International Journal of

Pharmaceutical Quality Assurance

e-ISSN: 0975 9506

p-ISSN: 2961-6093

Peer Review Journal

Impact Score 3.213

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1. Impact of Bacterial Infection on Skin Graft Outcomes in Leg Ulcers
Digant Shikotara, Vijay Vasantlal Paria
Abstract
Background: Chronic leg ulcers often present with bacterial colonization, which can interfere with the success of skin grafting procedures. The presence of comorbidities such as diabetes and advanced age further complicates wound healing and graft integration. Aim: To estimate the impact of bacterial colonization on the success rate of skin grafts in leg ulcers and to evaluate the modifying effects of diabetes and age on wound healing. Materials and Methods: This observational study included 60 patients undergoing split-thickness skin grafting for leg ulcers. Wound swabs were collected prior to grafting for aerobic bacterial culture. Participants were categorized based on colonization status, diabetes presence, and age groups. Graft uptake was clinically assessed on postoperative day 7 and 14. Data were analyzed using descriptive statistics and independent t-tests, with p < 0.05 considered statistically significant. Results: The most common isolate was Staphylococcus aureus (45%), followed by Klebsiella and Acinetobacter. Culture-negative wounds showed relatively better graft uptake. Diabetic patients exhibited lower mean graft take (76.4%) compared to non-diabetics (83.2%), though the difference was not statistically significant (p = 0.120). Infection was the leading cause of ulcers (48.3%), and males were predominantly affected (66.7%). Conclusion: Bacterial colonization, especially with S. aureus, negatively impacts graft success in chronic leg ulcers. Diabetes may further impair graft uptake. These findings highlight the importance of microbiological evaluation and glycemic control prior to surgical grafting to optimize wound healing outcomes.

2. Placental Pathology in Preeclampsia and Eclampsia and its Impact on Pregnancy Outcome-A Cross Sectional Study in a Tertiary Care Centre in Assam, India
Radha Rashmi Baruah, Usha Sarma, Akash Pradeep Bhuyan, Pitambar Baishya
Abstract
Background: Preeclampsia and eclampsia are significant hypertensive disorders during pregnancy, contributing notably to maternal and neonatal morbidity and mortality worldwide. In India, the incidence of preeclampsia is estimated to be 7 times higher as compared to global range. Knowledge of the placental pathology in these cases is of utmost significance in understanding its pathogenesis. However, no relevant studies were done in this north eastern region of India. Aims and Objectives: To study the spectrum of histopathological changes in the placenta in patients of Pre-eclampsia and Eclampsia. To see the outcome of pregnancies associated with Pre-eclampsia and Eclampsia. Materials and Methods: This cross-sectional analytical study was conducted in the Department of Obstetrics & Gynaecology and the Department of Pathology, Tezpur Medical College over a period of two years from January 2019 to December 2020. Detailed clinical and laboratory evaluation was done in each of the patient. After delivery their placentas were sent for histopathological examination and results were recorded. Results: A total of 120 pregnancies, comprising of 40 cases each of Pre-eclampsia, eclampsia and normal pregnancies were evaluated. Mean gestational age at delivery was found to be 36 weeks and 32 weeks in Pre-eclampsia and Eclampsia group respectively. 55% of newborns were found to be low birth weight in eclampsia as compared to 7.5% in normotensive control groups. The mean placental weight was statistically reduced (p<0.001) in pre-eclampsia and eclampsia groups as compared to control group. Placental necrosis was found to be the most common histopathological features in both preeclampsia (75%) and eclampsia (100%). Other changes include increased syncytitial knots, perivillous fibrin deposit, calcification, hypertrophy of spiral arterioles. Conclusion: Hypertensive disorders of pregnancies are associated with significant pathological changes in the placenta and has significant effect in the pregnancy outcome.

3. Comparison of Possum & P-Possum Scores in Predicting Mortality Among Patients Undergoing Emergency Abdominal Surgery
Himen Baidya, Damodar Chatterjee, Diptendu Chaudhuri
Abstract
Introduction: Laparotomies are among the most common surgical procedures.  It is widely acknowledged that patients in these situations have bad outcomes.  Although emergency laparotomies are among the most frequently performed urgent surgical operations, little is known about their results.  The post-operative mortality rate for peritonitis is still high, currently estimated to be between 14.9 to 19.4%, despite countless advancements in surgical techniques, antimicrobial medications, and supportive care. Aims: To compare POSSUM and P-POSSUM scoring in predicting mortality in patients undergoing emergency abdominal surgery. Materials & Methods: Prospective study. Department of General Surgery, Agartala Government Medical College, Agartala, West Tripura from December 2019 to June 2022 and total sample size 150 patients. Result: The average Possum score (mean± s.d.) for patients who died was 92.7000± 5.8678. The mean Possum score (mean± s.d.) for patients who survived was 35.4343± 19.6384. The mean Possum score and outcome distribution was statistically significant (p<0.0001). Conclusion: We came to the conclusion that POSSUM and P-POSSUM scores are statistically significant predictors of death (p < 0.0001 for both) for patients undergoing emergency abdominal surgery at AGMC & GBP Hospital.   The mean scores of patients who expired were substantially higher than those of survivors (POSSUM: 35.4, P-POSSUM: 18.9).

