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Efficacy and Safety of a Combination of Paracetamol, Chlorpheniramine Maleate and Phenylephrine in the Symptomatic Treatment of Common Cold : Phase IV Clinical Study
Introduction and Background: Commoncold is one of the most frequently encountered disease in clinical practice. Though self-limiting, it accounts for major loss of work and school days so symptomatic therapy to treat the symptoms is often employed. A combination of Paracetamol, an antipyeretic/anti-inflammatory, Phenylephrine, a nasal decongestant and Chlorpheniramine maleate, an anti-histaminic is popular in the treatment of common cold. This Phase IV study evaluated the efficacy and safety of a combination of Paracetamol, Phenylephrine and Chlorpheniramine maleate in treatment of common cold. Methodology -Of 216 enrolled, 187 patients completed the study. Efficacy assessment was made by reduction in TSS and four point Likert-type scales. Safety assessment was made by analyzing the adverse events during trial. Results -Reductionin TSS from 6.58 (baseline) to 3.76 (day 3) and 1.78 (day 5). One point reduction in Likert-type symptom scale from Moderate to Mild took just 3 days. Nearly all the patients had >50% reduction in symptom score at all visit and majority of patients had complete relief from the symptom. 31 episodes of adverse events occurred and were of mild intensity. Conclusion - A combination of Paracetamol, Phenylephrine and Chlorpheniramine maleate is safe and effective in the treatment of common cold.
Paracetamol, Phenylephrine, Chlorpheniramine Maleate, Common Cold, Total Symptom Score (TSS), Likert-Type Symptom Severity Scale.
- Mossad SB, Treatment of the common cold, BMJ 1998, 317:33–36.
- Ruth Martin Misener. Commentary on Review: a single dose of nasal decongestant reduces congestion in the short term in adults with the common cold; insufficient evidence exists on the effectiveness of repeated doses. Evidence-Based Nursing 2005; 8:12.
- Madeline Simasek e al., Treatment of the Common Cold, American Family Physician, Volume 75, Number 4, February 15, 2007.
- De Sutter et al., Antihistamines for the common cold, The Cochrane Library 2003, Issue 3.
- Knollmann, Björn C., ed. Goodman & Gilman’s the pharmacological basis of therapeutics. Vol. 12. New York: McGraw-Hill Medical, 2011.
- Mary Fran Peterlin et al. Nonprescription Chlorpheniramine Maleate and Submaximal Exercise Responses. Arch Phys Med Rehabil July 1998; 79: 827-831.
- De Sutter et al., Oral antihistamine-decongestantanalgesic combinations forthe common cold (Review), The Cochrane Library 2012, Issue 2.
- Picon et al., Symptomatic treatment of the common cold witha fixed-dose combination of paracetamol, chlorphenamine and phenylephrine: arandomized, placebo-controlled trial BMC Infectious Diseases 2013, 13:556.
- Julia Fashner et al., Treatment of the Common Coldin Children and Adults American Family Physician, Volume 86, Number 2, July 2012.
- Eccles, R., Fietze, I. and Rose, U.-B. (2014) Rationale for Treatment of Common Cold and Flu with Multi-Ingredient Combination Products for Multi-Symptom Relief in Adults. Open Journal of Respiratory Diseases, 4, 73-82.
- DCGI Letter 4-012012-DC, CDSCO FDC Division dated 13-09-2013.
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