International Journal of

Pharmaceutical Quality Assurance

e-ISSN: 0975 9506

p-ISSN: 2961-6093

Peer Review Journal

Impact Score 3.213

Disclimer: Embase, Scopus and Crossref are registered trademark of respective companies.

This journal is member of Crossref. 

1. Clinical Profile and Outcome of Acute Respiratory Distress Syndrome in Adult ICU Patients
Chetan D. Bengalur, Shanthala S. Naik
Abstract
Background: Acute Respiratory Distress Syndrome (ARDS) is a life-threatening cause of acute hypoxemic respiratory failure associated with high mortality in intensive care units. Early identification of prognostic factors may improve patient management and outcomes. Objectives: To evaluate the clinical profile, etiological factors, severity, and outcomes of adult patients with ARDS admitted to the intensive care unit. Methods: This prospective observational study included 180 adult patients diagnosed with ARDS according to the Berlin Definition. Demographic characteristics, etiology, severity of ARDS, laboratory findings, ventilatory parameters, APACHE II score, SOFA score, complications, and clinical outcomes were recorded. Patients were followed until ICU discharge or death. Results: Of the 180 patients, 68 (37.8%) died during ICU stay. Pneumonia (41.1%) was the most common cause of ARDS, followed by sepsis (28.9%). Severe ARDS was significantly associated with increased mortality (p<0.001). Non-survivors had significantly higher APACHE II and SOFA scores, lower PaO₂/FiO₂ ratios, longer duration of mechanical ventilation, and higher incidences of acute kidney injury and multiorgan dysfunction syndrome (p<0.001). Multivariate analysis identified severe ARDS, SOFA score ≥10, APACHE II score ≥20, acute kidney injury, multiorgan dysfunction syndrome, and age >60 years as independent predictors of mortality. Conclusion: ARDS remains associated with considerable ICU mortality. Disease severity, organ dysfunction, and higher illness severity scores are major predictors of adverse outcomes. Early recognition, lung-protective ventilation, and comprehensive management of associated organ dysfunction are essential to improve survival in adult patients with ARDS.

2. Correlation of Lactate/Albumin Ratio with Severity and Mortality in Critically Ill Patients
Shanthala S. Naik, Rashmi Ashok Baligatti
Abstract
Background: Early prediction of disease severity and mortality is essential in the management of critically ill patients. The lactate/albumin ratio (LAR) has emerged as a novel prognostic biomarker that combines indicators of tissue hypoperfusion and nutritional-inflammatory status. Objective: To evaluate the correlation between the lactate/albumin ratio, illness severity, and mortality in critically ill patients admitted to the intensive care unit. Methods: This prospective observational study included 150 critically ill adult patients admitted to the ICU of a tertiary care hospital. Serum lactate and albumin levels were measured within 24 hours of admission, and the lactate/albumin ratio was calculated. Disease severity was assessed using APACHE II and SOFA scores. The primary outcomes were correlation of LAR with illness severity and hospital mortality, while secondary outcomes included mechanical ventilation, vasopressor requirement, and ICU length of stay. Results: The mean age of the study population was 56.8 ± 16.4 years, and overall hospital mortality was 31.3%. Non-survivors had significantly higher lactate/albumin ratios than survivors (2.18 ± 0.71 vs. 0.82 ± 0.34; p < 0.001). The lactate/albumin ratio showed strong positive correlations with APACHE II (r = 0.71) and SOFA (r = 0.76) scores. Elevated LAR was significantly associated with increased need for mechanical ventilation, vasopressor support, prolonged ICU stay, and nearly six-fold higher odds of hospital mortality. Receiver operating characteristic analysis demonstrated excellent predictive performance for mortality with an AUC of 0.89. Conclusion: The lactate/albumin ratio is a reliable and cost-effective prognostic biomarker that correlates closely with disease severity and mortality in critically ill patients. Its routine use at ICU admission may improve early risk stratification and support timely clinical decision-making.

3. Correlation of Serum Albumin with Severity and Outcome in Community-Acquired Pneumonia
Chetan D. Bengalur, Shanthala S. Naik
Abstract
Background: Community-acquired pneumonia (CAP) remains an important cause of hospitalization and mortality worldwide. Early identification of patients at risk for severe disease is essential for improving clinical outcomes. Serum albumin has emerged as a potential biomarker reflecting both nutritional status and systemic inflammation. Objectives: To evaluate the correlation between serum albumin levels, disease severity, and clinical outcomes in patients with community-acquired pneumonia. Methods: This prospective observational study included 160 adult patients admitted with community-acquired pneumonia. Serum albumin levels were measured within 24 hours of admission. Disease severity was assessed using CURB-65 and Pneumonia Severity Index (PSI) scores. Patients were followed until discharge or death. Clinical outcomes including ICU admission, mechanical ventilation, duration of hospitalization, and in-hospital mortality were analyzed. Results: The mean serum albumin level was significantly lower among non-survivors than survivors (2.71 ± 0.39 vs. 3.48 ± 0.42 g/dL; p<0.001). Serum albumin showed a significant negative correlation with CURB-65 (r = −0.64) and PSI scores (r = −0.69) (p<0.001). Patients with hypoalbuminemia experienced significantly higher rates of ICU admission, mechanical ventilation, sepsis, prolonged hospital stay, and mortality. Multivariate logistic regression identified serum albumin <3.0 g/dL as an independent predictor of in-hospital mortality (OR 4.32; 95% CI 1.89–9.91; p<0.001). Conclusion: Hypoalbuminemia is strongly associated with increased disease severity and adverse clinical outcomes in community-acquired pneumonia. Serum albumin is an easily available and cost-effective prognostic marker that complements established severity scoring systems and may assist in early risk stratification and management.

4. Clinical Profile and Outcome of Acute Meningitis Patients Admitted to the Intensive Care Unit
Chetan D. Bengalur, Shanthala S. Naik
Abstract
Background: Acute meningitis is a life-threatening neurological emergency associated with high morbidity and mortality, particularly among patients requiring intensive care unit (ICU) admission. Early diagnosis and prompt management are essential to improve survival and reduce neurological complications. Objectives: To evaluate the clinical profile, etiological pattern, management, and outcomes of patients with acute meningitis admitted to the intensive care unit and to identify factors associated with mortality. Materials and Methods: This prospective observational study included 120 consecutive patients with acute meningitis admitted to the ICU of a tertiary care hospital over an 18-month period. Demographic characteristics, clinical presentation, laboratory and cerebrospinal fluid findings, neuroimaging, treatment modalities, complications, and clinical outcomes were recorded. Patients were categorized into survivors and non-survivors for comparative analysis. Statistical analysis was performed using SPSS version 26.0, and a p-value <0.05 was considered statistically significant. Results: The mean age of the patients was 42.8 ± 16.4 years, with males comprising 66.7% of the study population. Acute bacterial meningitis was the commonest etiology (60.0%), followed by tuberculous (23.3%), viral (13.3%), and fungal meningitis (3.4%). Fever (93.3%), headache (86.7%), neck stiffness (75.0%), and altered sensorium (68.3%) were the predominant presenting features. Mechanical ventilation was required in 28.3% of patients, while raised intracranial pressure (23.3%) and septic shock (16.7%) were the most common complications. The overall in-hospital mortality was 24.2%. Older age, Glasgow Coma Scale score ≤8, septic shock, raised intracranial pressure, requirement for mechanical ventilation, and prolonged ICU stay were significantly associated with mortality (p<0.05). Conclusion: Acute bacterial meningitis remains the predominant cause of ICU admission among patients with acute meningitis and is associated with considerable mortality. Poor neurological status at admission and severe systemic complications significantly influence clinical outcomes. Early recognition, prompt antimicrobial therapy, and comprehensive intensive care management are crucial for improving survival and reducing neurological sequelae.

5. Comparative Study of Preoperative Anxiety and Perioperative Outcomes Between General and Regional Anaesthesia Patients at a Tertiary Care Institute
Priyanka Deshmukh, Sohal Parate, Shweta Takalkar, Karuna Gaikwad
Abstract
Background:  It is well documented that surgical patients struggle with anxiety prior to surgery, and may be influenced by pain perception after surgery, patient recovery and their experience of surgery. Type of anaesthesia could effect on anxiety and peri-operative outcomes. The present study analyzed the differences between the peri-operative situation of two groups of patients – under general anaesthesia (GA) and under regional anaesthesia (RA) – in terms of their level of preoperative anxiety. Objectives: To see how much anxiety there is in GA patients compared to RA patients, difference in pain after anaesthesia, need of analgesics, PONV, recovery time, hospital stay, recovery satisfaction and anaesthetic complications. Materials and Methods: Comparative study of 120 surgical cases have been performed between the two January 2024 and December 2024 in Datta Meghe Medical College, Wanadongri, Nagpur. In all 60 patients were given GA and 60 were given RA. A pre-standardized anxiety questionnaire was used to evaluate pre-operative anxiety. Data pertaining to perioperative outcomes were recorded and compared between the two groups. A P value <0.05 was considered statistically significant. Results: The admissions anxiety score was significantly higher in GA group compared to RA group. Patients had moderate-severe anxiety in 36.7% and 20.0%, respectively (P = 0.048). Postoperative pain at 6 hours was higher with GA (4.1 ± 1.3 vs. 2.8 ± 1.1; P < 0.001), with greater rescue analgesic use (61.7% vs. 35.0%; P = 0.004). The rates of postoperative nausea and vomiting (PONV) were 25.0% versus 10.0% (P = 0.032). Recovery time was longer with GA (42.6 ± 10.8 vs. 31.4 ± 8.7 minutes; P < 0.001). Hospital stay was comparable (3.8 ± 1.2 vs. 3.4 ± 1.0 days; P = 0.061), while satisfaction was higher with RA (88.3% vs. 73.3%; P = 0.034). Conclusions: Regional anesthesia was associated with lower levels of anxiety prior to surgery, less postoperative pain or need for pain medications, fewer episodes of PNV, quicker recovery and more patient satisfaction than general anesthesia. In conclusion, the present results are suggestive of anesthetic technique as a relevant factor to be taken into account towards optimizing peri-operative outcomes.

6. Clinical Profile and Outcome of Acute Meningitis Patients Admitted to the Intensive Care Unit
Chetan D. Bengalur, Shanthala S. Naik
Abstract
Background: Acute meningitis is a life-threatening neurological emergency associated with high morbidity and mortality, particularly among patients requiring intensive care unit (ICU) admission. Early diagnosis and prompt management are essential to improve survival and reduce neurological complications. Objectives: To evaluate the clinical profile, etiological pattern, management, and outcomes of patients with acute meningitis admitted to the intensive care unit and to identify factors associated with mortality. Materials and Methods: This prospective observational study included 120 consecutive patients with acute meningitis admitted to the ICU of a tertiary care hospital over an 18-month period. Demographic characteristics, clinical presentation, laboratory and cerebrospinal fluid findings, neuroimaging, treatment modalities, complications, and clinical outcomes were recorded. Patients were categorized into survivors and non-survivors for comparative analysis. Statistical analysis was performed using SPSS version 26.0, and a p-value <0.05 was considered statistically significant. Results: The mean age of the patients was 42.8 ± 16.4 years, with males comprising 66.7% of the study population. Acute bacterial meningitis was the commonest etiology (60.0%), followed by tuberculous (23.3%), viral (13.3%), and fungal meningitis (3.4%). Fever (93.3%), headache (86.7%), neck stiffness (75.0%), and altered sensorium (68.3%) were the predominant presenting features. Mechanical ventilation was required in 28.3% of patients, while raised intracranial pressure (23.3%) and septic shock (16.7%) were the most common complications. The overall in-hospital mortality was 24.2%. Older age, Glasgow Coma Scale score ≤8, septic shock, raised intracranial pressure, requirement for mechanical ventilation, and prolonged ICU stay were significantly associated with mortality (p<0.05). Conclusion: Acute bacterial meningitis remains the predominant cause of ICU admission among patients with acute meningitis and is associated with considerable mortality. Poor neurological status at admission and severe systemic complications significantly influence clinical outcomes. Early recognition, prompt antimicrobial therapy, and comprehensive intensive care management are crucial for improving survival and reducing neurological sequelae.

7. Impact of AETCOM Modules about Communication, Bioethics and Professionalism in Second Year MBBS Students
Kavya B. S., Susheela Halemani, Eshanu H. Shastry, Allen Joe Rodrigues
Abstract
Background: The Attitude, Ethics, and Communication (AETCOM) module was introduced under the Competency-Based Medical Education (CBME) curriculum to strengthen communication skills, ethical reasoning, and professionalism among undergraduate medical students. Evidence regarding its impact among second-year MBBS students remains limited. Objectives: To evaluate the effectiveness of AETCOM modules in enhancing communication skills, ethical awareness, and professional behaviour among second-year MBBS students. Material And Methods: A prospective, single-arm, quasi-experimental pre- and post-test study was conducted among 171 second-year MBBS students at Subbaiah Institute of Medical Sciences, Shivamogga. The intervention consisted of the mandatory 16-hour AETCOM module delivered through interactive lectures, case discussions, role-plays, and reflective learning sessions. A validated 25-item questionnaire assessed knowledge across communication, bioethics, and professionalism domains (20 items) and perceptions toward AETCOM (5 Likert-scale items). Pre- and post-intervention scores were compared using paired statistical tests. Results: The overall knowledge score increased from 15.84 ± 3.10 in the pre-test to 16.26 ± 2.94 in the post-test (t = 1.91, p = 0.058). Domain-specific scores showed modest improvement in doctor-patient communication and rapport (8.92 ± 1.18 to 9.08 ± 1.12), bioethics principles and consent application (5.33 ± 2.05 to 5.52 ± 1.98), and professional conduct and confidentiality (1.58 ± 0.62 to 1.66 ± 0.56), with no statistically significant differences (p > 0.05). Perceptions toward AETCOM were favorable, with increased agreement across all assessed constructs after the intervention. Conclusion: Second-year MBBS students demonstrated high baseline knowledge and positive perceptions toward AETCOM. The module produced modest improvements in knowledge and perceptions, although the short-term changes were not statistically significant.

8. Clinical Outcomes of Intrauterine Balloon Tamponade for Postpartum Hemorrhage in Placenta Previa and Placenta Accreta Spectrum
Devi S. Bhanvadia
Abstract
Introduction: Postpartum hemorrhage associated with placenta previa and placenta accreta spectrum (PAS) is a major obstetric emergency. Intrauterine balloon tamponade (IUBT) provides a conservative mechanical approach to control bleeding and potentially avoid definitive surgery. Materials and Methods: A prospective observational cohort study was conducted over one year at a tertiary-care teaching hospital in Western Gujarat, India. A total of 76 women with placenta previa and/or PAS complicated by PPH and managed with IUBT were evaluated for obstetric characteristics, balloon use, hemorrhage control, transfusion requirements, and maternal and neonatal outcomes. Results: Previous cesarean or uterine surgery was present in 68.4% of women, while placenta previa and PAS constituted the major placental abnormalities. The Bakri balloon was used in 92.1% of cases, most commonly with an inflation volume of 200–300 mL and maintained for 12–24 hours. Obstetric hysterectomy was required in 7.9% of cases, with no maternal mortality; satisfactory maternal recovery was observed in all patients. 90.8% of neonates were alive at birth. Conclusion: IUBT appears to be a useful conservative option for managing PPH associated with placenta previa and PAS. It may facilitate hemorrhage control and avoid definitive surgery in appropriately selected patients, although invasive PAS may require additional surgical management.

9. A Study on Methotrexate Dosing Regimen for Plaque Type Psoriasis Patients
Swetha Sridhar, Chinmai C. Chikkalagi, Ashwini D.
Abstract
Introduction: Methotrexate (MTX, a dihydrofolate reductase inhibitor), is a sys- temic treatment for psoriasis. (1–3) The effectiveness and safety of this drug are acknowledged in guidelines and studies from around the world. Materials and Methods: This study was conducted in the department of Dermatology. Seventy three patients between 18 to 50 years of age suffering from plaque type psoriasis with PASI score of >10 were included in the study after taking the informed consent. Oral methotrexate in a dose of 7.5 mg/week was given for 8 weeks. Results: Out of 73 patients there were 45 (61.6%) males and 28 (38.4%) females. The mean ±SD age was 40.0±12.6 years. The mean baseline PASI score showed clear and comparable improvement from a mean ± SD PASI score of 14.8±4.2 to 4.9±4.3. Twenty nine (40%) patients had an almost complete remission during the 8 weeks of treatment. Conclusion: Treatment with methotrexate for chronic plaque psoriasis brings satisfactory disease control and improved quality of life.

10. Usefulness of pROX Index Score to Assess the Outcome of Patients with Lower Respiratory Tract Infection (Pneumonia and Bronchiolitis) on High Flow Nasal Cannula
Vinay Kumar B., G. V. Basavaraja, Sathvika Chandrashekara Reddy, Priyanka A.R., Jacqueline A. Shah
Abstract
Background: High-flow nasal cannula is increasingly used in children with lower respiratory tract infections, although early identification of patients at risk of treatment failure remains challenging. Aim: To assess the usefulness of the pediatric ROX index in predicting outcomes among children with pneumonia and bronchiolitis receiving HFNC therapy. Methods: This prospective observational study included 80 children aged 1 month to 5 years requiring HFNC for lower respiratory tract infection. Heart rate, respiratory rate, SpO₂, FiO₂, clinical respiratory signs, and pROX values were assessed serially. ROC analysis was performed to determine the predictive accuracy of pROX. CRP and procalcitonin were also evaluated. Results: Mean SpO₂ increased from 92.4 ± 4.1% at 30 minutes to 98.9 ± 1.2% at 24 hours, while respiratory rate decreased from 62.8 ± 12.4 to 40.1 ± 7.9 breaths/min. Mean pROX increased from 1.98 ± 0.71 to 3.15 ± 0.88. The 6-hour pROX demonstrated an AUC of 0.876. At a cutoff of 2.2, sensitivity was 83.3%, specificity 88.9%, PPV 80%, and NPV 91.4%. A pROX <2 at 6 hours was significantly associated with clinical deterioration or escalation of respiratory support (OR 5.4; p<0.001). Combined CRP >100 mg/L and PCT >2 ng/mL showed 100% specificity for bacterial pneumonia. Conclusion: Serial pROX measurement, particularly at 6 hours, may serve as a useful non-invasive predictor of HFNC outcome in children with pneumonia and bronchiolitis.

