Conditions: Upper Respiratory Tract Infection Nasal Congestion Rhinorrhea Sneezing
Keywords: Paracetamol dimethindene maleate phenylephrine hydrochloride cold and flu symptoms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 341
Healthy volunteers: no

Brief summary:
The study is a clinical evaluation of an over the counter (OTC) combination product containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10 mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea, sneezing and other symptoms due to upper respiratory tract infection (URTI).

Detailed description:

Arms:
arm 1: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets arm 2: Paracetamol (500 mg) tablets

Interventions: intervention 1: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets intervention 2: Paracetamol (500 mg) tablets
Intervention descriptions: intervention 1: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets intervention 2: Paracetamol (500 mg) tablets

Protocol document: