Homeopathic Cold Medicine for Children

Upper Respiratory Tract Infection Clinical Trial

Official title:

Homeopathic Cold Medicine for Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858494
• Other study ID #: 35537
• Status: Completed
• Phase: N/A
• Start date: March 2009
• Est. completion date: October 2009

Study information

• Verified date: July 2018
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Tract Infections
• Upper Respiratory Tract Infection

Intervention

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

Locations

Country	Name	City	State
United States	University of Washington Medical Center-Roosevelt Pediatric Care Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Standard Homeopathic Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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