Homeopathic Cold Remedy for Children Study

University of Washington

Status: Completed

Conditions: Upper Respiratory Tract Infections

Treatments: Drug: Hyland's Cold 'n Cough 4 kids; Drug: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01257503

39489-D

Details and patient eligibility

About

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.

Enrollment: 263 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinical diagnosis of upper respiratory tract infection
• duration of symptoms < 7 days
• Parent who speaks English

Exclusion criteria

• history of asthma
• on any prescribed medication
• prescribed any medication other than acetaminophen or ibuprofen at index visit
• use of homeopathic remedy within 48 hours of index visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

263 participants in 2 patient groups, including a placebo group

Homeopathic cold remedy

Experimental group

Description:

5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms

Treatment:

Drug: Hyland's Cold 'n Cough 4 kids

placebo

Placebo Comparator group

Description:

5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms

Treatment:

Drug: placebo