4. Study Comparing Quality of Life between Mitral Valve Repair and Mitral Valve Replacement
Suranjan Haldar, Haripada Das, Ashis Halder, Debabrata Biswas
Abstract
Objectives: Among the Vulvular heart diseases, Mitral valve disease is the most frequent form of Vulvular heart diseases leading to cardiovascular morbidity and mortality globally. Mitral valve repair (MVr) has gained more attention since mitral valve replacement (MVR) is associated with some critical complications. The present study was conducted to evaluate and compare MV repair and replacement on recovery from surgery, with a focus on postoperative quality of life and health status over one year of follow up period. Methods: The present descriptive observational study with prospective design was conducted at a tertiary level healthcare institute in the city of Kolkata, West Bengal, over a period of one year. A total of 65 patients with mitral regurgitation admitted for mitral valve surgery in the department of Cardio-thoracic and Vascular surgery at the institute were interviewed using a pre-tested and pre-designed schedule and observing and recording the clinical variables after obtaining the ethical clearance from the institute and informed consent from each subject. Quality of life was evaluated with the Medical Outcomes Trust Short-Form 36-item Health Survey (SF-36) scale. Inferential statistics either by parametric or non-parametric tests according to the data distribution for continuous variables and Chi-square test categorical variables was performed to elicit association; p value of less than 0.05 was considered statistically significant. Results: The mean age (SD) of the study population among MV repair was 53.4 (±12.4) years and among MV replacement was 57.2 (±11.6) years. There was a gradual improvement in the NYHA functional class from baseline to 12 months follow-up time for both treatment groups. The mean value of various parameters of the SF-36 scores increased more among the patients of MV repair than replacement over one year of follow up period. Conclusion: There was marked and significant improvement in parameters like Physical function, Role limitation, Bodily Pain, General health and Social function among the patients with MV repair than replacement.

5. Study of Laparoscopic Tubal Sterilization Reversal and Fertility Outcomes
Kamal Prasad Agarwalla, Rahul Agrawal, Satyajit Samal, Nirod Kumar Sahoo
Abstract
Background: Although there are many different contraceptive methods available, tubal ligation is now the most common one. It plays a significant role in India’s National Family Planning Programme. Tubal sterilization techniques range from laparoscopic sterilization to traditional Pomeroy’s fimbriectomy depending on the level of expertise available. 1% to 3% of these women later ask to have their sterilization reversed, even though it is done as a permanent technique of sterilization. . Many western centres have showed success using improved laparoscopic methods, and this is now commonly considered as a substitute method for carrying out microsurgical reversal of a ligated tube. Purpose: The study had two objectives. First, it was determined whether the tubal recanalization was appropriate and what circumstances would lead to a successful laparoscopic recanalization. The second goal was to examine how laparoscopic tubal recanalization affected reproductive results and pregnancy rates. Methods: 43 women who were prospectively monitored and sought tubal sterilization reversal at a tertiary care facility between May 2015 and February 2020 were included in a retrospective chart assessment. Results: Only 14 unilateral tubes were suitable and in 2 women bilateral tubes were suitable. For recanalization, all patients requiring laparoscopic tubal sterilization were suitable, whereas all cases requiring fimbriectomy were not. Salpingostomy was used as an alternative to tubal re anastomosis in 10 (23.25%) cases. Pregnancy rates were 58.8% overall. 4 out of 12 women who had sterilization using Pomeroy’s procedure became pregnant, compared to 5 out of 8 women who underwent laparoscopic tubal ligation (P=0.24). No patients with a final tubal length of less than 5 cm became pregnant (P=0.042). When comparing the age at recanalization, 82.3% of women less than 30 years old conceived, compared to 45% of women over 30 years old. Conclusions: Sterilization method and the length of the tube after recanalization are significant determinants of recanalization success. Gynaecologists must sterilize patients with minimal stress while also minimizing failure rates. They must also work to maintain the length of the tube so that, should the patient’s circumstances alter, reversal is more likely to be successful.

6. Fecal Calprotectin Level as the Early Indication of Inflammatory Bowel Disease
Partha Pratim Dey
Abstract
Introduction: Lower bowel symptoms, including chronic abdominal pain or discomfort with diarrhea or constipation, are common presenting features in both primary and secondary care settings. These symptoms may be caused by a number of different conditions, including inflammatory bowel disease (IBD), of which ulcerative colitis (UC) and Crohn’s disease (CD) are the most common, and irritable bowel syndrome (IBS). Aims: To evaluate the utility of fecal calprotectin (FC) levels as an early indicator for diagnosing inflammatory bowel disease (IBD) and differentiating it from other gastrointestinal disorders. Materials & Methods: The present study was a Observational, cross-sectional study. This Study was conducted from One year January 2024- December 2024 at department of General Medicine, Murshidabad Medical College & Hospital, Station Road, Berhampore, Murshidabad, West Bengal, Pin-742101. Total 50 patients were included in this study. Result: Endoscopic findings revealed a correlation between the severity of inflammation and mean fecal calprotectin (FC) levels. Patients with normal endoscopic results (n=10) had a mean FC level of 45.2 μg/g, while those with mild inflammation (n=14) showed a mean of 165.3 μg/g. Moderate inflammation was observed in 16 patients with a mean FC level of 325.5 μg/g, and severe inflammation was present in 10 patients, who had the highest mean FC level of 487.7 μg/g. Conclusion: We concluded that, fecal calprotectin (FC) has proven to be a valuable non-invasive biomarker for the early detection of inflammatory bowel disease (IBD). This study demonstrated a strong correlation between elevated FC levels and both endoscopic severity and confirmed IBD diagnoses, particularly in cases of ulcerative colitis and Crohn’s disease.

7. Ankle-Brachial Index (ABI) is Useful for Diagnostic Purpose and Predicting Peripheral Artery Disease (PAD)
Partha Pratim Dey
Abstract
Introduction: Peripheral artery disease (PAD) is a common manifestation of systemic atherosclerosis and is associated with significant morbidity and mortality. The ankle-brachial index (ABI) is a simple, noninvasive tool used to diagnose PAD. This study evaluates the utility of both traditional and alternative ABI calculation methods in diagnosing PAD and predicting long-term mortality outcomes. Aims: To evaluate the diagnostic utility of the Ankle-Brachial Index (ABI) in identifying Peripheral Artery Disease (PAD) using both traditional and alternative calculation methods. Materials and Methods: This was an observational, cross-sectional study. This Study was conducted from One year January 2024- December 2024 at department of General Medicine, Murshidabad Medical College & Hospital, Station Road, Berhampore, Murshidabad, West Bengal, Pin-742101. A total of 120 patients were included in the study. Results: The prevalence of PAD was 16.7% using the traditional ABI and 37.5% using the alternative ABI method. Compared to the no-PAD group, both the traditional-PAD and alternative-PAD groups showed significantly higher all-cause and cardiovascular mortality. The C-index for cardiovascular mortality prediction was significantly higher with the alternative method (0.665; 95% CI: 0.595–0.734) compared to the traditional method (0.575; 95% CI: 0.508–0.641; p=0.013). Patients with severely decreased ABI (<0.40) in either method had over a threefold increased risk of death. Conclusion: The ABI is a valuable diagnostic and prognostic tool for PAD. The alternative ABI method improves identification of high-risk individuals and provides superior predictive capacity for mortality compared to the traditional method. These findings support broader implementation of alternative ABI in clinical practice for better risk stratification.

