Homeopathic Cold Remedy for Children Study

Not Applicable

Completed

• Conditions: Upper Respiratory Tract Infections
• Interventions: Drug: placebo; Drug: Hyland's Cold 'n Cough 4 kids

• Registration Number: NCT01257503
• Lead Sponsor: University of Washington

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-08
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Primary Completion: 2013-08
• Study Completion: 2013-12
• Status Verified: 2014-12
• Results First Submitted: 2014-12-09
• Results First Submitted QC: 2014-12-18
• Last Update Submitted: 2014-12-31
• Results First Posted: 2015-01-02
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

Inclusion Criteria

• clinical diagnosis of upper respiratory tract infection
• duration of symptoms < 7 days
• Parent who speaks English

Read More

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms
Homeopathic cold remedy	Hyland's Cold 'n Cough 4 kids	5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms

Primary Outcome Measures

Name	Time	Method
Change in Severity of Cold Symptoms	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 Outcome Measures

Name	Time	Method
Change in Non-specific Symptoms	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.
Functional Status	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.
Health Status	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
Overall Symptom Severity	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

Trial Locations

Locations (1)

University of Washington Medical Center- Roosevelt Pediatric Care Center; 🇺🇸 Seattle, Washington, United States