicine Punarnavasava after 28 days chronic toxicity studies on male Sprague Dawley rats

Fri, 22 Aug 2025 00:00:00 +0530

Background: Punarnavasava (PVR) is an ayurvedic formulation predominantly used as a traditional medicine in the rural population to get relief from edemic conditions. Though this medication is recognized as generally safe, clinical research on this formulation is scarce. Therefore, contributing to determining the safety of this drug may help ensure safer treatment for thousands of patients.

Methods: The effect of chronic administration of PVR on liver function was determined by administrating chronically to the male Sprague-Dawley rats at a dose of 40 ml per kg body weight for 28 days. In this experiment plasma protein, albumin, serum bilirubin and various serum enzymatic parameters were determined.

Results: In the study, the total protein content in the plasma was increased (11.05%) in the PVR treated male rats. The increase in total protein was not statistically significant but was noticeable (p=0.104). On contrary, the albumin content was decreased (7.92 %) in PVR treated male rats and it was not statistically significant, yet it was noticeable (p=0.076). No difference on the bilirubin level between the control and the experimental group was noted. In the PVR administered male rats, activities of alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), and alkaline phosphatase (ALK-P) was decreased by 31.90%, 45.44%, 82.82% and 32.53% respectively and all these changes were statistically very highly significant (p=0.0001) for all these enzymes. In contrast, a not significant negligible increment was observed in the GGT activity.

Conclusions: From this study, it is evident that there was no adverse increase in the liver function parameters in the male rats after chronic administration of PVR, on the contrary significant decrease in the serum liver function enzymes were noted, therefore, it can be concluded that this Asava preparation (PVR) can be administered chronically. With the slight increase in GGT though negligible suggests caution for use in pregnancy related edemic conditions which may deteriorate liver cholestasis related to later stage of pregnancy. Further research should be done to reconfirm the safety of this ayurvedic medicine in pregnancy.

Comparative evaluation of two prophylactic intravenous bolus doses of phenylephrine for prevention of spinal-induced hypotension in elective cesarean sections: a prospective and randomized study

Sushma Paccha, Amith Srisha, Raghavendra T. R. — Tue, 15 Jul 2025 00:00:00 +0530

Background: Hypotension is a common and clinically significant complication associated with spinal anesthesia during cesarean section, often persisting despite standard preventive strategies such as fluid preloading and left uterine displacement. Vasopressors like phenylephrine are routinely employed to counteract the hemodynamic instability, yet limited data exist comparing different fixed bolus doses of phenylephrine for prophylaxis against spinal-induced hypotension in obstetric anesthesia. This study aimed to evaluate and compare the efficacy and safety of two intravenous bolus doses of phenylephrine-150 micrograms and 200 micrograms-administered immediately following spinal anesthesia, in preventing maternal hypotension during cesarean delivery.

Methods: A prospective, randomized, double-blind study was conducted at Adichunchanagiri Institute of Medical Sciences, Karnataka, India involving 60 parturients scheduled for elective cesarean section. Group A received 150 µg and group B received 200 µg phenylephrine IV bolus immediately after spinal anesthesia. Hemodynamic parameters, incidence of hypotension and bradycardia, requirement of rescue boluses, and Apgar scores were recorded.
Results: The incidence of hypotension was 16.6% in both groups. Group B showed a significantly higher incidence of bradycardia (43.3%) compared to group A (20%, p<0.05). Group A demonstrated better hemodynamic stability with fewer rescue interventions. Neonatal outcomes were similar in both groups.

Conclusions: A 150 µg bolus of phenylephrine is as effective as 200 µg in preventing hypotension following spinal anesthesia in cesarean delivery, with fewer adverse effects. It is recommended as the preferred dose for prophylaxis.

Prescribing pattern and quality of life in patients with migraine at a tertiary care teaching hospital

Arthvi M. Amin, Alpa P. Gor, Soaham Desai, Barna Ganguly — Tue, 29 Jul 2025 00:00:00 +0530

Background: Migraine, a prevalent and disabling neurological disorder, affects over a billion people globally, with a significant impact in India. Despite effective treatments, poor adherence and limited data on drug use and quality of life persist, especially in developing nations. Understanding these patterns is crucial for enhancing patient care, optimizing healthcare resources, and reducing the socioeconomic burden of migraine.

Methods: This one-year prospective observational study was conducted at Shree Krishna Hospital, Gujarat, following ethical clearance. A total of 150 migraine patients diagnosed according to the ICHD-3 (International Classification of Headache Disorders, 3rd Edition) were enrolled. Data on demographics, treatment, and quality of life (via MIDAS [Migraine Disability Assessment] and MIBS-4 [Migraine Interictal Burden Scale]) were collected. Statistical analysis was conducted using STATA 14.2. Informed consent ensured participant confidentiality and adherence to research standards.

Results: Among 150 migraine patients (74.7% female), most had low-frequency episodic migraine with moderate throbbing pain. NSAIDs (mainly naproxen) and TCAs (mainly amitriptyline) were widely used. MIDAS showed 11.3% had severe disability; MIBS-4 revealed 24% experienced severe interictal burden. Sleep disturbance, stress, and anxiety were common triggers, highlighting migraine's multifactorial impact on daily routine affecting quality of life.

