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This investigational topical mouthwash formulation was developed by **Qazvin University of Medical Sciences** for the treatment of **recurrent aphthous stomatitis (RAS)**. The combination therapy consists of three active components: **ibuprofen**, a nonsteroidal anti-inflammatory drug (NSAID); **diphenhydramine**, an antihistamine with local anesthetic properties; and **aluminum magnesium simethicone (AlMgS)**, an antacid and anti-foaming agent that acts as a mucosal protective coating. The formulation is designed to provide symptomatic relief by reducing pain and inflammation associated with oral ulcers. Ibuprofen functions by inhibiting cyclooxygenase (COX) enzymes to decrease prostaglandin synthesis, while diphenhydramine targets histamine H1 receptors. The therapy was evaluated in a Phase 2 double-blind randomized clinical trial (NCT01293968) to determine if the addition of ibuprofen to a standard diphenhydramine and AlMgS mixture offered superior symptom relief when applied topically three times daily.
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