Abstract:

Introduction: The common cold affects children frequently, with 7-10 episodes annually, imposing significant economic and social burdens. Early management to reduce symptom severity and duration is crucial.

Objective: To evaluate the safety and efficacy of a fixed dose combination (FDC) syrup containing paracetamol, phenylephrine, and chlorpheniramine, for treating common cold symptoms in children aged 6- 18 years.

Methods: The study was conducted in India from March 2021 to December 2022, included 200 children aged 6 to <18 years with cold symptoms lasting 6-72 hours. They received paracetamol 250 mg, phenylephrine hydrochloride 5 mg, and chlorpheniramine maleate 2 mg per 5mL syrup for 5 days. For safety evaluation, the incidence of adverse events and the tolerability of study treatment were assessed, while improvement in common cold symptoms and complete resolution were assessed to evaluate the efficacy of the study treatment.

Results: One patient reported mild drowsiness unrelated to the study drugs. Treatment was well-tolerated, with "good to excellent" responses reported by 94% (parents) and 95% (investigators). Symptom severity significantly decreased by day 5 (p<0.001), with total symptom scores reducing from 9.12 to 0.13 (mean diff: 8.99, 95%CI: 7.86-10.12; p<0.001). 92% of patients showed complete symptom resolution by study end, with no symptom worsening.

Conclusion: The FDC of paracetamol, phenylephrine, and chlorpheniramine syrup effectively managed common cold symptoms in children aged 6 years and older, demonstrating good tolerability.

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ABSTRACT

Background: Common cold often accompanied by mild fever and systemic symptoms in children, poses a significant social burden. Scientific evidence suggests that the pathogenesis of colds involves the activation of multiple inflammatory pathways, rendering single-molecule treatment ineffective against the symptoms. This active post-marketing surveillance study evaluated the safety and efficacy of a fixed-dose combination containing paracetamol, phenylephrine hydrochloride, and chlorpheniramine malate in treating common cold in children aged 2 to 5 years.

Methods: In this clinical study, 200 children with common cold symptoms were enrolled. Maxtra^® P oral drops, a fixed-dose combination containing paracetamol (125 mg), phenylephrine hydrochloride (2.5 mg), and chlorpheniramine maleate (1 mg) per ml drops, were administered as 1 ml every 4 to 6 hours for 5 days. Safety was assessed using the global tolerability assessment based on responses from parents and investigators. Efficacy was evaluated based on symptom severity scores categorised as absent, mild, moderate, severe, or very severe.

Results: Complete remission from common cold symptoms was achieved in 82% (164 patients) of 200 patients. Statistically significant reductions (p<0.001) in symptom severity scores were observed for all common cold symptoms from day 1 to day 5. No adverse events were observed. Maxtra^® P oral drops were regarded as good to excellent for treating common cold symptoms by 92.5% of parents and 97.5% of investigators.

Conclusions: The observations of study indicate that Maxtra^® P oral drops are efficacious and well- tolerated for treating common cold in children aged 2 to 5 years.

Abstract

Background: The common cold ranks as the most frequently encountered respiratory illness in pediatric medical practice. Although not considered serious, the common cold is widespread and can be debilitating, leading to school absenteeism, disturbed sleep, redduced food intake, and interference with daily routines. It impacts not only a child’s general well-being but also family life as it may require parents to stay home to care for sick children. The main goals of common cold management are the reduction of symptom duration and severity. Effective treatments for common cold include over-the-counter analgesics, nasal saline irrigation, decongestants, and with or without antihistamines.

Aims: To evaluate the safety and symptomatic efficacy of a fixed dose combination of Paracetamol 125mg, Phenylephrine 5mg, and Chlorpheniramine maleate 1mg per 5 ml (Maxtra®P) syrup in Indian children with common cold.