Conclusions: Although triptans have proven efficacy as acute treatment, their utilization remains limited. Quality of life assessments using MIDAS and MIBS-4 revealed significant disability, underscoring the need for enhanced management strategies targeting associated psychological conditions such as anxiety and depression. Optimizing prescription practices, improving patient education, and incorporating lifestyle modifications are crucial for effective long-term migraine management. These interventions promise improved patient outcomes.

Comparative study of efficacy and safety of berberine hydrochloride versus metformin in newly diagnosed prediabetic patients: a randomized clinical trial

Prashant S. Chaudhary, Shweta V. Deshmukh, Deepali Jaybhaye, Sukhmeen Kaur — Fri, 22 Aug 2025 00:00:00 +0530

Background: 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.

Formulation and nutritional evaluation of galactagogue-based nutritional health mixes to support lactation

Sanya Durrani, Netravathi Hiremath, Shweatha H. E. — Fri, 22 Aug 2025 00:00:00 +0530

Background: Human breast milk is a rich source of essential nutrients and also contains protective elements such as antibodies and immune factors, along with hormones, growth factors, enzymes, and other bioactive compounds, which are designed for easy digestion and optimal absorption, ensuring the best possible growth and development of infants. However, dysgalactia or insufficient milk production, often linked to inadequate intake of calories and essential nutrients necessary for milk production, is a common hindrance to breastfeeding. In this context, the current study was planned to design and develop different variations of finger millet and oats-based galactagogue health mixes with the intent to encourage milk synthesis.

Methods: Four galactagogue health mixes, namely GHM-R1, GHM-R2, GHM-O1 and GHM-O2 based on finger millet (25 and 50%) and oats (25 and 50%) with nuts and seeds, were developed. Foxnut flour-based health mix was used as a control. A descriptive sensory score card was used for sensory analysis. AOAC methods were used to analyse proximate and dietary fibre. Calcium and iron were analysed using standard protocols.

Results: Among the developed galactagogue health mixes, the sensory quality of GHM-R1 (25% popped finger millet) was found to be highly acceptable with a score of 8.45. GHM-R2 (50% popped finger millet) reported the highest calcium content, 328 mg/100 gm.

Conclusions: There lies great scope in scientifically evaluating the traditional knowledge systems based galactagogues for the mechanism, efficacy, dose, and safety.

ABC-VED matrix-a dual approach to efficient inventory control at a tertiary care teaching hospital in India

Aishwarya B. Kulkarni, Sujata Dudhgaonkar, Pravin Uike — Fri, 22 Aug 2025 00:00:00 +0530

Background: Inventory control is based on criticality criteria (VED) and on cost criteria (ABC). This underlines the need of strategically planning, creating, and arranging the pharmacy to ensure effective clinical and administrative services.

Methods: This retrospective observational cross-sectional study was conducted in the medical store of Government Medical College, Gondia, Maharashtra, over a one-year period (January-December 2023). A total of 142 drug items were analysed based on complete records of annual consumption and expenditure. ABC, VED, and ABC-VED matrix analyses were performed to categorize drugs. Data were analysed using Microsoft Excel 2019. Ethical clearance was obtained from the institutional ethics committee (approval number: 98/12/11).

Results: Category A drugs (26%) consumed 71.1% of the budget, indicating high expenditure on fewer items. Categories B and C accounted for 32.2% and 40.8% of items, with 22.8% and 6.1% expenditure respectively. VED analysis showed that vital drugs (29.5%) accounted for 24.8% of costs, essential drugs (51.2%) for 47.9%, and desirable drugs (18.3%) for 27.3%. The ABC-VED matrix revealed that category I drugs (47.88%) consumed 90% of the budget, highlighting the importance of monitoring high-cost and life-saving items.

Conclusions: ABC-VED needed to adopt as routine for optimal resource utility eliminates stock out situation in hospital medical store.

Demographic and clinical profile of functional dyspepsia patients in a Northern Indian tertiary care setting

Fri, 22 Aug 2025 00:00:00 +0530

Background: Functional gastrointestinal disorders (FGIDs) are prevalent and diagnostically challenging conditions that lack structural abnormalities, but significantly contribute to patient morbidity. This study aimed to analyze the demographic and baseline clinical parameters of patients presenting with functional dyspepsia symptoms in a tertiary care hospital in Northern India.

Methods: This analysis was based on baseline data from a randomized controlled trial involving 71 patients (aged 18–75 years) with non-structural gastrointestinal complaints. Prior to randomization and treatment initiation, all patients underwent complete blood count, liver and renal function tests, fasting blood sugar measurement, electrocardiography (ECG), upper GI endoscopy (UGIE) and Helicobacter pylori biopsy. Demographic and baseline clinical data were analyzed using descriptive statistics and comparative tests.