11. Evaluation of Second Trimester Serum Beta-Human Chorionic Gonadotropin (β-hCG) Levels as a Predictive Marker for Pregnancy-Induced Hypertension
Pramod R. Kulkarni, Mahesh Reddy, Preetam
Abstract
Background & Objectives: Hypertensive disorders of pregnancy, particularly pregnancy-induced hypertension (PIH) and preeclampsia, remain leading causes of maternal and perinatal morbidity and mortality worldwide. Abnormal placentation occurring between 8 to 18 weeks of gestation triggers hypoxic trophoblastic stress and hypersecretion of human chorionic gonadotropin (hCG). This study aimed to evaluate the clinical efficacy and predictive accuracy of second-trimester serum beta-human chorionic gonadotropin (β-hCG) levels (at 16–20 weeks of gestation) for the subsequent development and severity of PIH. Methods: A prospective observational study was conducted involving 100 pregnant women with singleton pregnancies between 16–20 weeks of gestation attending the antenatal clinic. Baseline clinical evaluations and serum β-hCG estimations via Chemiluminescent Immunometric Assay (CLIA) were performed at booking. Patients were monitored prospectively until delivery and 12 weeks postpartum. Diagnostic performance was calculated using a cut-off threshold of 35,000 mIU/mL (equivalent to >2.0 Multiple of Median [MoM]). Correlation with disease severity was evaluated using Pearson’s correlation coefficient. Results: Of the 100 enrolled participants, 91 completed complete follow-up till delivery. PIH developed in 12 cases (13.19%), while 79 (86.81%) remained normotensive. Mean second-trimester serum β-hCG levels were significantly higher in women who subsequently developed PIH compared to normotensive controls (52,144.75 ± 21,561.62 mIU/mL vs. 27,477.35 ± 12,011.03 mIU/mL, p < 0.001). Using a cut-off of 35,000 mIU/mL, elevated β-hCG yielded a sensitivity of 75.0%, specificity of 77.22%, positive predictive value (PPV) of 33.33%, negative predictive value (NPV) of 95.31%, and overall diagnostic accuracy of 76.92%. Bivariate correlation revealed a statistically significant moderate positive relationship between mid-trimester serum β-hCG levels and subsequent PIH severity (r = 0.578, p < 0.05). Conclusion: Second-trimester serum β-hCG is an effective, reliable, and non-invasive biochemical predictor for PIH. Early identification of high-risk gravidae using serum β-hCG allows for targeted clinical surveillance, timely prophylactic interventions (such as low-dose aspirin and calcium), and mitigation of severe maternal-fetal complications.

12. Cardiac Risk Factors and Cardiovascular Complications Associated with Serum Uric Acid Levels in Type 2 Diabetes Mellitus
Mahesh Reddy Patil, Pramod R. Kulkarni, Preetam
Abstract
Background and Objectives: Type 2 Diabetes Mellitus (T2DM) is a major global risk factor for cardiovascular disease. Serum uric acid (SUA) has emerged as an important prognostic biomarker linked to oxidative stress, endothelial dysfunction, and vascular inflammation. This study investigated serum uric acid levels in Type 2 Diabetic patients and evaluated their correlation with established cardiovascular risk factors and cardiac complications.
Methods: A cross-sectional observational study was conducted on 80 Type 2 Diabetic patients aged >40 years. Serum uric acid, Fasting Blood Sugar, HbA1c, lipid profile, 12-lead ECG, 2D-Echocardiography, fundoscopy, and renal/urine parameters were evaluated. Elevated serum uric acid was defined as >5.0 mg/dL. Results: Among 80 diabetic subjects (66.2% males, 33.8% females; mean age 60.2 years), 82.5% (n = 66) exhibited elevated serum uric acid (>5.0 mg/dL). SUA > 5.0 mg/dL was present in 100% of patients with diabetes duration >10 years (p = 0.005), 85.9% of hypertensive patients (p = 0.032), 96.9% of overweight/obese patients (BMI > 24 kg/m², p = 0.004), 91.5% of chronic smokers (p = 0.012), and 84.6% of patients with HbA1c > 6.5% (p = 0.029). Regarding cardiac complications, high SUA (>5.0 mg/dL) was present in 87.23% of Acute Coronary Syndrome (ACS) cases (41/47, p = 0.048), 66.67% of Congestive Cardiac Failure (CCF) cases (6/9, p = 0.048), and 50.0% of Atrial Fibrillation (AF) cases (3/6, p = 0.011). Conclusion: Elevated serum uric acid (>5.0 mg/dL) correlates strongly with cardiovascular risk factors (hypertension, high BMI, smoking, poor glycemic control, diabetes duration) and major cardiac complications (ACS, CCF, AF) in Type 2 Diabetes Mellitus. SUA > 5.0 mg/dL serves as an important red-flag risk biomarker for cardiovascular monitoring.

13. A Clinical Profile and Risk Factor Analysis of Urinary Tract Infections in Patients with Diabetes Mellitus
Mahesh Reddy, Pramod R. Kulkarni, Preetam
Abstract
Background & Objectives: Diabetes mellitus (DM) is a major global metabolic disorder associated with an increased susceptibility to severe opportunistic and recurrent infections. Among these, Urinary Tract Infections (UTIs) pose significant clinical challenges due to structural and immunological impairments. This study aimed to evaluate the clinical spectrum, associated risk factors, causative uropathogens, and antimicrobial susceptibility profiles among diabetic patients presenting with UTIs. Methods: A prospective descriptive observational study was conducted on 100 admitted diabetic patients presenting with clinical or microbiological evidence of UTI at a tertiary care medical college hospital over a 1-year period. Comprehensive clinical history, biochemical markers (FBS, PPBS, HbA1c), urinalysis, quantitative urine culture (>10^5 CFU/mL defining significant bacteriuria), renal ultrasonography, and post-void residual (PVR) urine volume evaluations were systematically performed and analyzed. Results: Out of 100 diabetic patients evaluated, 43% demonstrated significant bacteriuria while 57% were non-bacteriuric. Significant bacteriuria exhibited a strong female preponderance (62.8% vs 37.2% in males, p=0.043). Diabetic neuropathy was significantly associated with positive culture status (58.1% vs 35.1%, p=0.027). Uncontrolled glycemic status was heavily predictive of bacteriuria, with 100% of culture-positive patients having HbA1c >7.0% and 86% presenting with HbA1c >10% (p=0.0434). Leukocytosis (>12,000/mm³) was present in 30.2% of bacteriuric cases (p=0.022). Asymptomatic bacteriuria (ASB) was detected in 32.6% of bacteriuric patients. Escherichia coli was the predominant pathogen isolated (69.8%), followed by Klebsiella pneumoniae (16.2%), Enterococcus species (9.3%), Pseudomonas aeruginosa (2.3%), and Candida species (2.3%). Escherichia coli isolates exhibited highest antimicrobial sensitivity to Ampicillin, Fluoroquinolones, and Co-trimoxazole. Conclusion: Female gender, diabetic neuropathy, and severe chronic glycemic dysregulation (HbA1c >10%) serve as major predisposing factors for bacteriuria in diabetic patients. Escherichia coli remains the primary uropathogen. Routine screening for asymptomatic bacteriuria and stringent glycemic control are vital to prevent ascending upper tract complications like pyelonephritis.

