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Background Objectives: A 2.5-year placebo controlled double blind trial was conducted to investigate the safety and efficacy of AYUSH- SL, a poly- herbal Ayurvedic formulation on filarial lymphedema in different endemic areas of India. Lymphatic filariasis (LF) is caused by parasitic nematodes from Wuchereria bancrofti, Brugia malayi, or B. timori that are transmitted through mosquitoes. In Ayurveda, LF has been elaborately narrated under the heading Shlipada, and the literature also includes detailed therapeutic measures., Methods: The multicenter, prospective, parallel group interventional study of a total of 180 participants were recruited within the duration through competitive enrollment. Diagnosed cases of grade I and grade II filarial lymphedema of Grade I and Grade II (lower extremities) were included in the trial. The study group was treated with MDA and AYUSH-SL or its placebo tablet., Results: The control group had received MDA and a matching placebo. The primary outcome measure was the reduction in edema calculated for analysis by percentage reduction from baseline at the 4th, 12th and 24th week. Secondary outcome measures included improved quality of life (QoL), which was assessed using the Lymphatic Filariasis Specific QoL Questionnaire, and prevention of recurrence of acute episodes, which was evaluated by investigating the presence and severity of episodes in the past 4 weeks. The water displacement method for the evaluation of the efficacy of the intervention was shown to be highly significant compared to the baseline value (right leg; 3071.60 ± 970.482, 2828.40±829.339, p<0.001and Left leg; 3158.69 ± 1136.391, 2890.73 ±1077.475, p<0.001)., Interpretation Conclusion: There was significant improvement of Quality of Life in the LF QoL Questionnaire (p <0.001) at each follow-up visit in both groups. Safety estimations on hematologic and biochemical parameters were within limits and or changes were not significant. The results revealed that AYUSH- SL is safe and effective for FL due to its comprehensive anti-inflammatory, antimicrobial, and anti-allergic activities., (Copyright © 2024 Journal of Vector Borne Diseases.)

Background & objectives Although multi-drug therapy has decreased the burden of disease, leprosy is yet to be eliminated. Accelerating progress requires optimal use of existing tools, advanced diagnostic tests, newer drugs, and vaccines. The search for a vaccine with therapeutic and preventive potential is ongoing, but evidence on effectiveness and safety is lacking. This systematic review and meta-analysis will evaluate and compare the clinical efficacy, immunogenicity, and safety of leprosy vaccines in humans. Methods In June 2024, three databases were systematically searched with updated search keywords. Randomized controlled trials (RCTs) pertaining to leprosy vaccines for humans which evaluated either therapeutic or prophylactic vaccines in leprosy with a placebo or active comparator arm, with full-text access, were included in the study. There were no restrictions on language, country or date. For the risk of bias assessment in the studies included, the revised Cochrane risk-of-bias 2 tool for RCTs was used. A P value (two-sided) of <0.05 was considered as significant for all tests; however for heterogeneity, a one-sided P value of <0.1 was considered as statistically significant. The quality of generated evidence specific to the desired outcomes were assessed using the GRADE approach (Grading of Recommendations Assessment, Development and Evaluation). The study protocol was registered in PROSPERO (ID: CRD42024561651). Results A total of 2163 studies were retrieved from different databases. After removing duplicates and full text screening, 12 articles were finally selected. Out of these studies, eight used leprosy vaccines on prophylactic basis, while four used leprosy vaccines on therapeutic basis. In therapeutic use of leprosy vaccine, Ramu's score was found to be significantly protective [-3.06 (95% confidence interval (CI): -3.96 to -2.16)] among the recipients of the therapeutic leprosy vaccine. Bacterial index was found to be insignificant [-0.26 (95% CI: -1.54 to 1.03)] among the recipients of therapeutic leprosy vaccine. In subgroup analysis among the eight prophylactic vaccine studies, pooled relative risk was found to be 0.61 (95% CI: 0.41 - 0.91). Interpretation & conclusions The findings of this meta-analysis suggest that both prophylactic and therapeutic leprosy vaccines were significantly better compared to the placebo. Leprosy vaccine in the form of Mw/Mycobacterium welchii/MIP along with combination of World Health Organization (WHO) multi-drug therapy (MDT) or Bacillus Calmette-Guerin (BCG) vaccine along with second line treatment with rifampicin were found to be protective among the recipients.