Results: The mean age of patients was 46.37±15.2 years, with the highest representation in the 51–60 years age group. Females predominated slightly (56.34%). All patients had normal UGIE and ECG findings and tested negative for Helicobacter pylori. Laboratory parameters were within normal limits for both sexes. Most patients had moderate gastrointestinal symptom scores before treatment, as assessed by GDSS, SF-LDQ and VAS scores.

Conclusions: Functional Dyspepsia is more common in middle-aged individuals and slightly more prevalent in females. Despite the absence of structural findings, symptom severity is considerable, necessitating a comprehensive assessment and individualized management strategies. This study provides valuable insights into the demographic and clinical characteristics of patients with FGID in a tertiary care setting in Northern India.

A prospective, randomized, open-label study to compare the efficacy and safety of metformin versus metformin and fluoxetine in patients of type 2 diabetes mellitus with mild depression

Deepali Aggarwal, Gurpreet Kaur Randhawa, Rakesh Chander — Fri, 22 Aug 2025 00:00:00 +0530

Background: Type 2 diabetes mellitus (T2DM) and depression often occur together, increasing morbidity and mortality. While metformin shows potential antidepressant effects, its comparative efficacy and safety versus metformin-fluoxetine (MF) combination in T2DM patients with mild depression required further study.

Methods: This prospective, randomized, open-label study involved 60 patients (18-65 years) with T2DM and mild depression (HDRS 8-13) over 90 days. Group A received metformin 500 mg twice daily (n=30), while group B received metformin 500 mg twice daily plus fluoxetine 40 mg daily (n=30). Primary outcomes included glycemic parameters (FPG, HbA1c) and depression scores (HDRS, CGI). Safety, quality of life, and compliance were also assessed.

Results: Baseline parameters were comparable between groups. Both groups showed highly significant improvements (p<0.001) in glycemic control and depression scores. Over 60 days, group A showed 20% HDRS improvement versus group B’s 10%; CGI-I was 3.33% in A versus 0% in B. By 90 days, HDRS improvement was 100% in group A versus 93.33% in B, while CGI-S and CGI-I improvements were 100% for both groups. No significant intergroup differences were observed for efficacy (p>0.05). Expected adverse effects were lower with metformin (28.33%) versus fluoxetine therapy (66.67%), all mild. Both groups demonstrated highly significant (p<0.001) QOL improvement and good compliance (≥85%).

Conclusions: Both treatments effectively improved glycemic control and depression symptoms. Metformin monotherapy demonstrated comparable efficacy and safety to the combination therapy of metformin and fluoxetine for managing mild depression in T2DM patients.

Physicochemical characterization of ferric carboxymaltose brands in India: relevance to anemia management in chronic kidney disease

Fri, 22 Aug 2025 00:00:00 +0530

Background: Ferric carboxymaltose (FCM) is widely used in the management of anemia associated with chronic kidney disease. The therapeutic efficacy and long-term safety of FCM related to free iron mediated toxicity can be influenced by its physicochemical properties. This study aimed to compare physicochemical properties across various FCM brands available in India.

Methods: Samples of FCM from 6 different manufacturers were procured including Dr. Reddy’s FCM brand injection Irny and subjected to a series of laboratory tests. Key quality attributes like carbohydrate content, molecular weight, etc. were analysed using validated methodologies and compared with USFDA reference-listed drug (RLD) Injectafer.

Results: The carbohydrate content of Dr. Reddy’s injection Irny (8.78%) was comparable to USFDA RLD (8.2%), whereas other brands showed variability ranging from 4.38% to 10.56%. Molecular weight of Irny (2.74 lakh) was also in line with USFDA RLD (2.94 lakh), with other brands mostly exhibiting lower molecular weights. Zeta potential of injection Irny (0.17 mV) closely matched that of USFDA RLD (1.25 mV), while other brands showed more negative values ranging from -0.70 mV to -27 mV. Degradation kinetics (T75 value) of injection Irny (19.14 minutes) were similar to USFDA RLD (18.34 minutes), while other brands demonstrated longer degradation times (21 to 52 minutes).

Conclusions: Study highlighted notable variability in physicochemical properties of different FCM brands. Dr. Reddy’s injection Irny closely aligns with the USFDA RLD Injectafer quality attributes, suggesting comparable potential clinical outcomes and long-term safety. The observed differences among other brands may influence their bioequivalence and long-term safety.

A comparative study of efficacy and safety of topical clindamycin 1% gel versus topical dapsone 5% gel in acne vulgaris over face: a prospective randomized double-blind study

Jyoti P. Gadhvi, Devendra S. Kushwah, Anubhav Garg, Seema Gogoi — Fri, 22 Aug 2025 00:00:00 +0530

Background: Acne vulgaris is a common chronic condition in both adolescents and adults. While 1% clindamycin gel is a standard topical treatment, increasing antibiotic resistance limits its long-term use. Dapsone 5% gel, with anti-inflammatory and antimicrobial properties, is a potential alternative. This study compared the efficacy and safety of 5% dapsone gel versus 1% clindamycin gel in mild-to-moderate acne.

