International Journal of Basic & Clinical Pharmacology
Not a member yet
3901 research outputs found
Sort by
In vivo antibacterial activity and biochemical effects of methanol extract of Annona muricata leaves against multidrug- resistant Salmonella Typhimurium in Wistar rats
Full text linkBackground: The increasing antibiotic resistance and paucity of new antibiotics has contributed greatly to the high morbidity and mortality of salmonellosis necessitating the search for alternative treatments. Annona muricata has shown promising activity against multidrug-resistant (MDR) Salmonella in vitro but in vivo studies are rare. This study evaluated the activity of A. muricata, against MDR Salmonella Typhimurium in vivo.
Methods: The minimum inhibitory concentration (MIC) of a methanol crude extract of A. muricata was determined by micro-dilution assay against a characterized MDR clinical S. Typhimurium strain. Wistar rats infected with 3 x 108 CFUs/mL of the MDR strain were treated with 50-200 mg/kg body weight of extract for 10 days. Faecal load of S. Typhimurium colonies was determined by the direct plate count technique on days 1, 5 and 10. Animals were sacrificed and blood was collected for biochemical analyses. Data were analysed using GraphPad Prism Software.
Results: The S. Typhimurium strain was multidrug-resistant and the extract recorded a MIC of 2 mg/ml The extract produced a significant (p<0.001) dose-dependent reduction in Salmonella colonies in faeces of treated rats with a 100% inhibition recorded at 200 mg/kg body weight on day 10. Liver and renal function tests did not indicate any abnormalities (p<0.05).
Conclusions: This is the first report of in vivo activity of A. muricata leaves against multidrug-resistant Salmonella. The high activity and lack of adverse toxicity supports it use in traditional medicine and hence is a potential treatment for resistant Salmonella infections.
Individual component analysis of gastrointestinal symptom rating scale for irritable bowel syndrome in irritable bowel syndrome patients treated with Bacillus coagulans SNZ 1969: additional findings from a randomized, double-blind, placebo-controlled study
Full text linkThis study evaluated the therapeutic efficacy of Bacillus coagulans SNZ 1969 (B. coagulans SNZ 1969) in patients with constipation-predominant irritable bowel syndrome (IBS-C) and diarrhea-predominant IBS (IBS-D). We conducted a randomized, double-blind, placebo-controlled trial in 80 patients (40 IBS-C, 40 IBS-D) who received either B. coagulans SNZ 1969 (500 million CFU) or placebo twice daily for 60 days. Assessments were performed at baseline and on days 30, 60, and 75. Here we present the additional findings of the individual components of Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS). Results demonstrated significant reductions in all individual components of GSRS-IBS (abdominal pain, bloating, constipation, diarrhea, and satiety) in both IBS-C and IBS-D patients treated with B. coagulans SNZ 1969 compared to placebo. In conclusion, B. coagulans SNZ 1969 found to be an effective therapeutic option for IBS, demonstrating broad efficacy across multiple symptom domains
A comprehensive review on acarbose in glycaemia control: current insights and future prospects
Full text linkThis comprehensive review examines the part of acarbose in glycaemic control, particularly in managing Glycaemic control among type 1, and also type 2 diabetes mellitus (T2DM) along with gestational diabetes mellitus (GDM). Acarbose, an alpha-glucosidase inhibitor, works by delaying carbohydrate (carb.) digestion in the small intestine (SI), thereby preventing sharp postprandial blood glucose (BG) spikes. This mechanism of action is crucial for maintaining stable glycaemic levels (lvl.s) and reducing HbA1c, which is vital in preventing long-term diabetes complications. The review highlights recent clinical studies that demonstrate acarbose’s efficacy and safety profile, including its minimal systemic absorption and tolerability across diverse patient populations. Additionally, it explores the potential of acarbose in combination therapy with other antidiabetic agents (ADAs), emphasizing its complementary effects in enhancing overall glycaemic control. Furthermore, the discussion addresses emerging trends, ongoing research, and future directions for acarbose in diabetes management, underscoring its significance as a valuable tool in therapeutic strategies aimed at improving patient outcomes
Adverse drug reaction reporting in a tertiary care teaching hospital of Eastern Odisha: a five-year retrospective study
Full text linkBackground: Adverse drug reactions (ADRs) related morbidity and mortality is a concern as it reduces quality of life, prolongs hospital stay and inflicts significant burden on the healthcare resources. This study was under taken to evaluate the patterns of spontaneously reported ADRs, at an ADR monitoring centre (AMC) in a tertiary care teaching hospital in Eastern India.