Introduction: Self-medication behavior appears to be a commonplace; and when it is ignorant it may prove dangerous. On the other hand, dispensing errors and consequent adverse outcomes, though not too uncommon, are seldom reported. We report here a case of methotrexateinduced acute vesico-bullous eruptions in a patient of psoriasis who indulged in self-medication and was wrongfully dispensed higher doses of methotrexate., Case Description: A 50-year-old man was diagnosed with psoriasis two years back and advised tablet methotrexate 20 mg once weekly and folic acid supplementation. He experienced symptoms remission after 8 weeks of treatment and preferred to discontinue the medication. As the psoriatic lesions reappeared four weeks ago, he attended a retail pharmacy for refill of the two-year old prescription. He was obliged by the man in the counter who wrongfully dispensed the medicine and the patient consumed methotrexate 10 mg twice daily. On the 20th days, the patient experienced erythematous, vesico-bullous lesions spread all over the body including both limbs and scalp, with oral mucosal involvement without any history of fever, and with mildly deranged liver function, and presented to the dermatology OPD of a tertiary hospital. He was admitted and treated with injection glucocorticoid and leucovorin. He responded well and completely recovered in a week. A 'probable' causality was adjudged for this serious adverse event by both WHO-UMC scale and Naranjo's algorithm. The reaction was moderately severe (Hartwig's scale) and it was definitively preventable (modified Schumock-Thornton scale)., Conclusion: This case report highlights the hazard of uninformed Self-medication and irresponsible dispensing behavior resulting in serious drug-related injury., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.)

Background: Post-partum haemorrhage (PPH) is a major cause of maternal mortality globally. Tranexamic acid, an anti-fibrinolytic agent, is a novel approach in an attempt to prevent this dreadful complication. This study aims to document the efficacy of intravenous (IV) tranexamic acid in reducing blood loss during and after caesarean section (CS)., Methods: In this prospective randomised placebo-controlled open-label study, 100 mothers scheduled for elective CS were randomly selected and divided into two groups (study and control) of 50 each. The study group received 1 g IV tranexamic acid and the control group received IV placebo. Following delivery, all mothers received ten units of oxytocin in 500 ml of normal saline., Results: The mean intra-operative and post-partum blood loss were significantly lower in the study group than the control group: 499.11 ± 111.2 and 59.93 ± 12.5 ml versus 690.85 ± 198.41 and 110.06 ± 13.47 ml, respectively, (p < 0.001). Total blood loss was 30 % less in the study group (p < 0.001). Six mothers had PPH in the control group, while none in the study group. The difference between the pre-operative and post-operative haemoglobin levels was significantly less in the study group than the control group, 0.26 ± 0.22 versus 0.99 ± 0.48 g% (p < 0.001).There was no significant difference with respect to other haematological parameters. There was no added adverse effect or need for NICU admission in the study group., Conclusion: Pre-operative IV tranexamic acid significantly reduced blood loss during elective CS without any significant adverse effects., Competing Interests: The authors declare that they have no conflicts of interest. Research involving human participants and/or animals No animals were involved in this study. Only human participants were included in both case and control. Ethical approval All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed Consent Written informed consent has been taken from all patients participating in the trial.

Non-governmental organisations (NGOs) are widely believed to raise their flag in humanitarian hotspots with a strong media presence in order to attract higher private donations. We assess this hypothesis by comparing the changes in donations between US-based NGOs with and without aid operations in the four countries most affected by the tsunami in the Indian Ocean in 2004. Simple before-after comparisons tend to support the hypothesis that 'flying the flag' helps attract higher private donations. However, performing a difference-in-difference-in-differences (DDD) approach, we find only weak indications that private donors systematically and strongly preferred NGOs with operations in the region. Extended specifications of the baseline regressions reveal that our major findings are robust. NGO heterogeneity matters in some respects, but the DDD results hold when accounting for proxies of the NGOs' reputation and experience., (© 2016 The Author(s). Disasters © Overseas Development Institute, 2016.)