Methods: This 12-month prospective, randomized, double-blind study was conducted at the dermatology OPD, J.A. Group of Hospital, Gwalior, from November 2023 to October 2024. Eighty patients with facial acne were equally randomized into two groups: group 1 received clindamycin 1% gel; group 2 received dapsone 5% gel. Treatment was applied once daily at night for 12 weeks. Efficacy was assessed at baseline and weeks 4, 8, and 12 using the investigator’s global assessment (ISGA) and total lesion count (TLC). Safety and adverse drug reactions (ADRs) were recorded. The Hindi version of the Cardiff acne disability index (CADI) assessed psychosocial impact.

Results: Both groups showed significant improvement by week 12. Final ISGA scores were similar (clindamycin: 1.189±0.397; dapsone: 1.184±0.392; p=0.913). Lesion count reductions were also comparable (p=0.148). Dapsone was more effective for inflammatory lesions- papules (p=0.001) and pustules (p=0.000). Comedone reduction, ADRs (p=0.555), and CADI improvements (p=0.213) were similar.

Conclusions: Dapsone 5% gel showed efficacy comparable to clindamycin 1%, with superior results for inflammatory lesions. Both were well tolerated and improved quality of life, making dapsone a promising alternative.

Potential concerns and challenges toward anti-SAR-CoV-2 vaccine among undergraduate students of North India

Rakhi Mishra, Hem Lata, Sonia, Santosh Kumar, Seeta Devi — Fri, 22 Aug 2025 00:00:00 +0530

Background: SARS-CoV-2 has trampled the healthcare system during the pandemic and still frames distressed pictures of quarantine, isolation, and vaccine hesitancy. Hence, the present study was conducted at a tertiary care hospital in Uttarakhand to address the paucity of data regarding concerns and challenges in accepting the anti-SAR-CoV-2 vaccine among medical and nursing students.

Methods: An online survey was conducted via the Google platform using Google forms. A total of 248 undergraduate medical and nursing students who were selected via the non-probability.

Results: The mean age was 22.0±3.6 years. Of them, 58% were B.Sc. nursing students, and 42% were MBBS/DNB students. About 85% agreed that the COVID-19 vaccine was safe and were psychologically prepared for minor signs and symptoms after vaccination. About 23% were worried about the hormonal changes that may occur after getting vaccinated. Nearly one third (37%) had concerns about hospital admission and expenses in case of any adverse events. Overall, 56% had accepted the SARS-CoV-2 vaccine.

Conclusions: Although the acceptance rate was high among participants, a few concerns and challenges reported by participants cannot be overlooked. Hence, there is a need to continuously address the concerns to improve the rate of adherence and to further psychologically prepared for the minor signs and symptoms after vaccination SARS-CoV-2.

Effectiveness, adverse drug reactions and adherence among hypertension patients in department of general medicine at Integral Institute of Medical Science and Research: a prospective observational study

Fri, 22 Aug 2025 00:00:00 +0530

Background: This study aimed to evaluate the drug effectiveness, adverse drug reactions and adherence among hypertensive patients. Additionally, we aimed to determine the clinical characteristics and the risk factors.

Methods: This six-month prospective observational study was jointly conducted by Integral University’s department of pharmacy and Medicine at Integral Institute of Medical Sciences and Research, Lucknow. The investigation involved 100 hypertensive patients from both inpatient (IPD) and outpatient (OPD) departments. Collected data were analysed through Microsoft Excel using descriptive statistical methods.

Results: The study population comprised 100 hypertensive patients (38 male, 62 female). Analysis showed 82% treatment efficacy, with telmisartan+amlodipine combination therapy achieving significant blood pressure reduction (11.7 mmHg). Notably, ADRs were monitored via active surveillance and patient interviews; suspected events were assessed using the Naranjo causality scale. Medication compliance reached 84%, particularly with once-daily regimens of amlodipine 5 mg and telmisartan 40 mg (marketed as Telvas/Telma). These findings demonstrate the clinical efficacy and safety profile of current antihypertensive protocols, emphasizing the importance of appropriate drug selection and dosing schedules.

Conclusions: The study confirmed the therapeutic effectiveness, strong adherence rates, and excellent safety profile of antihypertensive treatments, particularly telmisartan and amlodipine. These outcomes validate existing prescription patterns while providing real-world evidence for hypertension management strategies. Ongoing monitoring of treatment response and patient compliance remains crucial for maintaining optimal cardiovascular health outcomes.

Retrospective assessment of adverse drug reactions linked to first-line antituberculosis drugs at a tertiary healthcare facility in Northern India

Abhinandan Kumar, Ritu Yadav, Rakesh Chandra Chaurasia — Fri, 22 Aug 2025 00:00:00 +0530

Background: Tuberculosis (TB) continues to pose a major health challenge in India, where the burden remains among the highest globally. First-line anti-tubercular therapy (ATT), though effective, often leads to adverse drug reactions (ADRs) that may interfere with patient adherence and overall treatment success. This study aimed to assess the pattern and severity of ADRs associated with ATT in a real-world clinical setting.

