Study on safety and efficacy of paracetamol, phenylephrine, and chlorpheniramine in kids with cold.
Journal name: World Journal of Pharmaceutical Research
Original article title: Post-marketing surveillance study to evaluate the efficacy and safety for the combination of paracetamol, phenylephrine and chlorpheniramine maleate in paediatric patients of common cold
The WJPR includes peer-reviewed publications such as scientific research papers, reports, review articles, company news, thesis reports and case studies in areas of Biology, Pharmaceutical industries and Chemical technology while incorporating ancient fields of knowledge such combining Ayurveda with scientific data.
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Mayuresh Kiran, Lalit Pawaskar, Pramita Waghambare and Shaheen Sheikh
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Post-marketing surveillance study to evaluate the efficacy and safety for the combination of paracetamol, phenylephrine and chlorpheniramine maleate in paediatric patients of common cold
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr20218-21002
Copyright (license): WJPR: All rights reserved
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Summary of article contents:
Introduction
The common cold, a prevalent self-limiting viral respiratory illness, significantly impacts daily life and productivity. It is characterized by symptoms such as fever, cough, nasal congestion, and sore throat, prompting patients, particularly children, to seek symptomatic relief. The pharmacological approach comprises combinations of medications targeting various symptoms, as no antiviral treatments are currently available. This post-marketing surveillance study aimed to evaluate the efficacy and safety of a fixed-dose combination of Paracetamol, Phenylephrine, Chlorpheniramine Maleate, Sodium Citrate, and Menthol for treating the common cold in pediatric patients aged 2 to 12 years.
Efficacy of the Combination Therapy
The study enrolled 200 patients, of which 182 completed the treatment over five days. The efficacy was assessed using a Total Symptom Score (TSS) to evaluate symptom severity. Initial findings revealed a mean TSS reduction from 5.703 at baseline to 3.335 by day 3, and further to 0.802 by day 5. These results indicate a significant percentage reduction in mean TSS—41.52% by day 3 and 85.93% by day 5—demonstrating the combination therapy's effectiveness in alleviating cold symptoms.
Safety Profile of the Investigational Product
Safety assessments during the study involved monitoring adverse events associated with the combination product. Out of the entire patient population, only six non-serious adverse drug reactions were reported, which included symptoms like drowsiness and nausea. Importantly, these reactions were anticipated and not considered severe. This indicates a favorable safety profile for the fixed-dose combination, bolstering the findings that the product is suitable for use among children experiencing common cold symptoms.
Methodology and Design
This multicentric study employed an open-label design across twelve clinical sites, focusing on pediatric patients. Patients aged 2 to 12 years, weighing between 12 to 39.9 kg, were recruited based on stringent inclusion and exclusion criteria to ensure participant safety and study integrity. Following informed consent, patients were provided with the investigational product and monitored over five days, with caregivers keeping a diary of daily symptoms to evaluate drug efficacy and safety systematically.
Conclusion
The study concluded that the fixed-dose combination of Paracetamol, Phenylephrine, Chlorpheniramine Maleate, Sodium Citrate, and Menthol per 5 ml is both effective and safe for symptomatic treatment of the common cold in Indian pediatric patients. The significant reduction in symptoms alongside the mild nature of reported adverse events underlines the therapeutic benefits of this combination in relieving cold-related discomfort, thereby supporting its use in clinical practice.
FAQ section (important questions/answers):
What is the purpose of the study conducted by Pawaskar et al.?
The study aims to evaluate the efficacy and safety of a combination treatment involving Paracetamol, Phenylephrine, Chlorpheniramine Maleate, Sodium Citrate, and Menthol for pediatric patients suffering from the common cold.
What symptoms are associated with the common cold evaluated in this study?
Symptoms include fever, nasal congestion, cough, rhinorrhoea, sore throat, body ache, and malaise, which significantly affect patients' daily productivity and well-being.
What were the key findings regarding symptom reduction in the study?
The mean total symptom score (TSS) decreased from 5.703 at baseline to 0.802 by day 5, indicating a significant symptomatic relief, with reductions of 41.52% and 85.93% by days 3 and 5 respectively.
How many patients experienced adverse reactions during the study?
Only 6 non-serious adverse drug reactions were reported during the study, including nausea and drowsiness, indicating a favorable safety profile for the investigational product.
What is the target age group for this combination treatment?
The study focuses on pediatric patients aged 2 to 12 years old, providing relevant findings for symptomatic treatment in this specific age demographic.
What are the components of the investigational drug tested?
