Homeopathic Cold Medicine for Children

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT00858494
• Collaborator: Standard Homeopathic Company (Industry)
• Enrollment: 50
• Location: 1
• Arm: 1
• Duration (Months): 7
• Patients Per Site Per Month: 7.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if a commercially available homeopathic cold remedy for children is effective in providing relief from cold symptoms in children 2-5 years old. It is postulated that children will have relief of symptoms after receiving a dose of the cold remedy

Condition or Disease	Intervention/Treatment	Phase
Upper Respiratory Tract Infection	Drug: Hyland's Cold 'n Cough 4 Kids	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Homeopathic Cold Medicine for Children
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: homeopathic cold remedy	Drug: Hyland's Cold 'n Cough 4 Kids; Liquid homeopathic cold remedy, 5 ml by mouth every 4 hours as needed for relief of cold symptoms for up to 10 days

Outcome Measures

Primary Outcome Measures

1. Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy. [up to 10 days from index visit]

   For each dose of study medication, parents indicated which of the symptoms were present (runny nose, cough, nasal congestion, sneezing). Parents rated change in each symptom present one hour after a dose of study medication for up to 6 doses in study logs. Responses were dichotomized as at least some improvement or better (improvement) vs. no improvement or worse. The outcome measure is number of times that improvement in a specific symptom was noted after a dose of the homeopathic remedy. Completed study logs were received from 37 of 49 enrolled participants.

Secondary Outcome Measures

1. Parental Report of an Adverse Event After a Dose of Study Medication [data collected after doses occurring up to 10 days after index visit]

   After each dose of study medication parents reported the presence of any adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 24 Months to 59 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Children 24-59 months old

• Cold/cough symptoms of <7 days duration

• Diagnosed with upper respiratory tract infection by physician or nurse practitioner

• Parent who speaks and reads English

Exclusion Criteria:

• Use of chronic medication other than multivitamins

• History of asthma

• Medication other than acetaminophen or ibuprofen

• Use of homeopathic remedy within preceding 30 days

• Only 1 participant per family

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington Medical Center-Roosevelt Pediatric Care Center	Seattle	Washington	United States	98105

Sponsors and Collaborators

• University of Washington
• Standard Homeopathic Company

Investigators

• Principal Investigator: James A Taylor, MD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: James Taylor, Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT00858494
• Other Study ID Numbers: 35537
• First Posted: Mar 9, 2009
• Last Update Posted: Jul 26, 2018
• Last Verified: Jul 1, 2018

• Keywords provided by James Taylor, Professor, University of Washington: upper respiratory tract infection; children; homeopathic
• Additional relevant MeSH terms: Respiratory Tract Infections

Study Results

Participant Flow

Recruitment Details	Children diagnosed with an upper respiratory tract infection (URI) at a pediatric clinic were recruited for the study from March to September 2009
Pre-assignment Detail	one participant who was enrolled had a positive test for streptococcal pharyngitis at the index visit and was prescribed antibiotics. This participant thus became ineligible.

Arm/Group Title	Homeopathic Cold Remedy
Arm/Group Description	Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
Period Title: Overall Study
STARTED	49
COMPLETED	45
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Homeopathic Cold Remedy
Arm/Group Description	Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
Overall Participants	49
Age (Count of Participants)
<=18 years	49 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	3.5 (1.2)
Sex: Female, Male (Count of Participants)
Female	26 53.1%
Male	23 46.9%
Region of Enrollment (participants) [Number]
United States	49 100%

Outcome Measures

1. Primary Outcome

Title	Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy.
Description	For each dose of study medication, parents indicated which of the symptoms were present (runny nose, cough, nasal congestion, sneezing). Parents rated change in each symptom present one hour after a dose of study medication for up to 6 doses in study logs. Responses were dichotomized as at least some improvement or better (improvement) vs. no improvement or worse. The outcome measure is number of times that improvement in a specific symptom was noted after a dose of the homeopathic remedy. Completed study logs were received from 37 of 49 enrolled participants.
Time Frame	up to 10 days from index visit

Outcome Measure Data

Analysis Population Description

Some symptoms were not present at each dose of the homeopathic remedy. Number of doses at which symptom was present: runny nose: 135, nasal congestion: 152, cough: 154, sneezing 81. The outcome is number of times improvement in each symptom was noted.

Arm/Group Title	Homeopathic Cold Remedy
Arm/Group Description	Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
Measure Participants	37
Measure doses	179
Runny Nose (treated with 135 doses)	83
Cough (treated with 154 doses)	100
Nasal congestion (treated with 152 doses)	94
Sneezing (treated with 81 doses)	52

2. Secondary Outcome

Title	Parental Report of an Adverse Event After a Dose of Study Medication
Description	After each dose of study medication parents reported the presence of any adverse events
Time Frame	data collected after doses occurring up to 10 days after index visit

Outcome Measure Data

Analysis Population Description

Study logs were returned in 37 of 49 enrolled participants. After each dose of study medication, the participant's parent indicated in the study log whether any adverse events were noted.

Arm/Group Title	Homeopathic Cold Remedy
Arm/Group Description	Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
Measure Participants	37
Measure doses	179
any adverse event	3
diarrhea	2
excessive gas	1

Adverse Events

Time Frame	up to 10 days after the index visit
Adverse Event Reporting Description	Parents noted any adverse events after each dose of study medication in study logs that were returned to the research staff. Data on any adverse event were based on information in study logs returned in 37 of 49 participants. Parents were instructed to call research team if a serious adverse event occurred; data on all 49 participants presented.
Arm/Group Title	Homeopathic Cold Remedy
Arm/Group Description	Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
All Cause Mortality
	Homeopathic Cold Remedy
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Homeopathic Cold Remedy
	Affected / at Risk (%)	# Events
Total	0/49 (0%)
Other (Not Including Serious) Adverse Events
	Homeopathic Cold Remedy
	Affected / at Risk (%)	# Events
Total	2/37 (5.4%)
Gastrointestinal disorders
diarrhea	1/37 (2.7%)	2
excessive gas	1/37 (2.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.