Methods: This retrospective review analyzed 102 reports of adverse drug reactions (ADRs) submitted to the Pharmacovigilance Programme of India (PvPI). Data were obtained from the ADR Monitoring Centre at Motilal Nehru Medical College, Prayagraj. Although the data were collected between 2015 and 2018, the analysis was performed in 2025 to derive retrospective insights into ADR trends. Given the consistency of the standard ATT regimen over the years, the findings remain clinically relevant. The study evaluated types of ADRs, severity using the modified Hartwig and Siegel scale, and causality using WHO-UMC criteria. Statistical analysis was performed using SPSS version 25.

Results: Drug-induced hepatitis was the most frequently observed ADR (58.8%), followed by gastrointestinal symptoms (22.5%) and skin-related reactions (8.8%). Most ADRs occurred in male patients (63.7%) and during the intensive phase of ATT (73.5%). A significant correlation was noted between the type of ADR and the treatment phase (chi-square =56.29; p<0.001).

Conclusions: ADRs with first-line ATT are not uncommon, with liver toxicity being especially prevalent during the initial months of treatment. Strengthening ADR monitoring and early intervention can help improve treatment adherence and patient safety.

Knowledge, attitudes, and practices toward antibiotic use and resistance among medical students: a cross-sectional study

Narasimha Murthy K. M., Arun Hebbar J. N., Naveen Kumar — Fri, 22 Aug 2025 00:00:00 +0530

Background: Antimicrobial resistance (AMR) is becoming a major global health problem, which is jeopardizing the effectiveness of current antibiotics and causing increasing difficulty in routine clinical care. As future prescribers, medical students must develop strong knowledge, attitudes, and practices (KAP) to ensure effective antimicrobial stewardship (AMS). It explored the knowledge, attitude and practice of Indian undergraduate medical students concerning antibiotics and antimicrobial resistance.

Methods: A cross-sectional survey was conducted among 500 undergraduate medical students at a tertiary care hospital attached to a medical college in India. A validated, structured 30-item questionnaire based on World Health Organization (WHO) guidelines was used to assess KAP. The responses were reported using a 5-point Likert scale. Statistical analyses included t-tests, Mann-Whitney U tests, and Welch’s ANOVA to evaluate the influence of AMR training and academic progression (p<0.05).

Results: Students demonstrated strong theoretical knowledge of AMR, but reported low confidence and limited engagement in AMS activities. Only 47.6% had formal AMR training, and 16.8% participated in AMS programs. Trained students scored significantly higher in knowledge (p=0.006) but not in attitudes or practices. KAP scores improved progressively across academic years, with final-year students and interns scoring the highest.

Conclusions: While Indian medical students show a high awareness of AMR, confidence and practice-oriented engagement are limited. Curricular reforms incorporating experiential learning and early AMS integration are crucial to bridging the knowledge-practice gap.

Efficacy and safety of Amrith Noni Arthoplus in osteoarthritis: a double-blinded, randomized clinical trial

Fri, 22 Aug 2025 00:00:00 +0530

Background: Osteoarthritis (OA) is a chronic, degenerative joint disorder marked by pain, inflammation, and impaired mobility, significantly affecting quality of life. Current treatments often provide limited relief and may have adverse effects with long-term use. This study aimed to evaluate the efficacy and safety of Amrith Noni Arthoplus in individuals with OA through a double-blinded, randomized clinical trial.

Methods: This double-blind, randomized, placebo-controlled study evaluated the efficacy and safety of Amrith Noni Arthoplus, an herbal formulation containing Morinda citrifolia (Noni) as the primary ingredient, in 40 patients with osteoarthritis (OA). Efficacy was evaluated using the visual analog scale (VAS) for pain intensity, 6-minute walk test, stair climb test, physician and subject global assessments (PGA/SGA), serum biomarkers (hs-CRP, calcium, phosphorus, magnesium, vitamin D₃), and bone mineral density (BMD) via DEXA scans. Safety was assessed through vital signs, haematology, liver and kidney function tests, and adverse event monitoring.

Results: The active group demonstrated significant improvements in pain intensity (33.82% reduction in VAS scores, p<0.0001), physical function (14.17% increase in walking distance, p<0.0001), and stair climb time (12.75% reduction, p<0.0001) compared to the placebo group. Serum biomarkers, including hs-CRP (31.33% reduction, p<0.0001) and bone health markers (calcium, phosphorus, magnesium, vitamin D₃), showed significant improvements. BMD increased by 25.48% in the active group (p<0.0001), while the placebo group experienced an 18.10% decline (p=0.002). No adverse events were reported, and all safety parameters remained within normal limits.

Conclusions: Amrith Noni Arthoplus significantly alleviates OA symptoms, improves physical function, and enhances bone health, demonstrating its potential as a safe and effective complementary therapy for OA management.