Method: This active post-marketing surveillance study was carried out from February 2021 to November 2022. A total number of 200 children with common cold were prescribed Maxtra®P syrup for patients of age 6 to 18 years for 5 days. Safety assessment was done by analysing adverse events during the trial and assessment of treatment response. Efficacy assessment was based on a reduction in the severity of symptoms and the number of patients achieving complete remission at the end of the study.

Results: Out of 200 children, 93% achieved complete relief from common cold symptoms on day 5. At the end of the study, symptoms such as sneezing, headache, hoarseness, wheezing, difficulty in breathing, and malaise completely disappeared in all children. A statistically significant reduction (p < 0.0001) in symptom score was observed for all the symptoms from baseline to day 5. Maxtra®P syrup was well-tolerated and the results suggest no new safety concerns. Mild adverse events such as drowsiness and dizziness were reported in two children. Patients and investigators rated Maxtra®P syrup treatment as ‘good’ and ‘excellent’ in providing symptomatic relief in 94% and 96.5% of children respectively, suggesting a positive global response to treatment.

Conclusion: Maxtra®P syrup was found to be well tolerated and efficacious in the symptomatic relief of the common cold in the Indian pediatric population.

Abstract

A group of senior doctors with vast experience in the management of respiratory diseases got together on 25th June 2022 under the leadership of Dr. V. K. Arora, Dr. D. Behera, Dr. Agam Vora, Dr. Parthiv Mehta, Dr. Arindam Kar, Dr. A. Jaychandra, Dr. B. P. Singh, Dr. S. K. Katiyar, Dr. Subhankar Kandi, Dr. J. K. Samaria, Dr. Parvaiz Koul, Dr. Naveed Nazir Shah, Dr. Rukhsana Najeeb, Dr. N. K. Jain, Dr. Sadiq Ahmad, Dr. Mir Faisal, Dr. Rayees Najib and Dr. Bhupesh Dewan under the auspices of the Academy of Advanced Medical Education. It was a very useful discussion, bringing out their personal experiences regarding the use of Aviptadil in Acute respiratory distress syndrome (ARDS) a life-threatening respiratory condition. ARDS is a manifestation of acute injury to the lung, associated with sepsis, pneumonia, severe pulmonary infections, aspiration of gastric contents, major trauma and tuberculosis.

Abstract:

Background: Preterm labor poses a significant challenge within obstetrics, carrying the potential for diverse complications for both maternal and neonatal well-being. Extensive clinical data indicates that atosiban stands as a secure and well-tolerated therapeutic alternative, exhibiting fewer adverse effects on both the mother and fetus compared to other tocolytic treatments. The investigation aimed to assess the feasibility of achieving optimal medical care by employing a solitary atosiban bolus dose. This approach holds the promise of mitigating the necessity for hospitalization, potentially enabling outpatient management of the condition. Aim: The purpose of the study was to assess the efficacy and safety of using a single bolus dose of atosiban to delay premature delivery. Material and Methods: The study included 75 patients experiencing symptoms of preterm labor. These patients were administered a single bolus dose of atosiban (6.5 mg/0.9mL). The study was conducted between August 2019 and July 2023. Results: The study successfully used a single bolus dose of atosiban to delay delivery by up to 48 hours, enabling corticosteroid prophylaxis. The participants' average gestational age was 32.1 weeks. Atosiban effectively delayed delivery in 68% of patients for an average of 13.3 days, with a range of 0-62 days. No adverse effects were reported by either mothers or fetuses during the study period. Conclusion: The study findings suggest that a single bolus dose of atosiban is an effective and safe treatment option for delaying preterm labor. The treatment provides short-term relief for an average of 13 days, with potential benefits over other tocolytics like isoxsuprine, ritodrine, and nifedipine due to fewer side effects. The intravenous bolus dose of atosiban has a quick onset and long-lasting effects, making it convenient for both patients and physicians. The approach is cost-effective and could be repeated after a few days if necessary. Overall, the study demonstrates the potential of using a single bolus dose of atosiban as an outpatient treatment to manage preterm labor effectively, offering benefits in terms of safety, convenience, and cost.