8. Green Assessment of Analytical Procedure for the Determination of Anti-Hypertensive Drugs by HPLC
Priyanka Malani, Vineet C. Jain, Zarna Dedania
Abstract
Background: The objective of the proposed study was to develop and validate a stability-indicating greener chromatographic method for the simultaneous analysis of anti-hypertensives drugs for amlodipine besylate (AML) and folic acid (FOL) in synthetic mixtures , assessing its environmental impact using various greenness evaluation tools — an emerging advancement in the field of analytical chemistry. AML, a calcium channel blocker used for hypertension management, is currently under investigation in Phase III clinical trials (CN111481554A) in combination with FOL. This combination has demonstrated potential for enhanced blood pressure reduction, reduced cardiovascular and cerebrovascular risk, and improved protection of vital organs, including the heart, brain, and kidneys. Methods: Chromatographic separation was achieved using a Shimadzu P-series C18 column (250 mm × 4.6 mm, 5 µm particle size). The mobile phase, consisting of methanol, acetonitrile, and buffer (adjusted to pH 3.5 using orthophosphoric acid) in a 30:50:20 (v/v/v) ratio, was delivered at a flow rate of 1.0 mL/min. Detection was carried out at a wavelength of 235 nm using a PDA detector. The method validation was performed according to ICH Q2 (R2) guidelines. Forced degradation studies were conducted under acidic (0.1N HCl), alkaline (0.1N NaOH), oxidative (3% H₂O₂), thermal (60°C for 3 hours), and photolytic (UV light exposure) conditions. Results and Discussion: Retention times were recorded as 2.011 minutes for AML and 4.019 minutes for FOL. The method exhibited linear calibration curves over the concentration ranges of 50–300 µg/mL for AML and 8–48 µg/mL for FOL, with correlation coefficients (R²) of 0.9967 and 0.9975, respectively. Sensitivity was demonstrated through low detection and quantification limits. Accuracy and precision were within acceptable limits, and the results were reproducible. Forced degradation studies indicated significant degradation under acidic, alkaline, and oxidative conditions, while thermal and photolytic conditions induced comparatively minor degradation. This validated method is suitable for stability and simultaneous quantification studies of AML and FOL in pharmaceutical formulations. Assessment of method was carried out using the two different tools. The developed method is anticipated to be eco-friendly, alternative to developed method in regard to safe solvent, less toxic and less run time. Conclusion: The stability-indicating method is reliable and ideal for routine analysis and stability studies in quality control lab user greener solvent.

9. Symptomatology and Hemodynamic Trends in Dengue Fever: An Observational Study
Kyada Rutvi Mukeshbhai, Bhojani Mansi Rajeshbhai, Vaghani Prakruti Alkeshbhai, Sojitra Sahil Chandulal
Abstract
Background: Dengue is a mosquito-borne viral infection posing significant public health challenges, particularly in tropical and subtropical regions. It presents with a range of clinical symptoms, from mild fever to severe complications, and early diagnosis and monitoring are crucial to reduce morbidity and mortality. Objectives: This study aimed to analyze the clinical presentation and hematological parameters of patients diagnosed with dengue fever admitted to a tertiary care hospital over a one-year period. Methods: A total of 105 patients diagnosed with dengue fever were included in this observational study conducted from April 2024 to March 2025. Clinical symptoms, pulse rate, and platelet counts were recorded and analyzed. Data collection was performed at a tertiary care hospital with standardized diagnostic criteria. Results: Fever was the most common symptom, reported in 100 patients, followed by vomiting (43), headache (18), and abdominal pain (14), with fewer cases of body ache, malaise, joint pain, rashes, and diarrhoea. Most patients (63) had a pulse rate between 61–100 bpm, while 25 had rates between 41–60 bpm, 14 had rates over 100 bpm, and 3 were below 40 bpm. Platelet counts were notably reduced in many cases, with 36 patients showing levels below 50,000/µL and 39 between 50,000–100,000/µL. Discussion: The findings show that fever and vomiting are common in dengue, with many patients experiencing thrombocytopenia. Monitoring platelet counts and pulse rate is vital for effective management and preventing complications.

10. Evaluation of Medication Adherence Practices among Patients Attending Non-Communicable Diseases OPD – A Cross-Sectional, Questionnaire-Based Study in a Tertiary Care Hospital
Annapurna D., Santhi Lakshmi CH, Suresh Babu N., Sirisha N.P.
Abstract
Aim: This study aimed to measure medication non-adherence and to assess the perceived barriers, and facilitators. Objectives: (1). To measure the rate of medication non-adherence. (2). To assess medication-taking behaviors, attitudes towards medication adherence, and reasons for non-adherence. Study design: The MARS questionnaire was used in this cross-sectional study, which was conducted in the non-communicable diseases department of a tertiary care hospital in Vizianagaram After the evaluation, patients and referring clinicians received a report that included tailored suggestions for lifestyle, psychological, and pharmaceutical therapies. Study Sample Size: During the study period from October 2024 to December 2024, a total of 306 fully completed questionnaires from outpatients visiting our GGH’s non-communicable diseases department were obtained. Descriptive statistics were used for review and analysis. Results: Descriptive statistics were used to analyze the 306 completed questionnaires received throughout the study period. Over half (51%) of the participants were men. The patient’s average age was 56.8 years. The MARS Questionnaire states that a score of greater than six denotes good medication adherence, while a score of less than six denotes poor medication adherence. Of the 306 participants, 282 received a rating higher than six. The majority of study participants (92.15%) generally adhered to their drug regimens well, although 7.84 percent showed poor medication adherence. Conclusion: The majority of patients with chronic non-communicable disorders (92.15%) in this study had good drug adherence. Patients’ medication adherence was found to be influenced by their personal opinions; those who strongly believed that medications were necessary were less likely to have poor medication adherence. Potential contributing factors for medication adherence include age, disease stage, severity of sickness, and income stability.

