Trial Outcomes & Findings for Homeopathic Cold Medicine for Children (NCT NCT00858494)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

up to 10 days from index visit

Results posted on

2018-07-26

Participant Flow

Children diagnosed with an upper respiratory tract infection (URI) at a pediatric clinic were recruited for the study from March to September 2009

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.

Participant milestones

Participant milestones
Measure	Homeopathic Cold Remedy Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
Overall Study STARTED	49
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Homeopathic Cold Medicine for Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Homeopathic Cold Remedy n=49 Participants Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
Age, Categorical <=18 years	49 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	3.5 years STANDARD_DEVIATION 1.2 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 10 days from index visit

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Homeopathic Cold Remedy n=179 doses Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy. Runny Nose (treated with 135 doses)	83 doses
Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy. Cough (treated with 154 doses)	100 doses
Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy. Nasal congestion (treated with 152 doses)	94 doses
Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy. Sneezing (treated with 81 doses)	52 doses

SECONDARY outcome

Timeframe: data collected after doses occurring up to 10 days after index visit

Population: 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.

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

Outcome measures

Outcome measures
Measure	Homeopathic Cold Remedy n=179 doses Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
Parental Report of an Adverse Event After a Dose of Study Medication any adverse event	3 doses
Parental Report of an Adverse Event After a Dose of Study Medication diarrhea	2 doses
Parental Report of an Adverse Event After a Dose of Study Medication excessive gas	1 doses

Adverse Events

Homeopathic Cold Remedy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Homeopathic Cold Remedy n=37 participants at risk；n=49 participants at risk Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
Gastrointestinal disorders diarrhea	2.7% 1/37 • Number of events 2 • up to 10 days after the index visit 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.
Gastrointestinal disorders excessive gas	2.7% 1/37 • Number of events 1 • up to 10 days after the index visit 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.

Additional Information

James A Taylor

University of Washington

Phone: 206-616-1206

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60