Upper Respiratory Tract Infection
Conditions
Keywords
upper respiratory tract infection, children, homeopathic
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
Interventions
Liquid homeopathic cold remedy, 5 ml by mouth every 4 hours as needed for relief of cold symptoms for up to 10 days
Sponsors
Standard Homeopathic Company
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Months to 59 Months
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 49 |
| Total | 49 |
Baseline characteristics
| Characteristic | Homeopathic Cold Remedy |
|---|---|
| Age, Categorical <=18 years | 49 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 3.5 years STANDARD_DEVIATION 1.2 |
| Region of Enrollment United States | 49 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 37 |
| serious Total, serious adverse events | 0 / 49 |
Outcome results
Primary
Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy.
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Homeopathic Cold Remedy | 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 |
| Homeopathic Cold Remedy | 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 |
| Homeopathic Cold Remedy | 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 |
| Homeopathic Cold Remedy | 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
Parental Report of an Adverse Event After a Dose of Study Medication
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Homeopathic Cold Remedy | Parental Report of an Adverse Event After a Dose of Study Medication | any adverse event | 3 doses |
| Homeopathic Cold Remedy | Parental Report of an Adverse Event After a Dose of Study Medication | diarrhea | 2 doses |
| Homeopathic Cold Remedy | Parental Report of an Adverse Event After a Dose of Study Medication | excessive gas | 1 doses |