Homeopathic Cold Remedy for Children Study

NCT01257503 | Completed Results

• 1 other identifier: 39489-D
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Respiratory Tract Infections

Keywords

children; upper respiratory tract infections; homeopathy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change in Non-specific Symptoms

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

• Functional Status

  10 days

• Health Status

  10 days

• Overall Symptom Severity

  10 days

Study Arms (2)

Homeopathic cold remedy

EXPERIMENTAL

5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms

Drug: Hyland's Cold 'n Cough 4 kids

placebo

PLACEBO COMPARATOR

5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms

Drug: placebo

Interventions

Hyland's Cold 'n Cough 4 kids DRUG

5 ml PO q4h prn cold symptoms

Homeopathic cold remedy

placebo DRUG

liquid made to look like the active homeopathic remedy

placebo

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

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: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 9, 2010
• Study Start: December 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 14, 2015
• Results First Posted: January 2, 2015

Record last verified: 2014-12

Locations

US (1)