Homeopathic Cold Remedy for Children Study

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial of a Homeopathic Cold Remedy for Children

Conditions
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Upper Respiratory Tract Infections

Intervention / Treatment
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* Drug: Hyland's Cold 'n Cough 4 kids
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Homeopathic cold remedy<br>5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms | Drug: Hyland's Cold 'n Cough 4 kids<br>* 5 ml PO q4h prn cold symptoms<br>|
| Placebo Comparator: placebo<br>5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms | Drug: placebo<br>* liquid made to look like the active homeopathic remedy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Severity of Cold Symptoms | Parents measured change in runny nose, cough, nasal congestion and sneezing severity one hour after administering a dose of study medication up to the first 10 doses of study medication. Change in symptom rated from 0 to 6, with 0 indicative of the symptom being much worse and 6 indicative of the symptom being much improved. The unit of analysis for each outcome was doses of medication. Each participant could contribute data on 0 - 10 doses. | Parents assessed change in symptom 1 hour after a dose of study medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Non-specific Symptoms | Parents measured change in severity of irritability, lethargy, fussiness, and appetite one hour after administering a dose of study medication up to the first 10 doses of study medication. Change in symptom rated from 0 to 6, with 0 indicative of the symptom being much worse and 6 indicative of the symptom being much improved. The unit of analysis for each outcome was doses of medication. Each participant could contribute data on 0 - 10 doses. | Parents assessed change in symptom 1 hour after dose of study medication | 
| Functional Status | Change in functional status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated 5 activities (vigorous activity, activities that require concentration, activities with family or friends, appetite and sleep) daily for 3 days in their child and again at the 7-10 day follow-up. Functional status scores range from 0 to 15, with higher scores indicative of better functional status. | 10 days | 
| Health Status | Change in health status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated health status on 1-10 scale with 1 indicating perfect health and 10 indicating very sick. Health status rated on first 3 days of study and again at the 7-10 day follow-up | 10 days | 
| Overall Symptom Severity | Change in cold symptoms of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents assessed severity of runny nose, cough, sneeze and congestion in their child using a 0-3 scale for each symptom, 0=none to 3= severe. Cold score is sum of scores for each symptom. Parents assessed cold score twice daily on study days 1-3 and at the 7-10 day follow-up | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, upper respiratory tract infections, homeopathy