14. Conservative versus Surgical Management of Rotator Cuff Tears: A Comparative Outcome Study
Arnav P. Urs, Ritesh Harwal, Sushil Kasnale
Abstract
Background: Rotator cuff tears are a common cause of shoulder pain and functional impairment. Both conservative treatment and surgical repair are widely used, although the optimal treatment varies according to patient and tear characteristics. Methods: This prospective comparative study included 120 patients with symptomatic rotator cuff tears. Sixty patients received conservative treatment and 60 underwent arthroscopic rotator cuff repair. Outcomes were evaluated using the Visual Analogue Scale (VAS), Constant–Murley Score, American Shoulder and Elbow Surgeons (ASES) score, range of motion, and patient satisfaction over 12 months. Results: Both groups demonstrated substantial improvement during follow-up. At 12 months, mean VAS scores were 2.7 ± 0.9 in the conservative group and 1.9 ± 0.8 in the surgical group (p<0.001). Mean Constant–Murley scores were 77.8 ± 7.8 and 84.1 ± 7.2, respectively (p<0.001), while corresponding ASES scores were 80.6 ± 7.5 and 87.3 ± 6.8 (p<0.001). Forward flexion, abduction, and external rotation were significantly greater after surgical treatment. Excellent/good outcomes were observed in 75.0% of conservatively treated and 88.3% of surgically treated patients. Conclusion: Both treatment approaches were effective for symptomatic rotator cuff tears. Surgical repair provided greater improvement in pain and functional outcomes at 12 months, while conservative treatment remained an effective option for appropriately selected patients.

15. Comparative Evaluation of Conventional and Augmented Fixation Techniques in Osteoporotic Fractures
Sushil Kasnale, Ritesh Harwal, Arnav P. Urs
Abstract
Background: Fixation of osteoporotic fractures is challenging because poor bone quality increases the risk of loss of reduction, implant loosening, and fixation failure. Augmentation techniques have been introduced to improve construct stability. This study compared the clinical and radiological outcomes of conventional and augmented fixation in osteoporotic fractures. Methods: This prospective comparative study included 120 patients with osteoporotic fractures requiring operative fixation. Sixty patients underwent conventional fixation and 60 underwent augmented fixation using cement and/or structural graft augmentation. Patients were followed for 12 months. Outcomes included fracture union, time to union, and maintenance of reduction, implant-related complications, functional outcome, and reoperation. Results: Mean time to union was significantly shorter following augmented fixation (15.6 ± 3.7 vs 17.8 ± 4.2 weeks; p=0.003). Union at 6 months was achieved in 96.7% of augmented and 86.7% of conventional fixation cases (p=0.048). Maintenance of reduction was significantly higher with augmentation (95.0% vs 81.7%; p=0.023). Loss of reduction (3.3% vs 13.3%; p=0.048) and screw loosening/migration (1.7% vs 11.7%; p=0.028) were significantly less frequent after augmented fixation. Overall fixation-related complications occurred in 6.7% and 21.7% of patients, respectively (p=0.019). Excellent/good functional outcomes were observed in 86.7% of augmented and 73.3% of conventional fixation cases. Conclusion: Augmented fixation provided better mechanical stability, earlier union, and fewer fixation-related complications than conventional fixation in osteoporotic fractures. It may be particularly useful in patients with poor bone quality and unstable fracture configurations.

16. Functional Outcomes Following Arthroscopic Repair of Rotator Cuff Tears in Adults
Sushil Kasnale, Ritesh Harwal, Arnav P. Urs
Abstract
Background: Rotator cuff tears are a common cause of shoulder pain and functional disability in adults. Arthroscopic repair aims to restore tendon integrity, relieve pain, and improve shoulder function. This study evaluated functional outcomes following arthroscopic rotator cuff repair in adults. Methods: This prospective observational study included 120 adult patients with symptomatic rotator cuff tears undergoing arthroscopic repair. Patients were evaluated preoperatively and followed for 12 months. Outcomes were assessed using the Visual Analogue Scale (VAS), Constant–Murley Score, American Shoulder and Elbow Surgeons (ASES) score, shoulder range of motion, repair integrity, patient satisfaction, and postoperative complications. Results: The mean VAS score decreased significantly from 7.2 ± 1.1 preoperatively to 1.6 ± 0.8 at 12 months (p<0.001). The Constant–Murley Score improved from 47.8 ± 9.4 to 87.2 ± 7.3, while the ASES score increased from 44.6 ± 10.2 to 89.1 ± 7.2 (both p<0.001). Forward flexion improved from 112.4° to 163.8°, and abduction increased from 105.6° to 158.4° (p<0.001). Excellent or good outcomes were achieved in 82.5% of patients, and 90.0% were satisfied with treatment. Repair integrity was maintained in 86.7%, while re-tear occurred in 13.3% and revision surgery was required in 2.5%. Conclusion: Arthroscopic rotator cuff repair provided significant pain relief and functional improvement with high patient satisfaction. Favorable outcomes were achieved in the majority of adults, although larger tears, older age, prolonged symptoms, and re-tear were associated with less favorable recovery.