11. A Comparative Study between Propofol and Dexmedetomidine for the Reduction of Etomidate Induced Myoclonus in Patients Undergoing General Anesthesia for Supra Umbilical Surgery
Debjani Basu, Avijit Dutta, Archana Roy, Dipankar Mukherjee, Soumya Adhya
Abstract
Introduction: General anesthesia has been the gold standard and backup form of anesthesia for all surgical procedures since the beginning of anesthesia, when it was a field with few resources and equipment. The well-known induction medication etomidate, is used extensively for  induction and has a better stable cardiovascular profile with fewer respiratory adverse effects than propofol. Despite being regarded as a safe induction drug with a little risk of hypotension, etomidate has two common side effects: myoclonus and injection pain. Aims: A comparative study between dexmedetomidine and propofol in reduction of etomidate induced myoclonus in patients undergoing general anesthesia for supraumbilical surgery. Materials & Methods: This is a prospective, comparative, observational study. Place of study and Duration: Nil Ratan Sircar Medical College and Hospital, Kolkata, West Bengal. This study was conducted over a period of 18-month (Jan 2019- July 2020) and total sample size 80 patients. Result: In our study mean duration of myoclonus at first, second, and third minutes of our investigation revealed significant difference between the ED (Dexmedetomidine group) and EP (Propofol group).  The mean duration of myoclonus at first, second, and third minute readings of ED were 1.675, 1.425, and 1.15, respectively.  At EP, on the other hand, there was a notable rise to 3.975 in the first minute, a little rise to 1.625 in the second, and a fall to 0.7 in the third.  These findings point to a noticeable initial peak in the first minute at EP, which was followed by a slow drop in the minutes that followed. There is also notable early increase in symptom severity at EP1, followed by a significant reduction in symptoms by EP3. Conclusion:  The study led us to conclude that both propofol and dexmedetomidine are effective in reducing the incidence and severity of etomidate-induced myoclonus in patients undergoing general anesthesia for supra-umbilical procedures. However, dexmedetomidine had a stronger effect than propofol, with increased hemodynamic stability and a significantly lower incidence of myoclonus.

12. A Comparative Study between Propofol and Dexmedetomidine for the Reduction of Etomidate Induced Myoclonus in Patients Undergoing General Anesthesia for Supra Umbilical Surgery
Debjani Basu, Avijit Dutta, Archana Roy, Dipankar Mukherjee, Soumya Adhya
Abstract
Introduction: General anesthesia has been the gold standard and backup form of anesthesia for all surgical procedures since the beginning of anesthesia, when it was a field with few resources and equipment. The well-known induction medication etomidate, is used extensively for  induction and has a better stable cardiovascular profile with fewer respiratory adverse effects than propofol. Despite being regarded as a safe induction drug with a little risk of hypotension, etomidate has two common side effects: myoclonus and injection pain. Aims: A comparative study between dexmedetomidine and propofol in reduction of etomidate induced myoclonus in patients undergoing general anesthesia for supraumbilical surgery. Materials & Methods: This is a prospective, comparative, observational study. Place of study and Duration: Nil Ratan Sircar Medical College and Hospital, Kolkata, West Bengal. This study was conducted over a period of 18-month (Jan 2019- July 2020) and total sample size 80 patients. Result: In our study mean duration of myoclonus at first, second, and third minutes of our investigation revealed significant difference between the ED (Dexmedetomidine group) and EP (Propofol group).  The mean duration of myoclonus at first, second, and third minute readings of ED were 1.675, 1.425, and 1.15, respectively.  At EP, on the other hand, there was a notable rise to 3.975 in the first minute, a little rise to 1.625 in the second, and a fall to 0.7 in the third.  These findings point to a noticeable initial peak in the first minute at EP, which was followed by a slow drop in the minutes that followed. There is also notable early increase in symptom severity at EP1, followed by a significant reduction in symptoms by EP3. Conclusion:  The study led us to conclude that both propofol and dexmedetomidine are effective in reducing the incidence and severity of etomidate-induced myoclonus in patients undergoing general anesthesia for supra-umbilical procedures. However, dexmedetomidine had a stronger effect than propofol, with increased hemodynamic stability and a significantly lower incidence of myoclonus.

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