Homeopathic Cold Medicine for Children

Study Overview
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Brief Summary
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The purpose of this study is to determine if a commercially available homeopathic cold remedy for children is effective in providing relief from cold symptoms in children 2-5 years old. It is postulated that children will have relief of symptoms after receiving a dose of the cold remedy

Official Title
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Homeopathic Cold Medicine for Children

Conditions
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Upper Respiratory Tract Infection

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 24-59 months old Cold/cough symptoms of <7 days duration Diagnosed with upper respiratory tract infection by physician or nurse practitioner Parent who speaks and reads English Exclusion Criteria: Use of chronic medication other than multivitamins History of asthma Medication other than acetaminophen or ibuprofen Use of homeopathic remedy within preceding 30 days Only 1 participant per family

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 59 Months

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: homeopathic cold remedy<br> | Drug: Hyland's Cold 'n Cough 4 Kids<br>* Liquid homeopathic cold remedy, 5 ml by mouth every 4 hours as needed for relief of cold symptoms for up to 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy. | For each dose of study medication, parents indicated which of the symptoms were present (runny nose, cough, nasal congestion, sneezing). Parents rated change in each symptom present one hour after a dose of study medication for up to 6 doses in study logs. Responses were dichotomized as at least some improvement or better (improvement) vs. no improvement or worse. The outcome measure is number of times that improvement in a specific symptom was noted after a dose of the homeopathic remedy. Completed study logs were received from 37 of 49 enrolled participants. | up to 10 days from index visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental Report of an Adverse Event After a Dose of Study Medication | After each dose of study medication parents reported the presence of any adverse events | data collected after doses occurring up to 10 days after index visit | 

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