17. Correction of Neglected Clubfoot Using the Ilizarov Frame: Radiological and Functional Outcomes
Sushil Kasnale, Arnav P. Urs, Ritesh Harwal
Abstract
Background: Neglected clubfoot is a complex rigid deformity that may be difficult to correct using conventional methods. The Ilizarov technique permits gradual correction of multiplanar deformities through controlled distraction. This study evaluated the functional and radiological outcomes following Ilizarov frame correction of neglected clubfoot. Methods: This prospective observational study included 50 patients with neglected rigid clubfoot treated using the Ilizarov external fixator. Clinical assessment included Dimeglio score, ankle range of motion, gait, pain, footwear tolerance, and achievement of a plantigrade foot. Radiological evaluation included talocalcaneal, talo–first metatarsal, tibiocalcaneal, and calcaneal pitch angles. Patients were followed for a minimum of 12 months after frame removal. Results: The mean Dimeglio score improved significantly from 15.2 ± 2.1 to 4.1 ± 1.8 (p<0.001). Ankle dorsiflexion improved from −12.6° to 8.7° (p<0.001). Significant improvement was observed in all evaluated radiological parameters. A plantigrade foot was maintained in 90.0% of patients, while 84.0% achieved excellent or good functional outcomes. Pain during walking decreased from 64.0% to 14.0%, and abnormal gait from 92.0% to 22.0%. Pin-tract infection was the most frequent complication (30.0%), while residual deformity and recurrence occurred in 10.0% and 8.0%, respectively. Conclusion: Ilizarov frame correction resulted in significant clinical, functional, and radiological improvement in neglected rigid clubfoot. Despite relatively frequent minor frame-related complications, the technique achieved a high rate of plantigrade correction and satisfactory functional outcomes.

18. Pulmonary Function Parameters across Normal Weight, Overweight, and Obese Individuals: A Comparative Analysis
Nileshwari Vala, Ravikumar Kaila, Yashpalsinh Solanki
Abstract
Background: Obesity is a well-established risk factor for cardiometabolic disease, but its impact on pulmonary function among young Indian adults — particularly at the Asia-Pacific BMI cut-offs — remains under-characterised. Aims and Objectives: To compare pulmonary function parameters — Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 s (FEV1), FEV1/FVC ratio, Peak Expiratory Flow Rate (PEFR), Forced Expiratory Flow at 25–75% (FEF25–75) and Maximum Voluntary Ventilation (MVV) — across normal-weight, overweight and obese adults, and to evaluate the correlation of BMI with each parameter. Study Design: Cross-sectional, comparative, observational study. Setting: Department of Physiology, tertiary-care teaching hospital, western India. Materials and Methods: One hundred and fifty apparently healthy adults aged 20–45 years were enrolled by purposive sampling and categorised using the Asia-Pacific WHO BMI criteria into normal-weight (18.5–22.9 kg/m²; n = 50), overweight (23.0–24.9 kg/m²; n = 50) and obese (≥25 kg/m²; n = 50) groups. Spirometry was performed following ATS/ERS 2019 standards. Anthropometry, blood pressure, oxygen saturation and respiratory rate were recorded. Statistics: One-way ANOVA with Tukey HSD post-hoc tests compared groups. Pearson correlation examined BMI–PFT relationships. Analyses were performed in IBM SPSS Statistics v26.0 with p < 0.05 as significant. Results: FVC, FEV1, PEFR, FEF25–75 and MVV declined significantly across groups (all p < 0.001). Mean FVC% predicted was 96.7 ± 5.2, 89.8 ± 6.1 and 81.4 ± 7.5 in normal-weight, overweight and obese groups, respectively (F = 73.4; p < 0.001); FEV1%predicted followed the same pattern (F = 80.9; p < 0.001). FEV1/FVC did not differ significantly (p = 0.53), indicating a predominantly restrictive pattern. BMI correlated negatively with FVC% predicted (r = −0.71), FEV1%predicted (r = −0.71), FEF25–75 (r = −0.60) and SpO2 (r = −0.36); all p < 0.001. Conclusion: Rising BMI is associated with a graded, largely restrictive impairment of pulmonary function in young Indian adults. Early spirometric screening in overweight and obese individuals may facilitate timely lifestyle intervention.

19. Emphasize Digital Transformation in Pharma: AI Integration and Compliance Benefits
R. Mahalakshmi, Gurrala Jaya Vasavi, G.P. Senthil Kumar, B. Sandhya Rani, Nalini Kunta, S. Nirmala, L. Gopi
Abstract
The pharmaceutical industry is undergoing a profound digital transformation, particularly in the realm of documentation and compliance. This review explores the evolution from traditional manual documentation to advanced digital platforms, highlighting the strategic importance of Electronic Document Management Systems (EDMS), Quality Management Systems (QMS), Laboratory Information Management Systems (LIMS), and other integrated software solutions. These systems enhance regulatory compliance, data integrity, operational efficiency, and audit readiness by automating document lifecycle management, enabling real-time access, and ensuring traceability through features like electronic signatures and audit trails. The paper contrasts manual and digital documentation practices, emphasizing the limitations of paper-based systems—such as human error, inefficiency, and security risks and the advantages of software-based approaches, including scalability, centralized access, and regulatory alignment with standards like FDA 21 CFR Part 11 and EU Annex 11. Additionally, the review examines the role of emerging technologies such as artificial intelligence, blockchain, and cloud-based SaaS models in shaping the future of pharmaceutical documentation. Case examples of widely adopted platforms like Master Control, Veeva Vault, Compliance Wire, and SAP illustrate current industry practices. The study concludes that digital documentation is not merely a technological upgrade but a strategic imperative for maintaining compliance, fostering innovation, and achieving operational excellence in a highly regulated environment.