The investigational product is a fixed-dose combination of Paracetamol (250 mg), Phenylephrine (2 mg), Chlorpheniramine Maleate (2 mg), Sodium Citrate (60 mg), and Menthol (1 mg) per 5 ml.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Study on safety and efficacy of paracetamol, phenylephrine, and chlorpheniramine in kids with cold.”. This list explains important keywords that occur in this article and links it to the glossary for a better understanding of that concept in the context of Ayurveda and other topics.
1) Study (Studying):
Study refers to the systematic investigation conducted to evaluate the efficacy and safety of a drug combination for treating common cold in pediatric patients. It aimed to gather data on symptom relief and the occurrence of adverse effects associated with the investigational product among participants over a specified duration.
2) Visit:
Visits refer to the scheduled clinical assessments where patients were evaluated for symptom relief and potential adverse events. These visits are integral to gathering structured data and ensuring ongoing evaluation of patient health, aiding in comprehensive analysis and documentation of treatment outcomes.
3) Drug:
Drugs encompass any pharmacological compounds involved in the study, including the investigational combination for common cold treatment. This term emphasizes the role of medication in managing symptoms, the necessity for careful evaluation of efficacy, and monitoring of safety outcomes during the trial.
4) Indian:
Indian signifies the geographical and cultural context of the study. It indicates that the research was conducted in India, involving participants who are Indian by nationality. This aspect is crucial for understanding the applicability of study findings in similar demographics and health conditions prevalent in India.
5) Post:
Post relates to the timeframe after the marketing of the investigational product, indicating that this surveillance study was conducted to gather evidence on the drug's performance in a real-world setting. It implies a focus on gathering long-term safety and effectiveness data following approval for public usage.
6) Nature:
Nature describes the inherent characteristics and self-limiting aspect of the common cold as a viral illness. Understanding its nature emphasizes that while symptomatic treatments are critical, the condition typically resolves on its own, influencing how treatment protocols and patient expectations are managed.
7) Maharashtra (Maharastra, Maha-rashtra):
Maharashtra is a significant state in India where some of the clinical trial sites were located. The inclusion of Maharashtra highlights the geographic diversity of the study participants, which is essential for assessing the wider applicability of the findings across various population segments within India.
8) Disease:
Disease refers to the common cold, which is the primary focus of the study. It is characterized as a self-limiting viral upper respiratory infection that affects daily functionalities. Understanding its implications helps frame the necessity for effective symptomatic treatment to alleviate patient discomfort.
9) Drowsiness:
Drowsiness is one of the reported adverse drug reactions during the study. Tracking this side effect is important for evaluating the safety profile of the investigational product, ensuring that any impacts on patient alertness and overall wellbeing are monitored sufficiently throughout the treatment duration.
10) Fever:
Fever is a common symptom associated with the common cold, indicating the body's response to infection. The study assesses the efficacy of the investigational drug in alleviating febrile symptoms, which is crucial for evaluating the overall benefit of the combination treatment for affected patients.
11) Pharmacological:
Pharmacological pertains to the study of drugs and their effects on the body's functions. This term highlights the nature of the investigational product, emphasizing the scientific investigations into drug interactions, efficacy, and safety within the context of treating common cold symptoms.
12) Nausea:
Nausea is another reported adverse event from the study. Monitoring nausea as a side effect is crucial in evaluating the tolerability of the investigational drug among pediatric patients, impacting overall patient compliance and the acceptability of the treatment regimen.
13) Delhi:
Delhi denotes one of the cities involved in the study's clinical trial sites. The inclusion of Delhi participants adds to the diversity of the sample population, reinforcing the broader relevance of the study’s findings across urban populations in India, which may have varying health profiles.
14) India:
India serves as the focal country for the study, representing a diverse population of pediatric patients. The findings are particularly relevant within this context, as they can guide local clinical practices and healthcare policies related to common cold management in Indian children.
15) Table:
Table refers to the organized presentation of data, likely summarizing findings or adverse events during the study. Tables are essential for concise display of complex information, allowing for quick reference and analysis of results by stakeholders reviewing the study's impact and findings.
16) Blood:
Blood pertains to the physiological monitoring relevant to understanding the impacts of pharmacological treatments. Although not specifically mentioned in adverse effects, blood pressure monitoring related to medications like Phenylephrine illustrates the need for comprehensive safety assessments to ensure patient wellbeing.
17) Discussion:
Discussion represents the section where the implications of the study's findings are analyzed. It includes interpretations of results, comparisons to existing literature, and contextualizes the impact of treatment efficacy, contributing to the broader medical and clinical knowledge regarding common cold therapy.
18) Resolving:
Resolving refers to the natural process by which the common cold symptoms subside over time. Understanding this aspect informs how study results are interpreted, acknowledging that while treatments may aid in symptom relief, self-resolution is an inherent characteristic of the condition.
19) Suffering:
Suffering reflects the patients' experience of discomfort and symptoms associated with the common cold. Recognizing the impact of suffering underscores the significance of effective treatment options that can alleviate symptoms and improve overall quality of life for affected individuals.
20) Mahendra (Mahemdra, Maha-indra):
Mahendra refers to a contributor or investigator involved in the study. Recognizing individual contributions helps to credit those who facilitated the research process, establishes leadership within the study, and provides insight into the expertise engaged in conducting the clinical trial.
21) Shailaja (Sailaja, Shaila-ja):
Shailaja is another investigator contributing to the study. This highlights the collaborative effort of professionals working together to ensure comprehensive evaluation, driving the research forward, and ensuring adherence to ethical and methodological standards throughout the study phases.
22) Activity:
Activity indicates the set of actions taken within the context of the post-marketing surveillance study. This encompasses all operational aspects—from patient recruitment and treatment administration to monitoring and data collection—essential for evaluating the investigational product’s performance in real-world scenarios.
23) Punjab:
Punjab identifies another geographic region in India involved in the study. Including participants from Punjab enriches the data by representing varying demographic factors, enhancing the study's outcome reliability, and ensuring the findings are applicable to a broader Indian population.
24) Sharman (Sarma, Sharma, Sarman):
Sharma represents a contributor to the study, potentially being an investigator or collaborating researcher. Recognizing individual names underlines the collaborative nature of clinical trials, acknowledging the diverse expertise that contributes to the successful conduct and analysis of research.
25) Patra:
Patra refers to an investigator involved in the study. Including names of contributors reinforces the collaborative framework of research efforts, spotlighting specific individuals who contribute specialized knowledge necessary for ensuring effective study execution and evaluation.
26) Gupta:
Gupta is another individual recognized for their role as an investigator in the study. Similar to other names mentioned, this signifies the critical contribution of various professionals who partake in conducting clinical research and ensuring that patient safety and data integrity are upheld.
27) Nanda (Namda):
Nanda is an investigator or contributor within the study. Mentioning names fosters appreciation for the teamwork involved in clinical trials and recognizes the importance of collaboration among healthcare professionals in advancing research that affects patient care.
28) Kumar:
Kumar refers to an investigator's involvement in the study, contributing to data collection and analysis. The mention of staff underscores the multi-disciplinary approach required in conducting clinical trials, emphasizing the diverse expertise leveraged for thorough evaluation of treatment efficacy.
29) Dhule:
Dhule notes an investigator associated with the study, marking their geographical origins and professional contribution. Identifying regional contributors emphasizes the need for varied expertise and knowledge from different locations to provide comprehensive outputs on the research conducted.
30) Patil:
Patil indicates a significant contributor in conducting the study, similar to other mentioned investigators. Recognizing individuals in research highlights the collective effort required to produce reliable data and facilitate successful clinical trials that address specific health issues.
31) Water:
Water signifies a non-pharmacological measure encouraged during the study for alleviating symptoms associated with common cold. Promoting hydration reflects patient care strategies that complement drug therapy, ensuring participants receive holistic support during their recovery process.
32) Doshin (Dosin, Dosi, Doshi):
Doshi refers to another investigator involved in the clinical study. Including the names of contributors emphasizes the collaborative efforts in conducting research, recognizing the importance of teamwork in achieving study objectives and ensuring comprehensive monitoring of patient outcomes.
33) Sign:
Sign signifies a symptom or indicator associated with common cold, highlighting criteria for diagnosing and assessing patient conditions. Understanding these signs is crucial for healthcare providers to develop appropriate treatment strategies that are effective in managing the ailment.
34) Male:
Male indicates one of the genders participating in the study, reinforcing inclusivity and representation in clinical research. This aspect is relevant in ensuring that findings are applicable across both genders, thus providing comprehensive insights into treatment responses regardless of gender differences in health.
35) Life:
Life here pertains to the quality of life affected by symptoms of the common cold. Managing and alleviating these symptoms through effective treatment can significantly enhance the daily functioning and overall wellbeing of the affected individuals, particularly children experiencing discomfort.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Study on safety and efficacy of paracetamol, phenylephrine, and chlorpheniramine in kids with cold.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Cooling effect, Clinical examination, Symptomatic treatment, Inclusion and exclusion criteria, Adverse drug reaction, Efficacy assessment, Safety assessment, Open-label study, Antipyretic, Common cold, Antihistaminic drug, Fixed Dose Combination, Adverse event, Investigational product, Paediatric patients.