N/A
Completed N=263
Homeopathic Cold Remedy for Children Study
Upper Respiratory Tract Infections
Source: ClinicalTrials.gov NCT01257503 ↗
Enrolled (actual)
263
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcomePrimary: Change in Severity of Cold Symptoms — 3.7; 3.7; 3.9; 3.9 units on a scale — p=.86
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Severity of Cold Symptoms |
3.7; 3.7; 3.9; 3.9; 3.8; 3.8 | .86 |
| SECONDARY Change in Non-specific Symptoms |
3.6; 3.5; 3.6; 3.6; 3.6; 3.5 | .61 |
| SECONDARY Functional Status |
11.0; 10.4; 11.7; 11.8; 12.7; 12.5 | .16 |
| SECONDARY Health Status |
4.4; 4.9; 3.8; 4.1; 3.2; 3.4 | .10 |
| SECONDARY Overall Symptom Severity |
4.6; 5.5; 4.2; 5.0; 3.7; 4.0 | .02 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01257503). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.