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Completed

NCT Number: NCT00858494

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

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Key information

Conditions

Upper Respiratory Tract Infection Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

24 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington Medical Center-Roosevelt Pediatric Care Center

Seattle, Washington, 98105, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy.

    Time frame: up to 10 days from index visit

    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 outcomes

  1. Parental Report of an Adverse Event After a Dose of Study Medication

    Time frame: data collected after doses occurring up to 10 days after index visit

    After each dose of study medication parents reported the presence of any adverse events

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Standard Homeopathic Company

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 9, 2009
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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