Safety & Efficacy of a Fixed Dose Combination of Paracetamol (125 mg), Phenylephrine (2.5 mg) and Chlorpheniramine Maleate (1mg) [Flucold Drops] in the Treatment of Common Cold and Flu Syndrome in Children : Postmarketing Surveillance Study

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dc.contributor.authorKumar, Pankajen_US
dc.contributor.authorMenezes, Rashmien_US
dc.contributor.authorPinto, Vinayen_US
dc.contributor.authorArora, Deepaken_US
dc.contributor.authorJayseela, Karunrajen_US
dc.contributor.authorKumar, Sumiten_US
dc.contributor.authorRajdeo, Dipeshhen_US
dc.contributor.authorS, Harishen_US
dc.contributor.authorZ, Vindaen_US
dc.contributor.authorD, Tapasen_US
dc.date.accessioned2023-06-17T08:33:54Z
dc.date.available2023-06-17T08:33:54Z
dc.date.issued2022-05
dc.description.abstractBackground :The common cold and flu syndrome primarily affects the upper respiratory tract, along with a low fever and some systemic symptoms such as sore throat, cough, nasal decongestion, headache, and so on. Several clinical studies have shown that combining analgesics, antihistaminics, and decongestants provides better symptom relief in the common cold. The current post-marketing surveillance study was designed to look into the safety and efficacy of commercially available Flucold Drops in the Indian population. Methodology :A current prospective, single arm, multicenter, post-marketing clinical study included 224 subjects, 220 of whom completed the study. All patients were given Flucold Drops for three days and then monitored for the next six days. During the study, the incidence of adverse events (AE) and serious adverse events (SAE) was assessed. The efficacy of the Flucold Drops was evaluated using VAS score changes from the beginning to the end of the treatment. The product’s safety was also evaluated using blood biomarkers such as haemoglobin, platelet count, SGOT, SGPT, and creatinine level. Results : Results show the reduction in symptomatic score of common cold and flu syndrome observed after 2rd follow-up visit (0.202+0.325 to 0.139+0.231). During the study, no intervention-related adverse events were observed. Furthermore, no Serious Adverse Events (SAE) were observed in the study or follow-up period. The study found no changes in the levels of blood biomarkers (haemoglobin, platelets, SGOT, SGPT, and creatinine). Conclusions : Flucold Drops are safe and effective in the treatment of common cold and flu syndrome in Children and infants.en_US
dc.identifier.affiliationsWallace Pharmaceutical Pvt Ltden_US
dc.identifier.affiliationsICBio Clinical Research Pvt Ltd, *Crossponding Authoen_US
dc.identifier.citationKumar Pankaj, Menezes Rashmi, Pinto Vinay, Arora Deepak, Jayseela Karunraj, Kumar Sumit, Rajdeo Dipeshh, S Harish, Z Vinda, D Tapas. Safety & Efficacy of a Fixed Dose Combination of Paracetamol (125 mg), Phenylephrine (2.5 mg) and Chlorpheniramine Maleate (1mg) [Flucold Drops] in the Treatment of Common Cold and Flu Syndrome in Children : Postmarketing Surveillance Study. Journal of The Indian Medical Association. 2022 May; 120(5): 75-79en_US
dc.identifier.issn0019-5847
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/216544
dc.languageenen_US
dc.publisherIndian Medical Associationen_US
dc.relation.issuenumber5en_US
dc.relation.volume120en_US
dc.source.urihttps://www.onlinejima.com/read_journals.php?article=951en_US
dc.subjectFlucold Drops is a fixed dose combination of paracetamol (125 mg)en_US
dc.subjectphenylephrine (2.5 mg) and chlorpheniramine maleate (1mg)en_US
dc.subjectSGOTen_US
dc.subjectSGPTen_US
dc.subjectFlu syndromeen_US
dc.subjectCongestionen_US
dc.subjectHaemoglobinen_US
dc.titleSafety & Efficacy of a Fixed Dose Combination of Paracetamol (125 mg), Phenylephrine (2.5 mg) and Chlorpheniramine Maleate (1mg) [Flucold Drops] in the Treatment of Common Cold and Flu Syndrome in Children : Postmarketing Surveillance Studyen_US
dc.typeJournal Articleen_US
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