Conditions: Upper Respiratory Tract Infections
Keywords: children upper respiratory tract infections homeopathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 263
Healthy volunteers: no

Brief summary:
A randomized controlled trial of a commercially available homeopathic cold remedy will be conducted. A total of 400 children, 2-5 years old, diagnosed with an upper respiratory tract infection will be randomized to receive either the homeopathic remedy or placebo. Parents of study children will administer 5 ml of the study medication up to 6 times per day as needed to treat cold symptoms. One hour after giving a dose the parent will rate change in symptoms (for up to the first 10 doses). In addition, parents will rate their child's overall symptom severity and functional status over the first 3 days of the cold. It is postulated that children receiving the active homeopathic remedy will have better symptom relief and that their symptom severity and functional status will improve more rapidly than those receiving placebo.

Detailed description:

Arms:
arm 1: 5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms arm 2: 5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms

Interventions: intervention 1: Hyland's Cold 'n Cough 4 kids intervention 2: placebo
Intervention descriptions: intervention 1: 5 ml PO q4h prn cold symptoms intervention 2: liquid made to look like the active homeopathic remedy

Protocol document: