Homeopathic Cold Remedy for Children Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Upper Respiratory Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Homeopathic cold remedy

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

Group Type EXPERIMENTAL

Hyland's Cold 'n Cough 4 kids

Intervention Type DRUG

5 ml PO q4h prn cold symptoms

placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

liquid made to look like the active homeopathic remedy

Interventions

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Hyland's Cold 'n Cough 4 kids

5 ml PO q4h prn cold symptoms

Intervention Type DRUG

placebo

liquid made to look like the active homeopathic remedy

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No