Back to resultsHomeopathic Cold Medicine for Children
Primary Purpose
Upper Respiratory Tract Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyland's Cold 'n Cough 4 Kids
Sponsored by
About this trial
This is an interventional treatment trial for Upper Respiratory Tract Infection focused on measuring upper respiratory tract infection, children, homeopathic
Eligibility Criteria
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
Sites / Locations
- University of Washington Medical Center-Roosevelt Pediatric Care Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
homeopathic cold remedy
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00858494
First Posted
March 5, 2009
Last Updated
July 23, 2018
Sponsor
University of Washington
Collaborators
Standard Homeopathic Company
1. Study Identification
Unique Protocol Identification Number
NCT00858494
Brief Title
Homeopathic Cold Medicine for Children
Official Title
Homeopathic Cold Medicine for Children
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Standard Homeopathic Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infection
Keywords
upper respiratory tract infection, children, homeopathic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
homeopathic cold remedy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Hyland's Cold 'n Cough 4 Kids
Intervention Description
Liquid homeopathic cold remedy, 5 ml by mouth every 4 hours as needed for relief of cold symptoms for up to 10 days
Primary Outcome Measure Information:
Title
Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy.
Description
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.
Time Frame
up to 10 days from index visit
Secondary Outcome Measure Information:
Title
Parental Report of an Adverse Event After a Dose of Study Medication
Description
After each dose of study medication parents reported the presence of any adverse events
Time Frame
data collected after doses occurring up to 10 days after index visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A Taylor, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Medical Center-Roosevelt Pediatric Care Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
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Homeopathic Cold Medicine for Children
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