Cost variation analysis of commonly used oral antidiabetic drugs available in the Indian pharmaceutical market: a cross-sectional study

Sathiyanathan T., Rie Joshi, Shailander Singh, Preeti Dharapur, Steffi Loarine — Fri, 22 Aug 2025 00:00:00 +0530

Background: Type 2 diabetes mellitus (DM) is a chronic, progressive metabolic disease that can lead to both microvascular and macrovascular problems. OHAs, or oral hypoglycemic agents, are crucial for controlling elevated blood glucose levels and treatment adherence. The cost of medications affects both patient adherence and sensible prescribing. In India, the same antidiabetic drugs are sold under several different brands at wildly disparate costs. Financial burden may result from prescribing pricey brands, particularly for long-term illnesses like diabetes mellitus. Aim was to enumerate the price of commonly used oral antidiabetic drugs in India and study the cost variation of oral antidiabetic drugs.

Methods: Data from CIMS April-June 2024 on 17 antidiabetic drugs (various strengths) were analysed. Maximum and minimum prices (per 10 tablets) were recorded. Cost differences, cost ratios, and cost variation percentages were calculated using MS Excel 2021, with data represented in tables and charts.

Results: Overall, the maximum and minimum cost variation among individual drugs were linagliptin 5 mg (586.67%) and glibenclamide 5 mg (39.80%) respectively. Among FDC’s the minimum cost variation was glibenclamide + metformin (5+500 mg SR tablet; 4.77%) and maximum cost variation was of glimepiride + metformin (1+500 mg SR tablet; 1246.47%).

Conclusions: The prices of the numerous brands of oral anti-diabetics that are sold in the Indian market vary greatly. Physicians need to be aware of these differences and prescribe medications appropriately, taking the patient’s financial situation into account and also to encourage treatment compliance.

Analyzing gaps in knowledge, attitude, and behavioral practices related to seborrhoeic dermatitis among medical undergraduate students

Rashi Singh, Savita Verma, Surabhi Dayal, Deepinder Narang — Fri, 22 Aug 2025 00:00:00 +0530

Background: Seborrhoeic dermatitis (SD) is a prevalent, chronic, inflammatory skin condition, primarily affecting areas rich in sebaceous glands, yet awareness of its etiology, management, and associated psychosocial impact remains limited. This study aimed to assess the knowledge, attitudes, and practices (KAP) regarding seborrhoeic dermatitis among undergraduate medical students.

Methods: A cross-sectional observational study was conducted from January to March 2024 at Pt. B. D. Sharma PGIMS, Rohtak, involving 379 medical undergraduates (aged 18–30). Data were collected via a structured, self-administered, expert-validated questionnaire covering general information, knowledge, attitudes, and practices regarding SD. Institutional Ethics Committee approval was obtained. Data were analyzed in Excel using descriptive statistics (mean±SD for continuous and percentages for categorical variables).

Results: Among participants, 69.9% had experienced SD, with 48.5% currently affected. Knowledge gaps were evident: only 21.4% identified SD as a chronic inflammatory condition, and 28.5% recognized Malassezia as the cause. While fungal involvement was widely acknowledged, specific understanding was limited. Only 10.9% were satisfied with current treatments, and 48.2% believed oiling was beneficial, despite contrary evidence. Practices such as towel sharing (18.6%) and frequent scalp scratching (63.8%) were common, potentially worsening the condition.

Conclusions: The study identified significant gaps in knowledge, attitudes, and practices regarding SD among medical undergraduates. Educational interventions targeting these gaps are necessary to improve awareness, debunk myths, and promote evidence-based management strategies for SD.

A comparative analysis of fluoxetine and amitriptyline in depression: assessing effectiveness and adherence in a rural hospital setting

Dhanalakshmi R., Arunkumar K., Thaslim Ridhwana Barakath Ali, Pari K., Surya R. — Fri, 22 Aug 2025 00:00:00 +0530

Background: Fluoxetine and amitriptyline are commonly prescribed antidepressants. However, the superior option in terms of effectiveness and adherence remains unclear. Medication non-adherence significantly impacts treatment outcomes. This study aims to compare the two drugs in terms of effectiveness and adherence, and to assess their correlation.

Methods: This is a single-centered, prospective observational study, conducted in the psychiatric outpatient department (OPD) of the Government Medical College and Hospital, Nagapattinam, over six months (23 July 2024 to 22 January 2025). It included 126 patients newly diagnosed with depression. Patients receiving either fluoxetine or amitriptyline were enrolled. Effectiveness was measured using the 17-item Hamilton depression rating scale (HAM-D), calculating score reduction from baseline to endpoint. The four-item Morisky scale (MMAS-4) was applied to assess the medication adherence of the participants. Data were analysed with statistical package for the social sciences (SPSS) version 24, applying descriptive analysis, independent t-test and Pearson correlation as appropriate.

Results: Depression was more prevalent among women. Most participants were married and unemployed. Fluoxetine showed a greater mean reduction in HAM-D scores compared to amitriptyline. It also demonstrated higher medication adherence. A statistically significant positive correlation between effectiveness and adherence was observed for both drugs.

Conclusions: Better clinical outcomes were associated with higher medication adherence. Fluoxetine was superior to amitriptyline in both effectiveness and adherence. These findings highlight the importance of adherence in improving depression treatment outcomes.

