Homeopathic Cold Remedy for Children Study

This study has been completed.
Sponsor:
Collaborator:
Standard Homeopathic Company
Information provided by (Responsible Party):
James Taylor, University of Washington
ClinicalTrials.gov Identifier:
NCT01257503
First received: December 8, 2010
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Upper Respiratory Tract Infections
Drug: Hyland's Cold 'n Cough 4 kids
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of a Homeopathic Cold Remedy for Children

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Change in severity of cold symptoms [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Parents will measure 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.


Secondary Outcome Measures:
  • Change in non-specific symptoms [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Parents will measure 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.

  • Functional status [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Change in functional status of child during the 7-10 days after the index visit for an upper respiratory tract infection

  • health status [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Change in health status of child during the 7-10 days after the index visit for an upper respiratory tract infection

  • overall symptom severity [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Change in cold symptoms of child during the 7-10 days after the index visit for an upper respiratory tract infection


Enrollment: 263
Study Start Date: December 2010
Study Completion Date: December 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Homeopathic cold remedy
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
5 ml PO q4h prn cold symptoms
Placebo Comparator: placebo
5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms
Drug: placebo
liquid made to look like the active homeopathic remedy

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257503

Locations
United States, Washington
University of Washington Medical Center- Roosevelt Pediatric Care Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
Standard Homeopathic Company
Investigators
Principal Investigator: James A Taylor, MD University of Washington
  More Information

No publications provided

Responsible Party: James Taylor, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01257503     History of Changes
Other Study ID Numbers: 39489-D
Study First Received: December 8, 2010
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
children
upper respiratory tract infections
homeopathy

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 14, 2014