Methods: The present study was carried out for a period of five years from January 2020 to December 2024. Data were analysed for their demographic patterns, associated medications and reactions, system organ class affected, seriousness, outcomes and causality using the WHO causality scale. Mean, standard deviation, Chi-square ‘p’ and binomial ‘p’ were analysed.
Results: Total ADRs reported was 500. Highest ADRs was in the group of 30-60 years (48.6%), females reporting was 52.4%. Maximum cases reported in 2024 (42%). Department of psychiatry reported maximum ADRs (17.8%). 51.8% cases reported possible causality. Rash was the most common ADR in 25.6% and ceftriaxone sulbactam combination caused 16% ADRs. The most affected system organ class was skin and subcutaneous tissue disorder (61%).
Conclusions: The study depicted the pattern of reactions to various medications and helpful in augmenting the awareness of spontaneous reporting of ADRs amongst healthcare professionals, thereby enhancing patient safety and improving the quality of life
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
Full text linkBackground: 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.
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
Full text linkBackground: 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
A randomized controlled trial comparing sacubitril/valsartan and telmisartan in patients with HFrEF: efficacy and safety evaluation
Full text linkBackground: Heart failure with reduced ejection fraction (HFrEF) is a progressive condition associated with high morbidity, mortality, and healthcare costs. Sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor (ARNI), has demonstrated superior efficacy over traditional angiotensin receptor blockers (ARBs) in improving outcomes. This study compared the safety and efficacy of sacubitril/valsartan with telmisartan monotherapy in HFrEF patients.
Methods: A randomized, prospective, open-label, interventional study was conducted at a tertiary care center over six months. A total of 81 patients with HFrEF (EF ≤40%) were randomized into group A (telmisartan 40 mg daily) and group B (sacubitril/valsartan 200 mg twice daily). Outcomes assessed included NYHA class, left ventricular ejection fraction (LVEF), and serum BNP levels at baseline, 3 months, and 6 months. Safety was evaluated through adverse events and laboratory monitoring. Statistical analysis was conducted using SPSS, with significance set at p<0.05.
Results: Both groups showed significant improvement in LVEF and BNP levels. Sacubitril/valsartan demonstrated superior efficacy in reducing BNP levels (583.2±324.2 pg/ml versus 957.5±305.2 pg/ml, p<0.0001) and improving NYHA class (p=0.005). LVEF improved significantly in both groups, with no intergroup difference (p=0.130). No hospitalizations or mortality occurred during the study. One case of non-serious angioedema was reported in the sacubitril/valsartan group. Hematological and biochemical parameters remained stable, confirming comparable safety profiles.
Conclusions: Sacubitril/valsartan is more effective than telmisartan in improving NYHA class and reducing BNP levels in HFrEF patients, with a comparable safety profile. It should be considered a preferred treatment option in HFrEF management, particularly in patients with NYHA class II/III symptoms, as per ACC/AHA guidelines
Factors influencing the clinical ineffectiveness of antibiotics in non-responders
Full text linkBackground: Antibiotic ineffectiveness and clinical non-responsiveness remain significant challenges in healthcare. Non-responders-patients who fail to improve despite appropriate antibiotic therapy-pose a substantial clinical burden. Identifying factors influencing such outcomes is essential for improving treatment success. To investigate patient, hospital-related factors contributing to antibiotic ineffectiveness despite culture sensitivity.
Method: A six-month ambispective observational study was conducted at PSG Hospitals, Coimbatore, India. A total of 480 inpatients were included into the study. Highly prescribed antibiotics-Cefoperazone+Sulbactam, Meropenem, Piperacillin Tazobactam, and Ceftriaxone-were analyzed. Factors such as age, gender, type of bacteria, prior antibiotic exposure, prior hospitalization, invasive procedures, and length of hospital stay were examined. Statistical analysis was performed using SPSS, with p values < 0.05 considered significant.
