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NCT Number: NCT01257503

Homeopathic Cold Remedy for Children Study

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.

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Key information

Conditions

Upper Respiratory Tract Infections Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

2 year–5 year

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

  • 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

Treatment and study plan

Hyland's Cold 'n Cough 4 kids

Drug

5 ml PO q4h prn cold symptoms

Placebo

Drug

liquid made to look like the active homeopathic remedy

Primary outcomes

  1. Change in Severity of Cold Symptoms

    Time frame: Parents assessed change in symptom 1 hour after a dose of study medication

    Parents measured 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. Change in symptom rated from 0 to 6, with 0 indicative of the symptom being much worse and 6 indicative of the symptom being much improved. The unit of analysis for each outcome was doses of medication. Each participant could contribute data on 0 - 10 doses.

Secondary outcomes

  1. Change in Non-specific Symptoms

    Time frame: Parents assessed change in symptom 1 hour after dose of study medication

    Parents measured 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. Change in symptom rated from 0 to 6, with 0 indicative of the symptom being much worse and 6 indicative of the symptom being much improved. The unit of analysis for each outcome was doses of medication. Each participant could contribute data on 0 - 10 doses.

  2. Functional Status

    Time frame: 10 days

    Change in functional status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated 5 activities (vigorous activity, activities that require concentration, activities with family or friends, appetite and sleep) daily for 3 days in their child and again at the 7-10 day follow-up. Functional status scores range from 0 to 15, with higher scores indicative of better functional status.

  3. Health Status

    Time frame: 10 days

    Change in health status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated health status on 1-10 scale with 1 indicating perfect health and 10 indicating very sick. Health status rated on first 3 days of study and again at the 7-10 day follow-up

  4. Overall Symptom Severity

    Time frame: 10 days

    Change in cold symptoms of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents assessed severity of runny nose, cough, sneeze and congestion in their child using a 0-3 scale for each symptom, 0=none to 3= severe. Cold score is sum of scores for each symptom. Parents assessed cold score twice daily on study days 1-3 and at the 7-10 day follow-up

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Standard Homeopathic Company

Registry information

Official study title

Randomized Controlled Trial of a Homeopathic Cold Remedy for Children

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 9, 2010
Registry last updated
Jan 14, 2015

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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