Abstract

Background: The balance of gut microbiota significantly impacts host health. Disruption of the natural gut flora, often caused by infections or the use of broad-spectrum antimicrobial drugs, can lead to dysbiosis, causing gastrointestinal disorders, such as diarrhea. Probiotics show promising outcomes in restoring gut health, but concerns remain about their interaction with antimicrobials and the viability of spores in the intended gut location. To address these uncertainties, the current study was devised to evaluate how well spores-forming bacteria endure and develop in an environment where antimicrobial agents are present.

Materials and Methods: The study investigated the survival and growth of Bacillus coagulans spores under the influence of broad-spectrum antimicrobial agents, Ofloxacin and Ornidazole. To cultivate the spores in the presence of these antimicrobials, a mixture of MRS broth and PNY agar media was used. The number of colonies that developed were measured to assess the extent of spore survival and germination.

Results: In a simulated environment resembling human intestinal pH, Bacillus coagulans spores exhibited viability. Starting with an initial count of 1.38 billion CFU, the spores multiplied to 8.75 billion CFU at 24 hours and further reached to 86.25 billion CFU at 72 hours in the presence of Ofloxacin and Ornidazole. On the other hand, the viable count reached to the level of 88 billion CFU in the absence of antimicrobial agents.

Conclusion: This study offers evidence that Bacillus coagulans spores are able to remain viable and germinate when co-administered with Ofloxacin and Ornidazole.

Abstract

Objective: This prospective multicentric study was designed to confirm the efficacy and safety of atosiban in preterm labor.

Methods: In a study across 14 sites in India, 406 patients with preterm labor symptoms received up to 48 hours of atosiban infusion. Tocolysis efficacy was gauged by the 72-hour undelivered rate, while safety was assessed via maternal-fetal and neonatal adverse events.

Results: In 400 evaluated patients, the gestation period in 89% of patients was prolonged for more than 48 hours and 83.75% of patients continued their pregnancy up to 72 hours. Amongst the tocolyzed patients, 77% of preterm births were prevented for more than 7 days. The mean duration of gestational period prolongation after the tocolysis was 31.28 days with a mean gestational age at delivery of 35.0 ± 3.15 weeks. Singleton and twin pregnancy prolongation rates for 72 hours were 84.95% and 67.86% respectively. Birth weight of more than 2500 grams was in 54.44% of neonates and an APGAR score of more than 7 after 5 minutes was in 91.82% of neonates. Patients receiving atosiban were more likely to have nausea (2.71%), tachycardia (2.46%), and headache (1.97%). No new or unexpected adverse events were reported in this study.

Abstract

Hemorrhoids, a prevalent medical condition impacting millions globally, fre quently necessitate effective yet minimally invasive treatment methods. This review delves into the prospects of utilizing oral catechins and epicatechins, naturally occurring polyphenolic compounds present in diverse dietary sources, as an innova tive avenue for addressing hemorrhoids. These compounds have antioxidant and anti-inflammatory attributes, which may help alleviate hemorrhoid symptoms. An understanding of the anatomy and pathophysiology of hemorrhoids, emphasizing the need for accessible and versatile treatment options. Subsequently, the focus turns to a detailed exploration of catechin and epicatechin, encompassing their chemical com position, natural origins, and mechanism of action. The core of this review presents a comprehensive analysis of the existing literature, including randomized controlled trials that examine the efficacy of oral catechin and epicatechin supplementation in alleviating hemorrhoidal symptoms. To conclude, this article highlights the potential of oral catechin and epicatechin supplementation as a non-invasive and natural approach to managing hemorrhoids. While promising findings have emerged, further research is essential to solidify their role in hemorrhoid treatment. The comprehen sive assessment of existing literature and critical evaluation of these compounds’ mechanism of action provides valuable insights into their viability as a treatment modality for this common and often distressing medical concern.