Results: Among 480 patients equally divided across four antibiotic groups, age was significant in the Meropenem group (p=0.044) in contrast to the rest of the groups. Prior antibiotic exposure (OR range: 1.091–1.889; p<0.05) and longer hospital stay (OR range: 1.271–1.710; p<0.001) were significantly associated with non-response across all the four antibiotic groups. Klebsiella pneumoniae was significantly linked to non-response across all groups (OR range: 1.025–1.801; all p<0.01). Invasive procedures were significant for Cefoperazone–Sulbactam (OR=2.148, p=0.030) and Piperacillin–Tazobactam (OR=1.643, p=0.012).
Conclusion: Prior antibiotic exposure, prolonged hospital stays, and the presence of Klebsiella pneumoniae were significantly associated with antibiotic non-responsiveness. This suggests a multifaceted approach addressing patient, microbial, and institutional factors might lessen disruptions to optimal clinical effectiveness.
Assessment of knowledge, attitude and practices of pharmacovigilance among health care professionals at a tertiary care teaching hospital in Central India
Full text linkBackground: Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality worldwide and remain substantially underreported. Pharmacovigilance and spontaneous ADR reporting by health care professionals (HCPs) are critical to identify and mitigate drug-related harm. Our study assessed knowledge, attitude and practice (KAP) regarding pharmacovigilance and explored factors underlying ADR underreporting among HCPs at a tertiary teaching hospital in central India.
Methods: A cross-sectional questionnaire-based survey was administered via Google forms to 160 consenting HCPs (48 doctors, 112 nurses) at a tertiary care teaching hospital. The instrument contained 15 KAP items (5 knowledge-yes/no; 5 attitude-5-point Likert; 5 practice-yes/no) plus a multiple-option item on causes of underreporting. Pretesting, expert validation and Cronbach’s α (0.773) were done. Descriptive statistics were computed.
Results: All doctors (100%) correctly identified ADRs and life-threatening potential; 93.8% recognized that rare ADRs are primarily identified in post-marketing (phase IV) surveillance. Nurses demonstrated high recognition of ADR concept (88.4%) but lower awareness on some specifics (e.g., 67.9% aware that rare ADRs appear in phase IV). Practice differed markedly: while 91.7% of doctors reported routinely encountering ADRs and 89.6% acknowledged ADR documentation, only 16.7% of doctors reported using the covigilance programme of India (PvPI) mobile app; nurses reported substantially lower active reporting behaviours (practice item responses range 6.3-48.2%). Major reasons for underreporting cited were lack of knowledge (doctors 85.4%, nurses 75.0%), difficulty in causality decision (doctors 56.3%, nurses 48.2%), and limited access to reporting forms (doctors 47.9%, nurses 36.6%).
Conclusions: HCPs exhibited satisfactory knowledge and positive attitudes but suboptimal reporting practices, especially among nurses. Interventions such as targeted training, simplified reporting pathways, and institutional pharmacovigilance centres are recommended to improve ADR reporting rates
Comparison of safety and efficacy of desidustat with erythropoietin in newly diagnosed patient of anemia in chronic kidney disease: a prospective, open label, randomized controlled trial
Full text linkBackground: Anemia is a frequent complication of chronic kidney disease (CKD), affecting quality of life and increasing cardiovascular risks. Erythropoiesis-stimulating agents (ESAs) like erythropoietin are standard treatments but raise concerns about safety and long-term outcomes. Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), such as desidustat, have emerged as potential alternatives. This study compared the safety and efficacy of desidustat with erythropoietin in adults with CKD-associated anemia.
Methods: A randomized controlled trial was conducted in the Departments of Nephrology and Pharmacology at Dr. R.P.G.M.C. Kangra at Tanda. Adult CKD patients (>18 years) with anemia, whether on dialysis or not, were enrolled. Participants received either oral desidustat (50 mg thrice weekly) or subcutaneous erythropoietin alfa (50 IU/kg two to three times weekly). Doses were adjusted to maintain haemoglobin (Hb) between 10-11 g/dl. Hematological and biochemical parameters were assessed at baseline, one month and three months.
Results: A total of 109 patients were randomized: 54 to desidustat and 55 to erythropoietin. Baseline characteristics, including age, weight and BMI, were comparable. Both groups showed a significant increase in haemoglobin from baseline to follow-ups (p<0.001). At three months, mean Hb rose by 1.65 g/dl in the desidustat group and by 1.31 g/dl in the erythropoietin group.
Conclusions: Desidustat demonstrated efficacy and safety comparable to erythropoietin in managing CKD-associated anemia. Its oral administration offers practical advantages, supporting its role as a promising alternative pending further large-scale studies