Conditions: Infection
Keywords: Cough assessment in upper respiratory infection guaifenesin honey
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 265
Healthy volunteers: no

Brief summary:
The objectives of this study are: a) to assess the feasibility and sensitivity of manually count cough bouts over a 4-hour period; b) to assess the effects of buckwheat honey and guaifenesin 400 mg immediate release tablets compared to placebo on the frequency and severity of acute cough due to upper respiratory tract infection and c) to evaluate the correlation between cough bout frequency and subjective assessments of cough severity. The hypotheses to be tested is that 10 ml of buckwheat honey and 400 mg of immediate release guaifenesin will significantly reduce the frequency and severity of cough compared to placebo over a 4-hour evaluation period.

Detailed description:

Arms:
arm 1: Placebo arm 2: Guaifenesin arm 3: Buckwheat Honey

Interventions: intervention 1: Placebo intervention 2: Guaifenesin intervention 3: Buckwheat Honey
Intervention descriptions: intervention 1: One placebo tablet administered orally as a single dose intervention 2: One 400 mg immediate release tablet administered orally as a single dose intervention 3: 10 mL administered orally as a single dose

Protocol document: