International Journal of Basic & Clinical Pharmacology
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Antipsychotics - a key line treatment for various psychotic symptoms
Get PDF‘Psychosis’ is the state of mental disorder characterized by loss of contact with reality followed by delusions, hallucinations, disorganised thoughts etc. which mainly occurs because of the imbalance of neurotransmitters like dopamine, serotonin or glutamate. About 5-8% of people suffer from mental disorders in the whole world. In the earlier time it was difficult to treat such psychotic patients. So, when antipsychotics came in the market the treatment of such serious mental conditions became possible. Mainly two categories of antipsychotics are prescribed, out of which second generation are commonly prescribed because of their less adverse effects
A randomized, double-blind, parallel and placebo-controlled clinical study to evaluate the efficacy and safety of KaraCalm™: a dietary supplement to support sleep and manage stress
Get PDFBackground: KaraCalm™ is a novel polyherbal formulation obtained from the combination of Valeriana officinalis extract, Passiflora incarnata extract, Ocimum sanctum extract, Ziziphus jujuba extract, Rosmarinus officinalis extract, and Nigella sativa extract. The objective of the present investigation was to assess the efficacy and safety of KaraCalm™ to manage stress and improve sleep in healthy subjects in a randomized, double-blind, placebo-controlled clinical study.
Methods: A total of 60 healthy volunteers were randomized into two groups, with 30 subjects in the KaraCalm™ group and 30 in the placebo group. Participants were asked to take KaraCalm™ 500 mg or placebo once daily for 56 days. As primary outcomes, sleep analysis was performed by using Actiwatch, while stress level was evaluated with the Perceived Stress Scale (PSS) scores from baseline to the end of the study period. Serum cortisol, and hs-CRP from baseline to the end of the study period were assessed as secondary endpoints.
Results: An increase in overall sleep quality was observed in the KaraCalm™ group compared to the placebo as measured by total sleep time, onset latency, wake after sleep onset minutes, and number of awakenings. There was also a reduction in PSS scores in the KaraCalm™ group from baseline to the end of the study, indicating reduced stress levels. A significant reduction in Serum cortisol and hs-C-reactive protein (CRP) levels in the KaraCalm™ group from baseline to the end of the study further supported the effectiveness of KaraCalm™ in reducing stress. There was no significant change in the safety analyses of the patients in the intervention group when assessed from the start of the study to the end.
Conclusions: KaraCalm™ can be considered a safe and effective dietary herbal Supplement to reduce stress and improve sleep quality
Effect of long-acting supplementary local anesthetic on intra and post operative pain in single visit root canal treatment: a randomized control trial
Get PDFBackground: Patients often experience varying degrees of pain during or after root canal therapy. This study aimed to assess the effectiveness of long-acting local anesthetics, specifically Ropivacaine, in preventing intra and postoperative pain associated with endodontic treatment compared to lignocaine.
Methods: This double-blind, randomised clinical trial included 60 patients with single-rooted mandibular pre-molar teeth. Patients were divided into three groups: Group 1 received lignocaine as an inferior alveolar nerve block, Group 2 received lignocaine as an inferior alveolar nerve block with supplementary intraligamentary lignocaine, and Group 3 received lignocaine as an inferior alveolar nerve block with supplementary intraligamentary Ropivacaine. Pain levels were assessed using the visual analogue scale (VAS) before treatment, during treatment, and at 2, 6-, 12-, 24-, and 48-hours post-treatment. Statistical analysis included mean, standard deviation, Kruskal Wallis Test, Dunn's posthoc test, Chi-square, and Friedman’s test followed by Wilcoxon signed rank post hoc test.
Results: Ropivacaine as a supplementary intraligamentary anesthetic significantly reduced intraoperative pain levels at working length (p<0.001) compared to lignocaine used alone or with supplementary intraligamentary lignocaine. Group 3 exhibited statistically significant differences in postoperative pain levels at 12-hour intervals (p<0.001), correlating with reduced intake of oral analgesics (p=0.02).
Conclusions: A single dose of 0.2 ml of 0.5% Ropivacaine as a supplementary intraligamentary anaesthetic may be more effective in reducing or preventing intraoperative and post-operative endodontic pain compared to lignocaine, irrespective of the technique used
A case of generalized bullous fixed drug eruptions induced by ceftriaxone
Get PDFFixed drug eruption (FDE) is a delayed-type hypersensitivity reaction to a systemic medication. Generalized bullous fixed drug eruption (GBFDE) is a rare variant involving generalized bullae and erosions across multiple anatomical sites. A 66-year-old female with dialysis-dependent chronic kidney disease presented with fever and chills, and subsequently developed multiple erythematous to bluish annular nodules with central bullae on the hands, feet, tongue, buccal mucosa, and lips after ceftriaxone administration. Clinical examination revealed no prior history of drug allergies. Diagnostic assessments showed elevated serum creatinine and other parameters consistent with renal impairment. The suspected drug was discontinued, and patient treated with oral prednisolone, levocetirizine, topical betamethasone, and fusidic acid. Oral paste and gargles were prescribed for mucosal involvement. This case highlights the importance of recognizing ceftriaxone-induced GBFDE, particularly in patients with chronic kidney disease on haemodialysis. Prompt identification and cessation of the offending drug, along with appropriate therapeutic interventions, are critical for preventing future episodes and ensuring patient safety
Comparative evaluation of analgesic efficacy of buprenorphine transdermal patch and fentanyl transdermal patch in the management of postoperative pain after lower limb surgery
Get PDFBackground: Postoperative pain represents a significant medical issue that needs immediate attention. Despite advancements in pain management, managing postoperative pain remains challenging. Transdermal drug delivery systems (TDDS) offers a straightforward, reliable, non-invasive, and patient-friendly approach for alleviating post-surgical pain. Hence, this study was planned to evaluate the analgesic efficacy of buprenorphine and fentanyl transdermal patch in the management of post-operative pain after lower limb surgery.
Methods: In this prospective, randomised study, 82 adult patients of either sex undergoing elective lower limb surgery were randomly allocated into two groups- Group A (Transdermal Buprenorphine 20 mg patch) and Group B (Transdermal Fentanyl 50 mcg patch). Postoperative pain was assessed by 10-point Visual Analogue Scale (VAS) every 6 hours following surgery on the first day and then daily for next 4 days. All patients were also monitored for total rescue analgesic requirement, drug-related adverse effect and haemodynamic status. Statistical analysis was carried out using student t-test and Chi-square test. A p-value <0.05 was considered significant.
Results: The mean pain intensity scores were found to be significantly different (p<0.0001) between the two groups, with VAS scores consistently lower in Buprenorphine group as compared to Fentanyl group. Also, Buprenorphine group had the lowest demand for rescue analgesic, with 58.5% of patients requiring two administrations and 36.6% needing only one. Patients belonging to Fentanyl group exhibited higher occurrence of nausea (46.3%), vomiting (46.3%) and pruritus (31.7%).
Conclusions: Our study concludes that transdermal patch of buprenorphine demonstrates superior efficacy and safety profile as compared to fentanyl patch for post-operative pain management in lower limb surgeries
Is the combination of propranolol and flunarizine better than propranolol, flunarizine and amitriptyline alone in prophylaxis of migraine? An observational study at a tertiary care centre of North India
Get PDFBackground: Migraine is a primary headache disorder marked by recurrent attacks of pain and associated symptoms. Propranolol is traditionally considered highly effective for migraine prophylaxis, but other drugs have recently shown promise.
Methods: This study was a prospective, observational, randomized, parallel-arm, unicentric trial conducted in the neurology department of a tertiary care hospital in North India. Patients with migraine without aura were randomly assigned to one of four treatment groups. After obtaining consent, patients were randomized using a random number table. Group 1 received propranolol (80 mg), group 2 received flunarizine (10 mg), group 3 received a combination of propranolol (40 mg) and flunarizine (10 mg), and group 4 received amitriptyline (10 mg) daily. The primary outcome was a change in the frequency of migraine days, while secondary outcomes included changes in moderate-to-severe headache days and disability levels.
Results: The combination of propranolol (40 mg) and flunarizine (10 mg) was significantly more effective in reducing the frequency of migraine attacks at the end of 3 months compared to the group receiving amitriptyline (10 mg). However, no significant differences between the groups were observed at baseline, 1 month, and 2 months. For other outcomes, including adverse drug reactions (ADRs), there were no significant differences between the groups.
Conclusions: The combination of propranolol (40 mg) and flunarizine (10 mg) demonstrated superior efficacy over amitriptyline (10 mg) after prolonged treatment, while its effectiveness was comparable to other groups at earlier time points. ADRs were similar across all groups
Assessment of risk factors, complications and treatment patterns of diabetic patients in India
Get PDFBackground: Early identification of risk factors and comorbidities is essential for optimizing treatment strategies in diabetes. The diabetes in India (DIAB India) study aims to evaluate risk factors, glycemic status, comorbidities, and initial management choices in newly diagnosed T2DM
Methods: A retrospective, observational, multicenter study was conducted with a large cohort of 19,230 patients pan India. Data was collected from patient health records and meticulously stored into a standard format. Demographic data (age, gender, weight, height, risk factors, and blood pressure), clinical presentation (family history, complications, glycemic indices, and comorbidities), and choice of management were recorded and used for analysis.
