Homeopathic Cold Medicine for Children

NCT00858494 | Completed Results

• 1 other identifier: 35537
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Upper Respiratory Tract Infection

Keywords

upper respiratory tract infection; children; homeopathic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Parental Report of an Adverse Event After a Dose of Study Medication

  data collected after doses occurring up to 10 days after index visit

Study Arms (1)

homeopathic cold remedy

EXPERIMENTAL

Drug: Hyland's Cold 'n Cough 4 Kids

Interventions

Hyland's Cold 'n Cough 4 Kids DRUG

Liquid homeopathic cold remedy, 5 ml by mouth every 4 hours as needed for relief of cold symptoms for up to 10 days

homeopathic cold remedy

Eligibility Criteria

• Age: 24 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Standard Homeopathic Company: collaborator

Study Sites (1)

University of Washington Medical Center-Roosevelt Pediatric Care Center

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: James A Taylor
• Organization: University of Washington

uncjat@uw.edu

206-616-1206

Study Officials

• James A Taylor, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 9, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: July 26, 2018
• Results First Posted: March 3, 2011

Record last verified: 2018-07

Locations

US (1)