Background: Hypolipidemic activity of gugulipid has been widely described in traditional literature., Objective: This study was done to evaluate hypolipidemic activity of guggul and atorvaststin monotherapy in comparison to their combination in rabbits., Materials and Methods: Male New Zealand White rabbits (body weight 1.3-1.8 kg and age 8-10 weeks) were made hyperlipidemic by feeding cholesterol (0.5 g/kg) for three weeks and randomly divided into a control and three treatment groups receiving: atorvastatin (3.7 mg/kg), guggul (3.5 mg/kg) and their combination (same dose) for the next three weeks. Body weight measurements, estimation of serum lipid profile were done at the beginning, after three and six weeks, respectively. Histopathological examination of liver, heart and aorta was done after six weeks. Statistical analysis was done with SPSS version 16.0 using one-way and repeated measures analysis of variance (ANOVA) followed by post-hoc multiple comparison test with two tailed P value < 0.05 as significant., Results: All treated groups had significant reduction in cholesterol, triglyceride, low-density lipoprotein (LDL) and very low-density lipoprotein (VLDL) in comparison to pre-treatment values and control group, and had significant increase in high-density lipoprotein (HDL) in comparison to pre-treatment values., Conclusion: Combination of atorvastatin and guggul was comparable to their monotherapies in improving lipid profile.

Introduction: To investigate if decreased exercise capacity is an independent risk factor for major adverse cardiovascular events (MACE) in diabetics and nondiabetics., Material and Methods: The association of decreased exercise capacity (EC) during a treadmill exercise sestamibi stress test with MACE was investigated in 490 nondiabetics and 404 diabetics. Mean follow-up was 53 months., Results: Nondiabetics with a predicted EC < 85% had a higher prevalence of myocardial ischemia (34% vs. 19%, p = 0.0002), 2- or 3-vessel obstructive coronary artery disease (CAD) (31% vs. 13%, p = 0.016), myocardial infarction (MI) (17% vs. 7%, p = 0.0005), stroke (8% vs. 2%, p = 0.002), death (11% vs. 3%, p = 0.0002), and MI or stroke or death at follow-up (32% vs. 11%, p < 0.001) compared to nondiabetics with a predicted EC ≥ 85%. Diabetics with a predicted EC < 85% had a higher prevalence of myocardial ischemia (48% vs. 32%, p = 0.0009), 2- or 3-vessel obstructive CAD (54% vs. 28%, p = 0.001), MI (32% vs. 14%, p < 0.001), stroke (22% vs. 6%, p < 0.001), death (17% vs. 9%, p = 0.031), and MI or stroke or death at follow-up (65% vs. 27%, p < 0.001). Stepwise Cox regression analysis showed decreased EC was an independent and significant risk factor for MACE among nondiabetics (hazard ratio 3.3, p < 0.0001) and diabetics (hazard ratio 2.7, p < 0.0001)., Conclusions: Diabetics and nondiabetics with decreased EC were at increased risk for MACE with nondiabetics and decreased EC at similar risk as diabetics with normal EC.

Objectives: Chronic urticaria (CU) is characterized by frequent appearance of wheals for ≥ 6 weeks. This study was undertaken to compare effectiveness and safety of olopatadine, a newer antihistamine with additional anti-inflammatory properties, in treating CU in comparison to the established second-generation antihistamine levocetirizine., Methods: A single center, assessor-blind, randomized (1:1), active-controlled, parallel group, Phase IV trial (CTRI/2011/08/001965) was conducted with 120 adult CU patients of either sex. Subjects received either olopatadine (5 mg b.i.d.) or levocetirizine (5 mg/day) for 9 weeks, continuously for first 4 weeks and then on demand basis for last 5 weeks. Primary outcome measures were urticaria activity score (UAS) and urticaria total severity score (TSS). Routine hematological and biochemical tests and treatment-emergent adverse events were monitored for safety., Results: Data from 54 subjects on olopatadine and 51 on levocetirizine were analyzed for effectiveness. UAS and TSS values declined significantly with both drugs over the treatment period but the reduction was greater with olopatadine. Adverse event profiles were comparable with sedation being the commonest complaint., Conclusions: Olopatadine is a safe and more effective alternative to levocetirizine in the treatment of CU.

Introduction: Fluoxetine is a commonly prescribed drug which is used in the psychiatric practice and adenomyosis is a common medical problem in women of the reproductive age group., Objective: To explore the role of fluoxetine in the causation of adenomyosis., Methods: Female Wistar rats (n=18) were divided into three groups (group I (the control), group II and group III) and they were treated with normal saline and oral fluoxetine (4mg/kg and 8 mg/kg) respectively for 100 days. Periodic serum prolactin measurements and histopathological examinations of the uterine horns of all the rats were done at the end. Comparison of the mean serum prolactin levels between the patients (n=15) who were diagnosed with adenomyosis, the healthy age sex matched controls and the female patients (n=20) who received fluoxetine for more than 3 months, before and after the fluoxetine administration, was done separately. Appropriate (paired or unpaired) t tests were used for the data analysis., Results: Out of the 12 test group rats, 10 rats showed the features of adenomyosis histopathologically, along with significantly (p < 0.05) raised serum prolactin levels. The mean serum prolactin levels of the patients of adenomyosis in comparison to those of the controls and of the patients who were treated with fluoxetine (before and after the fluoxetine administration), were significantly high (p=0.001 in both the cases)., Conclusion: Fluoxetine may have some role in the causation of adenomyosis; although for a stronger evidence, the follow-up of the patients who are treated with fluoxetine on a long term basis should be ideal.