A study on the prevalence of risk factors associated with non-steroidal anti-inflammatory drugs-induced adverse effects among inpatients at a tertiary care hospital

Ashwini J., Benisha X. C., Hemalatha K., Sangeetha B. — Fri, 22 Aug 2025 00:00:00 +0530

Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for pain relief and as antipyretics in day-to-day life. However, their adverse effects can be intensified in the presence of certain risk factors. This study aims to identify the risk factors associated with NSAID-induced adverse effects. It also serves to support clinical pharmacists in minimizing these risks and enhancing patient safety.

Methods: Data from a total of 175 inpatients were collected prospectively using a structured data collection form based on defined inclusion and exclusion criteria. The study was conducted over a period of six months. The WHO-UMC causality assessment scale was used to evaluate adverse drug reactions (ADRs), and Hartwig’s severity assessment scale was used to determine the severity. SPSS software was employed for analysing the categorized data.

Results: Among 175 patients receiving NSAID therapy, the most prevalent risk factor identified was polypharmacy (64%), followed by older age (38%). Preventive co-therapies, such as proton pump inhibitors (PPIs), were administered in 81.1% of cases. The study also reported a specific ADR generalized pruritus induced by diclofenac, which was assessed as probable on the WHO-UMC causality scale and mild (Level 2) on Hartwig’s severity scale.

Conclusions: The study concludes that all NSAID prescriptions were rational and appropriate. Identifying risk factors and prescribing preventive co-therapies during NSAID treatment contributes to improved patient care and therapeutic outcomes.

A study on therapeutic management of allergic conjunctivitis and assessment of quality of life in patients

Fri, 22 Aug 2025 00:00:00 +0530

Background: Allergic conjunctivitis (AC) is a common ocular condition triggered by exposure to allergens. The primary objective of this study was to evaluate the therapeutic management of patients suffering from allergic conjunctivitis and to determine the prevalence of AC among patients attending an allergy center.

Methods: A retro-prospective, interventional study was conducted, for a six-month period from March to August 2024. Total of 260 patients diagnosed with AC were included from total of 1,523 individuals attending the center. Inclusion criteria focused on patients of all ages undergoing treatment for AC, excluding those with infectious conjunctivitis or other ocular pathologies. Patient data were collected using structured forms that included demographic information, presenting symptoms, other allergic conditions etc. Treatments were categorized into pharmacological, personalized and supportive therapy.

Results: Among all the 1,523 patients, 263 were diagnosed with AC, indicating a prevalence of 17.26%. Allergen testing revealed that dust mites were the leading triggers, followed by pollens. Coexisting allergic conditions were highly prevalent, particularly allergic rhinitis and dermatitis. Pharmacological therapy, like antihistamines and topical corticosteroids, was administered to 86 patients, while 105 patients received personalized treatments. A statistically significant improvement in post-treatment symptom scores was observed, with an effect size of 1.62, indicating high treatment efficacy.

Conclusions: This study highlights the need for early diagnosis, comprehensive allergen evaluation and targeted management in allergic conjunctivitis. The study contributes to the scientific understanding of AC by providing real-world data on allergen prevalence and treatment outcomes.

Adverse drug reactions to antitubercular therapy in osteoarticular tuberculosis: a retrospective observational study from a tertiary care center

Fri, 22 Aug 2025 00:00:00 +0530

Background: Osteoarticular tuberculosis (OATB) is a challenging form of extrapulmonary tuberculosis (TB) that often requires long-term multidrug regimens. Antitubercular therapy (ATT) can lead to significant adverse drug reactions (ADRs), potentially affecting patient adherence and outcomes. Objectives were to assess the types and frequencies of ATT-induced ADRs in patients treated for osteoarticular TB.

Methods: This retrospective observational study included 27 patients diagnosed with OATB, who were treated at Dr. RPGMC Tanda. Patient records and telephone interviews were used to collect data on ADRs. Descriptive statistics were used for analyses.

Results: Of 27 patients, 13 (48.1 %) experienced ADRs. GI symptoms were the most common (18.5%), followed by dermatological (11.1%) and neurological (11.1%) side effects. One case each of hepatotoxicity with liver failure and epistaxis, and two cases of ocular symptoms were recorded.

Conclusions: Nearly half of the patients developed ADRs to ATT. Regular monitoring and early intervention are essential to improve treatment compliance and patient safety.

A study on drug utilization, evaluation and monitoring of adverse drug reactions in the cardiology department of a tertiary care hospital

Fri, 22 Aug 2025 00:00:00 +0530

Background: Cardiovascular diseases require complex pharmacotherapy, increasing the risk of Adverse Drug Reactions (ADRs). Monitoring drug utilization and ADRs is essential to enhance patient safety.

Methods: A prospective observational study was conducted over 3 months (April 2025-June 2025) in the Cardiology Department of a tertiary care hospital. Fifty inpatients aged ≥18 years were monitored for ADRs. Causality was assessed using the Naranjo Scale and WHO-UMC criteria; severity was evaluated using the Hartwig Scale.