20. Prediction of Spinal Anaesthesia-Induced Hypotension Using Perfusion Index, Pleth Variability Index and Shock Index in Patients Undergoing Lower Abdominal and Lower Limb Surgeries
Verangi Divya, Venkatesh Rongali, Kommuri Sudha
Abstract
Background: Spinal anaesthesia (SA) -induced hypotension is a common complication caused by sympathetic blockade and reduced venous return. Early prediction may permit timely preventive measures. Aim: To evaluate and compare perfusion index, pleth variability index and shock index for predicting hypotension following SA. Methods: This prospective observational study included 142 adults undergoing lower abdominal or lower limb surgery under SA at NRI Institute of Medical Sciences, Visakhapatnam, from November 2025 to May 2026. Baseline haemodynamic variables, perfusion index, pleth variability index and shock index were recorded. Hypotension was defined as a ≥20% reduction in systolic or mean arterial pressure or systolic pressure below 90 mmHg. Receiver operating characteristic analysis and multivariable logistic regression were performed. Results: Hypotension occurred in 58 patients (40.8%). Baseline perfusion index, pleth variability index and shock index were significantly higher in hypotensive patients. Perfusion index showed an AUC of 0.86 at a cut-off above 3.65, while pleth variability index showed an AUC of 0.84 at a cut-off above 16%. Shock index demonstrated modest accuracy with an AUC of 0.69. The combined model achieved an AUC of 0.91. Conclusion: Perfusion index and pleth variability index were useful non-invasive predictors, while shock index had limited independent predictive value.

21. Immunohistochemical Expression of Stem Cell Markers Sox-2 and Oct3/4 and Their Correlation with Clinicopathological Parameters in Breast Carcinoma
Swati Soni Jain, Ankit Jain, Alok Jain
Abstract
Background: The most common malignancy diagnosed in women all over the world are carcinoma of the breasts and is one of the largest cause of cancer related death. Although there have been improvements in molecular profiling and targeted therapy, there are some tumors which are aggressive and not responsive to therapy. Proposed theories The cancer stem cell (CSC) hypothesis proposes that a subpopulation of tumor-initiating cells that possess the characteristic of self- renewal and pluripotentiality propagate the progression, recurrence and metastasis of tumors. SOX-2 and OCT3/4 are transcription factors that play an important role in the maintenance of stem cells in the human embryo, and are increasingly becoming of interest in oncogenesis. In this paper, the authors tried to assess the SOX-2 and OCT3/4 immunohistochemical expression of breast cancer as well as compare its expression with clinicopathological variables and more traditional molecular features (ER, PR, HER2/neu). Methods: The study was a cross-sectional observational study catering to the requirement of 50 histopathologically confirmed cases of Invasive breast Carcinoma on female patients, National Institute of Pathology, VMMC and safdarjung Hospital, New Delhi. Paraffin embedded tissues were stained with immunohistochemistry for SOX-2 and OCT3/4. Expression was scored semi quantitatively in terms of intensity and magnitude of staining. SPSS v22 was used to do the statistical analysis. Pearson Chi-square test was used to test each correlation and values less than 0.05 were deemed significant. Results: SOX-2 and OCT3/4 were expressed in 14 percent (7/50) and 8 percent (4/50), respectively. The expression of SOX-2 was significantly correlated with lymph node involvement (p=0.016), high histological grade (p=0.034), DCIS (p=0.031), PR negativity (p=0.007) and triple negative molecular subtype (p=0.020). Increased tumor grade and metastatic recurrence to the associated regional lymph nodes (p=0.042) were significantly correlated with a positive, OCT3/4 staining phenotype but not with ER, PR or HER2/neu expression. Conclusion: High expression SOX-2 and OCT3/4 in breast carcinoma are associated with clinicopathological aggressiveness and thus are potential biomarkers of tumor aggressiveness and tumor CSC-related phenotypes. They can be further validated in larger cohort studies for improved prognostic and therapeutic value.

22. Exploring EEG Biomarkers of Cognitive Dysfunction in Polycystic Ovary Syndrome
Lakshmi Sarapalli, Sudha Jagarapu, Reddipogu Pavani, Ragam Ravi Sunder, K. Padma Leela
Abstract
Polycystic Ovary Syndrome (PCOS) and its associated cognitive dysfunction represent significant health burdens among women of reproductive age; however, reliance on traditional hormonal markers limits diagnostic precision. This analytical cross-sectional study investigated subclinical neurocognitive changes using electroencephalography (EEG) to establish novel, objective neurophysiological biomarkers in PCOS. The study comprised 55 cases and 55 healthy controls. The mean age of individuals in PCOS group is  26.5±4.8 and the mean age of individuals in control group is 26.0±5.5. The mean BMI in both the groups is near similar (PCOS=27.4±5.2 , control=27.6±6.0). In COWAT (Controlled Oral Word Association Test) Women with PCOS showed significantly lower verbal fluency scores compared to controls with a significant difference between the groups (P=0.01*). This indicates mild cognitive impairment in the PCOS group. Parietal theta power is significantly reduced in PCOS participants compared to controls, suggesting altered cognitive, as theta activity is often linked to working memory and attention (P=0.04*), whereas other parameters of EEG (Electro-Encephalo-Gram) did not show strong evidence of differences between PCOS and controls. No statistically significant alterations in relative EEG power or ratios between PCOS and control groups were found. However, trends such as slightly higher theta/alpha ratio in PCOS may indicate subtle cognitive changes. Lower theta/beta ratio in PCOS (especially at Fz) could relate to frontal cognitive processing, but further studies with larger samples are needed.

23. Relationship between Speech Rate and Communication Effectiveness in Children with Autism Spectrum Disorder: Systematic Review
Mayank Mehra, Anima Goyal, Ankita Upadhyay, Omprakash Preyadarshi
Abstract
Background: Atypical speech prosody, including variations in speech rate, is a well-documented characteristic of autism spectrum disorder (ASD). However, the specific relationship between speech rate and communication effectiveness in children with ASD remains incompletely understood, with implications for clinical assessment and intervention planning. Objective: This systematic review aimed to synthesize current evidence on the relationship between speech rate and communication effectiveness in children with ASD, examining how variations in speech rate influence intelligibility, pragmatic language skills, listener perceptions, and overall communicative success. Methods: Following PRISMA 2020 guidelines, we searched PubMed, Embase, PsycINFO, CINAHL, and Scopus databases from inception to July 2026. Studies were included if they: (1) involved children aged 3-18 years with confirmed ASD diagnosis; (2) measured speech rate acoustically or perceptually; (3) assessed at least one dimension of communication effectiveness; and (4) employed quantitative or mixed-methods designs. Risk of bias was assessed using ROBINS-I for observational studies and Cochrane RoB 2 for randomized trials. Results: From 847 initial records, 18 studies met inclusion criteria. Evidence consistently indicated that children with ASD demonstrate slower speech rates compared to neurotypical peers (mean difference: −0.42 syllables/second, 95% CI −0.68 to −0.16). Slower speech rate was significantly associated with reduced intelligibility (r = −0.41, p = 0.016), increased pragmatic language violations, and poorer listener ratings of communication quality. However, considerable heterogeneity existed across studies regarding measurement methods and participant characteristics. Speech rate emerged as the strongest acoustic predictor of listener judgments about disorder severity and social likeability. Conclusions: Speech rate represents a clinically significant marker of communication effectiveness in children with ASD. Slower rates are associated with reduced intelligibility and less favorable listener perceptions. These findings support incorporating speech rate assessment into routine clinical evaluation and considering rate modification as a potential intervention target. Standardization of measurement protocols and longitudinal research are needed to establish causal relationships and optimize clinical applications.

