Homeopathic Cold Remedy for Children Study

Upper Respiratory Tract Infections Clinical Trial

Official title:

Randomized Controlled Trial of a Homeopathic Cold Remedy for Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257503
• Other study ID #: 39489-D
• Status: Completed
• Phase: N/A
• First received: December 8, 2010
• Last updated: December 31, 2014
• Start date: December 2010
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Tract Infections
• Upper Respiratory Tract Infections

Intervention

Drug:
• Hyland's Cold 'n Cough 4 kids
5 ml PO q4h prn cold symptoms
• placebo
liquid made to look like the active homeopathic remedy

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	Change in Severity of Cold Symptoms	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.	Parents assessed change in symptom 1 hour after a dose of study medication	No
Secondary	Change in Non-specific Symptoms	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.	Parents assessed change in symptom 1 hour after dose of study medication	No
Secondary	Functional Status	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.	10 days	No
Secondary	Health Status	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	10 days	No
Secondary	Overall Symptom Severity	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	10 days	No