A Multicentric, Non-Randomized, Open label, Non-Comparative, Active post marketing surveillance study to evaluate the Safety and Efficacy of Sinarest New Tablet in adults with common cold.

Sinarest New Tablet is a fixed dose combination of Paracetamol 500 mg, Phenylephrine 10mg and Chlorpheniramine Maleate 2mg which is indicated for the symptomatic treatment of common cold . Common cold is the most frequently encountered disease in medical practice. It is the most frequent human illness and is caused by members of several families of viruses. The most likely offenders are the ±100 serotypes of rhinoviruses. Common cold affects the upper airways, sometimes in association with low-grade fever and systemic symptoms, and usually presents with symptoms including cough, dysphonia, throat discomfort, sore throat, nasal congestion, rhinorrhoea, sneezing,headaches, myalgia and fever. Symptoms usually peak at 2 to 3 days and have a mean duration of 7 to 10 days. As per the American Academy of Family Physicians, there are no effective antivirals to cure the common cold but there are few effective measures to prevent it including vaccines so ideally the treatment should focus on symptomatic relief rather than treatment for the same. According to the guidelines of DPHHS and Cochrane Review the combination of analgesics, decongestants and antihistamines can provide symptomatic relief from the multiple symptoms of common cold. Paracetamol belongs to a class of Nonsteroidal Anti-inflammatory Drugs (NSAID) and exhibits good central analgesic and antipyretic action. Chlorpheniramine maleate is a first-generation antihistaminic agent and competitively binds to H1 receptors in the nasal mucosa to prevent the histamine-induced vasoreactive responses exhibiting anti-inflammatory as well as anti-allergic actions. The anti-cholinergic action of Chlorpheniramine Maleate is responsible for the decrease in nasal discharge. Phenylephrine is a selective adrenergic receptor agonist, which is an effective nasal decongestant. Its dominant and direct vasoconstricting effects on capacitance blood vessels of the nasal mucosa decrease blood vessel diameter and lead to nasal decongestion. Combinations with the same proposed ratio of Sinarest New Tablet are available as OTC in developed as well as highly regulated countries like Australia, New Zealand, the US, etc and used by patients for symptomatic relief of common cold. Taking into account, the superiority in efficacy and safety of this fixed-dose combination, we are proposing this Active Post-Marketing Surveillance (PMS) of Sinarest New tablet in India. The rationale behind this Active PMS is to document the efficacy and safety of Sinarest New Tablet for the treatment of common cold in Indian patients.