DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20185123

Efficacy and safety of a fixed dose combination of paracetamol, chlorpheniramine maleate and phenylephrine in treatment of common cold: a phase IV, open-labelled, multi-centric study

Mayuresh D. Kiran, Monali P. Vakharia, Lalit J. Pawaskar, Shaheen N. Sheikh

Abstract


Background: Acute coryza or common cold affects the upper airways, sometimes in association with low-grade fever and systemic symptoms, and usually presents with at least two of the following symptoms: cough, dysphonia, throat discomfort, sore throat, nasal congestion, rhinorrhoea, sneezing, headaches, myalgia and fever. A triple combination of analgesics, decongestants and antihistamines provides better relief for multiple symptoms in common cold and allergic rhinitis according to various studies. A combination of Paracetamol as an analgesic, anti-inflammatory and antipyretic, Chlorpheniramine maleate, an anti-histaminic and Phenylephrine as a nasal decongestant is popular in the treatment of common cold. Hence the present study was planned to evaluate efficacy and safety of this combination in treatment of common cold.

Methods: This was a phase IV, open-labelled, multicentric study in 159 patients. Efficacy assessment was done by analyzing the reduction in mean TSS at each follow-up visit and safety assessment was done by analyzing the adverse events during the study.

Results: There was reduction in mean TSS from 6.62 (day 1) to 3.56 (day 3) and 0.69 (day 5). Most of the patients had >50% reduction in total symptom score at visit 3 and 58.49% patients had complete relief from the symptoms at the end of study. Out of 159 patients, 26 i.e. 16.36% experienced adverse events. Sedation and drowsiness (6.29%) were the most common adverse event seen in patients.

Conclusions: A fixed dose combination of Chlorpheniramine maleate, Paracetamol, and Phenylephrine is safe and effective in the treatment of common cold.


Keywords


Chlorpheniramine maleate, Common cold, Paracetamol, Phenylephrine

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References


Mossad SB. Fortnightly review: treatment of the common cold. BMJ: British Medical Journal. 1998 Jul 4;317(7150):33.

Van Schoor J. Colds, flu and coughing: a review of over-the-counter cold and flu medicines. South African Family Practice. 2013;55(4):334-9.

Kirkpatrick GL. The common cold. Primary Care: Clinics in Office Practice. 1996 Dec 1;23(4):657-75.

Health in India and the over the counter opportunity. Neilsen newswire. 2013. Available at: https://www.nielsen.com/qa/en/insights/news/2013/health-in-india-and-the-over-the-counter-opportunity.html as accessed on 20/11/2018 at 10:13 hrs.

Jackson GG, Dowling HF, Spiesman IG, Boand AV. Transmission of the common cold to volunteers under controlled conditions. I. The common cold as a clinical entity. AMA Arch Intern Med. 1958;101:267-78.

Picon PD, Costa MB, da Veiga Picon R, Fendt LC, Suksteris ML, Saccilotto IC, et al. Symptomatic treatment of the common cold with a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine: a randomized, placebo-controlled trial. BMC infectious diseases. 2013 Dec;13(1):556.

Health guidelines. The common cold. 2013;10-17. Available at: https://dphhs.mt.gov/Portals/85/dsd/documents/DDP/MedicalDirector/ CommonCold101713.pdf as accessed on 20/11/2018 at 12:08 hrs.

De Sutter AI, van Driel ML, Kumar AA, Lesslar O, Skrt A. Oral antihistamineā€decongestantā€analgesic combinations for the common cold. Cochrane Database of Systematic Reviews. 2012(2).

Eccles R, Fietze I, Rose UB. Rationale for Treatment of Common Cold and Flu with MultiIngredient Combination Products for Multi-Symptom Relief in Adults. Open J Resp Dise. 2014;4:73-82.

Kiran M, Pawaskar L, Yadav P. Efficacy and safety of a combination of paracetamol, levocetrizine and phenylephrine in the symptomatic treatment of common cold and allergic rhinitis. Int J Curr Res Med Scien. 2017;3(1):53-9.

Kiran M, Pawaskar L. Safety and Efficacy of a combination of Paracetamol, Phenylephrine and Fexofenadine in adult patients of Common Cold and Allergic Rhinitis: Phase IV Study. World J Pharmaceut Resea. 2017;6(4):1624-34.

Kiran M, Pawaskar L, Yadav P. Efficacy and Safety of a combination of Paracetamol, Chlorpheniramine maleate and Phenylephrine in the symptomatic treatment of Common Cold: Phase IV Clinical study. The Indian Practitioner. 2017;70(2).