24. Comparative Phytochemical Profiling and in Vitro Antimicrobial Efficacy of Selective Solvent Extracts of Ziziphus xylopyrus Bark and Berberis aristata Root Extracts
Poonam Kanwar Shekhawat, Jai Singh Vaghela
Abstract
Background: Plant-derived secondary metabolites serve as valuable lead compounds in the discovery of novel antimicrobial agents. This study evaluates the extraction yield, phytochemical constituents, and in vitro antibacterial potential of selective solvent extracts from the bark of Ziziphus xylopyrus and the root of Berberis aristata. Methods: Dried plant materials (Ziziphus xylopyrus bark and Berberis aristata root) were sequentially extracted via the Soxhlet apparatus using solvents of increasing polarity, including petroleum ether and ethyl acetate (EA). Preliminary qualitative phytochemical screening was performed on all crude extracts to test for carbohydrates, alkaloids, flavonoids, glycosides, proteins, amino acids, and saponins using standard chemical assays. The antibacterial efficacy of the petroleum ether and EA extracts was assessed against Escherichia coli (Gram-negative) and Staphylococcus aureus (Gram-positive) using the agar disc/well diffusion method on prepared Nutrient Agar media. Results: The extraction process yielded distinct variations in colour, physical appearance, and weight percentage across the selective solvents for both plants. Phytochemical analysis revealed a higher concentration of flavonoids, alkaloids, and glycosides in the ethyl acetate extracts, whereas petroleum ether extracts predominantly tested positive for non-polar constituents. In the antibacterial assay, both Ziziphus xylopyrus bark and Berberis aristata root ethyl acetate extracts demonstrated notable growth inhibition against both test strains. The Berberis aristata extract showed no inhibition at 100 µg/ml, while inhibition zones increased with concentration, reaching a maximum of 10.666 ± 0.577 mm at 400 µg/ml. In contrast, the Ziziphus xylopyrus extract exhibited antibacterial activity even at the lowest concentration (7 ± 0 mm at 100 µg/ml) and showed a stronger effect at higher concentrations, with a maximum inhibition zone of 15.333 ± 1.527 mm at 400 µg/ml. Notably, Ziziphus xylopyrus exhibited activity even at 100 µg/ml, whereas Berberis aristata was ineffective at this concentration. Conclusion: The findings confirm that polar/medium-polar fractions (ethyl acetate extracts) of Ziziphus xylopyrus bark and Berberis aristata root possess significant phytochemical richness and promising broad-spectrum antibacterial activity against E. coli and S. aureus. These plant parts represent viable candidates for further isolation and structural characterisation of novel antimicrobial leads.

25. Cadaveric Study of the Branching Pattern of the Internal Iliac Artery and Its Clinical Applications
Ashok Kumar, Vimal Modi
Abstract
Background: The internal iliac artery (IIA) is the principal arterial supply of the pelvic organs, gluteal region, and perineum. Variations in its branching pattern are common and are of considerable importance during pelvic surgeries, obstetric and gynaecological procedures, urological interventions, vascular surgeries, and interventional radiology. The present study aimed to evaluate the branching pattern of the internal iliac artery according to Adachi’s classification and to determine the level of origin of the internal iliac artery in human cadavers. Materials and Methods: A descriptive cadaveric study was conducted on 60 pelvic halves obtained from 30 embalmed adult human cadavers in the Department of Anatomy of Index Medical College Hospital and Research Centre. The common iliac artery, external iliac artery, and internal iliac artery were carefully dissected. The branching pattern was classified according to Adachi’s classification (Types I–V). The level of origin of the internal iliac artery with respect to the lumbosacral vertebral level was also recorded. Results: Among 60 specimens, the common trunk of the internal iliac artery gave no branch in 27 (45%) specimens. The iliolumbar artery arose from the common trunk in 15 (25%), lateral sacral artery in 6 (10%), obturator artery in 6 (10%), superior gluteal artery in 3 (5%), and both iliolumbar and lateral sacral arteries in 3 (5%) specimens. The obturator artery originated from the anterior division in 41 (69%) specimens. From the anterior division, the internal pudendal artery was observed in 36 (60%), inferior gluteal artery in 6 (10%), internal vesical artery in 4 (7%), middle rectal artery in 3 (5%), and superior vesical artery in 2 (3%) specimens; the inferior gluteal artery was absent in 9 (15%) specimens. Conclusion: Knowledge of the branching pattern of the internal iliac artery according to Adachi’s classification and its level of origin is essential for surgeons and interventional radiologists to minimise intraoperative complications and improve the success of pelvic vascular procedures.

This journal is present in UGC approved List of Journals for the purpose of Career Advancement Scheme (CAS) and Direct Recruitment of Teachers and other academic staff as required under the UGC (Minimum Qualifications for Appointment of Teachers and other Academic Staff in Universities and Colleges)

www.ijddt.com

International Journal of Drug Delivery Technology

www.ijpcr.com

International Journal of Pharmaceutical and Clinical Research

www.ijppr.com

International Journal of Pharmacognosy and Phytochemical Research

www.ijcpr.com

International Journal of Current Pharmaceutical Review and Research

www.ijtpr.com

International Journal of Toxicological and Pharmacological Research

The publication is licensed under Creative Commons License  View Legal Published by Dr. Yashwant Research Labs Pvt. Ltd. on behalf of International Society for Science and Nature