Homeopathic Cold Medicine for Children

Not Applicable

Completed

• Conditions: Upper Respiratory Tract Infection
• Interventions: Drug: Hyland's Cold 'n Cough 4 Kids

• Registration Number: NCT00858494
• Lead Sponsor: University of Washington

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-06
• Study First Posted: 2009-03-09
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2010-12-27
• Results First Submitted QC: 2011-03-01
• Results First Posted: 2011-03-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-23
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
homeopathic cold remedy	Hyland's Cold 'n Cough 4 Kids	-

Primary Outcome Measures

Name	Time	Method
Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy.	up to 10 days from index visit	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Washington Medical Center-Roosevelt Pediatric Care Center; 🇺🇸 Seattle, Washington, United States