Results: Obesity and family history were most common risk factors for T2DM and were significantly correlated with its severity (p<0.001). The most common comorbidity was neuropathy (59.8%) followed by nephropathy (27%) and CV events (25%). Obese patients have higher mean hemoglobin A1c (HbA1c) of 8.4%, fasting blood glucose (FBG) (160 mg/dL), and postprandial blood glucose (PPBG) (233.6 mg/dL) compared to non-obese. Both single and combination therapies led to significant improvements in HbA1c (Single: pre- 7.47, post-6.87; Combination: pre-8.26, post-7.13), FBG (Single: pre-138.94, post-118.89; Combination: pre-161.21, post-128.2), and PPBG (Single: pre-200.88, post-163.83; Combination: pre-235.10, post-177.87) levels after treatment, with combination therapy showing greater reductions across all markers (p<0.001). The improvement in glycemic control was greater in patients who followed dietary advice (p<0.001).
Conclusions: Obesity and family history were the most common risk factors contributing to diabetes in the newly diagnosed Indian patients. The comorbidities usually associated with diabetes are identified as neuropathy and cardiovascular conditions. While dietary measures are not widely used, significant improvement in glycemic status is reported using pharmacotherapy (monotherapy or combination). Choice of pharmacological and non-pharmacological treatments should be tailored to patient preferences, demographics, comorbidities, age, and other factors
Retracted: A comparative study of propranolol versus amitriptyline at a low dose for prophylaxis of episodic migraine at a tertiary care centre
Get PDFThe article "A comparative study of propranolol versus amitriptyline at a low dose for prophylaxis of episodic migraine at a tertiary care centre" has been retracted by the Editor-in-Chief due to violations of the policies and practices of the International Journal of Basic & Clinical Pharmacology. The retraction follows a complaint from the study institution regarding the presentation of false information in the study details, issues with ethical approval, and discrepancies in authorship
Impact of ayurvedic panchakarma along with lifestyle modification in restoring glucose tolerance in type 2 diabetics
Get PDFBackground: Diabetes mellitus is an increasing global concern. There is limited published literature documenting the effectiveness of Ayurveda interventions for this condition. Aim of the study was to evaluate the effect of the comprehensive diabetes care (CDC) program on glycosylated hemoglobin (HbA1c), body mass index (BMI), body weight, abdominal girth, and dependency om conventional medication in patients with diabetes mellitus.
Methods: A retrospective, observational, single centre study was conducted at Madhavbaug clinic, India from August 2021 to March 2023. Patients aged 18 years and above with a diagnosis of diabetes mellitus were included in this study. Follow-up was conducted at day 1, 30, 60, and 90.
Results: A total of 39 patients were assessed, of which 18 (46.2%) patients were male. The mean HbA1c levels at day 1, 30, 60, and 90 for the 12 patients with HbA1c<6.5 was 6.23±0.24%, 5.75±0.41%, 5.60±0.33%, and 5.65±0.30%, respectively. The mean HbA1c levels at day 1, 30, 60, and 90 for the 22 patients with HbA1c 6.6-9.0 was 7.14±0.48%, 6.46±0.62%, 6.22±0.59%, and 6.12±0.42%, respectively. The mean HbA1c levels at day 1, 30, 60, and 90 for the 3 patients with HbA1c >9.0 was 10.30±0.45%, 9.10±1.20%, 7.30±1.50%, and 7.15±0.65%, respectively.
Conclusions: Ayurvedic panchakarma along with lifestyle modification is successful in restoring the glucose tolerance in type 2 diabetic patients
Assessment of drug therapy problems among hypertensive patients at integral institute of medical science and research
Get PDFBackground: Drug therapy problems (DTP) encompass a range of categories. These include untreated indications, overdose, wrong choice of drugs, adverse drug reaction, drug-drug interaction, need for monitoring, and non-adherence etc. by recognizing and addressing these various drug related problems, healthcare professionals can optimize treatment outcomes and ensure patient safety. Aim was to assess DTP among hypertensive patients at IIMS&R hospital
Methods: Over a period of six months, a prospective observational study involving 107 subjects was conducted at IIMS&R hospital, Lucknow department of general medicine. Information about patient demographics, co-morbidities, and drug therapy problems in treatment of hypertension were collected and analyzed, and the results were expressed as percentages.
Results: In the study, 12 different types of antihypertensive medications were prescribed in a total of 225 drugs. Telmisartan, amlodipine, torsemide, and furosemide emerged as the most commonly prescribed medications. Telmisartan was frequently prescribed orally, while furosemide was primarily administered intravenously. Drug therapy problems such as untreated indication, lack of patient compliance, adverse drug reactions (ADRs) and potential interactions were found
Conclusions: The study highlighted the importance of monitoring and addressing potential drug interactions, medication adherence were common drug therapy problems. This underscores the immediate need for health education and sensitization initiatives targeted at individuals with hypertension, aiming to improve the overall quality of life for these patients