Results: A total of 50 ADRs were reported, with hematological (36%), gastrointestinal (24%), and cardiovascular (16%) systems most affected. Anticoagulants, antiplatelets, diuretics, RAAS inhibitors, and SGLT2 inhibitors were commonly implicated. Most ADRs were moderate (50%), with 62% categorized as probable. No fatalities occurred; 66% of patients recovered fully.

Conclusions: ADRs are common among cardiology inpatients, with polypharmacy and comorbidities as key risk factors. Regular pharmacovigilance, patient monitoring, and individualized therapy are essential to minimize ADR-related complications.

A prospective, randomized, open-label study to compare the different dosage forms of omega 3 fatty acids as an adjuvant in the bipolar depression

Rahuli, Neeru Bala, Gurpreet Kaur Randhawa — Fri, 22 Aug 2025 00:00:00 +0530

Background: 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.

Drug utilization study of drugs prescribed in patients suffering from chronic obstructive pulmonary disease attending the pulmonary medicine outpatient department of a tertiary care hospital-an observational study

Fri, 22 Aug 2025 00:00:00 +0530

Background: Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disorder requiring long-term pharmacological management. This study aimed to evaluate prescription patterns, drug utilization, polypharmacy and cost analysis in COPD patients attending the outpatient department of a tertiary care hospital.

Methods: This single-center, cross-sectional observational study was conducted in collaboration with the Department of Pulmonary Medicine. A total of 600 prescriptions of COPD patients were analyzed over 18 months (January 2020–June 2021) following WHO guidelines for Drug Utilization Studies. Adult patients diagnosed with COPD and attending the outpatient department were included. Data on demographics, drug classes, fixed-dose combinations (FDCs), essential drug listing and cost burden were collected and analyzed using descriptive statistics.

Results: The average age of patients was 62.87±14.52 years, with 84.67% being male. A total of 3815 drugs were prescribed, with bronchodilators (62.70%) being the most common class, followed by corticosteroids (8.10%). Tiotropium bromide and Salbutamol were the most frequently used individual drugs. The average number of drugs per prescription was 6.36±2.31, indicating polypharmacy. Fixed-dose combinations such as Theophylline+Etophylline (41.87%) were commonly prescribed. The average prescription cost was 647.23 INR, of which 44.90% was borne by patients. Most drugs (69.78%) were prescribed by generic names and 62.43% were from the National Essential Medicines List.

Conclusions: This study highlights a significant degree of polypharmacy and suggests that while prescribing trends largely align with GOLD guidelines, greater access to essential drugs through hospital pharmacies and efforts to reduce patient cost burden are warranted.

Study of adverse drug reaction of intravesical onco-BCG in non-muscle-invasive bladder cancer: a retrospective study

Ira Sharma, Kulbhushan Sharma, Atal Sood — Fri, 22 Aug 2025 00:00:00 +0530

Background: Intravesical onco-BCG is mainstay therapy for intermediate and high‑risk NMIBC to reduce disease recurrence and progression. In India Danish 1331 strain was used till middle of last decade after that Moscow (Russia) strain is used.

Methods: Retrospective study was conducted in intermediate and high risk NMIBC patients. Patients receiving were interviewed for ADR’s and were recorded as grade 1, grade 2, grade 3 symptoms (as per Cleveland clinic approach to management of BCG toxicity). The patients with NMIBC (Ta or T1 diseases as per TNM staging AJCC 8^th edition) in intermediate and high-risk group were enrolled in the study. The diseases classified in low risk, intermediate risk and high risk as per EAU guidelines.

Results: Sixty patients were enrolled in the study. Mean age of the patients is 62.75 years with male: female ratio 20:1. 46.6% of patients had intermediate and 53.4% had high risk disease. Mean follow-up period in the study was 32.27 weeks. 93.4% of patients had grade 1 symptoms and 6.6% had grade 2 symptoms. None of the patients had grade 3 serious complications.

Conclusions: Intravesical OncoBCG (Moscow strain) is safe and well tolerated in study population.

A cross-sectional observational study of postoperative restricted antibiotic utilization, rationality, and cost analysis in a tertiary care teaching hospital

Shreya Gade, Aditya Dhumale, Uma A. Bhosale — Fri, 22 Aug 2025 00:00:00 +0530

Background: Antimicrobial resistance (AMR) is an alarming condition that has been arising due to many interconnected factors, in particular, the use and misuse of antimicrobials. It is more prevalent in developing countries like India where there is a huge burden of infectious diseases. There has been insufficient research data to conclusively comment on the judicious use of antimicrobials. Therefore, this study is designed to assess the judicious use of antimicrobials on the basis of modified Kunin’s criteria and analyse the cost and its rationality.

Methods: Cross sectional observational study wherein patient data for last 2 year postoperative patients was analyzed.

Results: In the present study, a significant number of patients (82.76%) the restricted antimicrobials were used judiciously and majority of then (42.19%) incurred a cost of <10000 INR.

Conclusions: The study shows that with appropriate and strict measures it is possible to limit the use of restricted antimicrobials. This further helps to decrease emerging antimicrobial resistance and also decrease the cost incurred by the patients during their hospital stay.