Objective: Evaluation of antidiabetic potential of the hydroalcoholic extract of Withania coagulans Dunal dried fruit (WCDF) alone and in combination with glipizide, in streptozotocin-induced diabetes, and evaluation of possible antihyperlipidemic activity of the same extract in high-cholesterol diet-induced hyperlipidemia, in albino rats., Materials and Methods: Experimental diabetes was induced in 30 albino rats with intraperitoneal injection of streptozotocin (55 mg/kg). The rats were divided into five groups receiving the following treatments orally for 4 weeks: Vehicle, glipizide (2.5 mg/kg), WCDF extract (1000 mg/kg), WCDF extract (1000 mg/kg) plus glipizide (1 mg/kg) and WCDF extract (1000 mg/kg) plus glipizide (2.5 mg/kg). Fasting and postprandial blood glucose levels were measured every week for 4 weeks. Endocrine pancreas histopathology was done at the end. In a separate set of experiment, five groups of six albino rats each, received orally for 4 weeks, vehicle, cholesterol (25 mg/kg/day), cholesterol (25 mg/kg/day) plus atorvastatin (7.2 mg/kg/day), cholesterol (25 mg/kg/day) plus WCDF extract (1000 mg/kg/day) and no treatment, respectively. Estimation of serum lipid profile and liver histopathology was done at the end of 4 weeks., Statistical Analysis: Between-group and within-group comparisons were respectively done by analysis of variance (ANOVA) and repeated measures ANOVA, followed by post hoc Tukey's test, with a significance level of P < 0.05., Results and Conclusions: The 4-week treatment with WCDF extract significantly reversed hyperglycemia in streptozotocin-induced diabetes that was comparable to glipizide. When combined with glipizide (2.5 mg/kg), WCDF extract produced a synergistic antihyperglycemic effect as well as improvement in pancreatic histopathology. Moreover, hydroalcoholic extract of WCDF was effective and comparable to atorvastatin in controlling the high-cholesterol diet-induced hyperlipidemia in rats.

Backgrounds: This study was conducted to establish olanzapine-induced hepatopathy in Wistar albino rats as a newer model to screen putative hepatoprotective agents namely silymarin., Materials and Methods: Albino rats were divided into three groups, namely vehicle control group (CG), olanzapine-treated group (OZ), and olanzapine plus silymarin (OZS) treated groups. Both the OZ and OZS groups were treated with the same dose of intraperitoneal olanzapine for 6 weeks and group OZS additionally received oral silymarin. Baseline and terminal hepatic enzymes (SGOT, SGPT, and ALP) were measured in all three groups., Results: Histopathological examination of livers of both OZ and OZS groups showed degenerative changes, whereas those of control group showed normal architecture. Liver enzyme levels showed statistically significant rise in comparison to the control group as well as the respective base line values in both the test groups, but the differences in the rise of liver enzymes between the two test groups were not statistically significant., Conclusion: Olanzapine-induced hepatopathy in rats can be used as a model for screening putative hepatoprotective agents and in our setting silymarin has failed to provide any hepatoprotection.

Torsades de pointes (TdP) or polymorphic ventricular tachycardia owing to drug-induced QT prolongation is a common cause of withdrawal of marketed drugs and has caused increasing concern in the recent past. Carbimazole, the common antithyroid drug, is not a very well-known offender to cause QT prolongation and TdP. Only a few cases of carbimazole-induced TdP have been reported so far. We report a 53-year-old woman who was on tab. carbimazole (10 mg) twice daily for one month and who presented with respiratory distress, palpitation and syncope attack. Her surface electrocardiogram (ECG) was showing the evidence of TdP and subsequently hypokalemia was also detected. She received conservative management including potassium supplementation. However, QT prolongation persisted even after normalization of serum potassium level. Carbimazole was withdrawn and the patient was discharged as she remained stable and symptom free. This study highlights a possible association between carbimazole and TdP.