Conditions: Common Cold
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 53
Healthy volunteers: no

Brief summary:
This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group, single-dose study will assess the efficacy and tolerability of the active tablets versus placebo in participants suffering from cold and influenza. Eligible participants will be randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a four-hour (hr) treatment phase. Each participant will be administered only once during each study period. Participants will use a questionnaire to record the symptom severity scores as described, as well as time.

Detailed description:

Arms:
arm 1: Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg). arm 2: Matching placebo tablet

Interventions: intervention 1: Test tablet intervention 2: Placebo
Intervention descriptions: intervention 1: The active tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity intervention 2: The placebo tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity

Protocol document: