Cold Clinical Trial
Official title:
National Clinical Trial,Phase III, Multicenter, Randomized, Prospective, Double-blind, Parallel, Placebo-controlled, to Evaluate the Efficacy, Safety and Superiority of Decongex Gripe in the Treatment of Symptoms Associated With Common Cold
National clinical trial, phase III, multicenter, randomized, prospective, double-blind, parallel, placebo-controlled, which one hundred and fifty (150) subjects of both sexes aged equal or more than 18 years will be randomly allocated to one the drug group or placebo group.
The investigational product is a combination of desloratadine, phenylephrine hydrochloride
and ibuprofen.
The desloratadine is a antihistamine and selectively block the activity of histamine
receptor-1 (H1) resulting in a non sedative and prolong antiallergic effect.
The phenylephrine is a potent stimulator of the postsynaptic α receptor with minimal effect
on β receptors in the heart.
The ibuprofen's mechanism is not fully known. It is a non selective inhibitor of
cyclooxygenase, an enzyme that is involved in prostaglandin synthesis by the route from
arachidonic acid. It is believed that the pharmacological effects are due to inhibition of
cyclooxygenase-2 (COX-2), which reduces prostaglandin synthesis involved in the mediation of
inflammation, pain, fever and swelling.
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