Homeopathic Cold Medicine for Children

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

Study Overview

• Status: Completed
• Conditions: Upper Respiratory Tract Infection
• Intervention / Treatment: Drug: Hyland's Cold 'n Cough 4 Kids

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington Medical Center-Roosevelt Pediatric Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Standard Homeopathic Company

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: March 5, 2009
• First Submitted That Met QC Criteria: March 6, 2009
• First Posted (Estimate): March 9, 2009

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 23, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: children; upper respiratory tract infection; homeopathic
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 35537