Upper Respiratory Tract Infections
Conditions
Keywords
children, upper respiratory tract infections, homeopathy
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.
Interventions
5 ml PO q4h prn cold symptoms
DRUGplacebo
liquid made to look like the active homeopathic remedy
Sponsors
Standard Homeopathic Company
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Severity of Cold Symptoms | Parents assessed change in symptom 1 hour after a dose of study medication | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Non-specific Symptoms | Parents assessed change in symptom 1 hour after dose of study medication | Parents measured change in severity of irritability, lethargy, fussiness, and appetite 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. |
| Functional Status | 10 days | Change in functional status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated 5 activities (vigorous activity, activities that require concentration, activities with family or friends, appetite and sleep) daily for 3 days in their child and again at the 7-10 day follow-up. Functional status scores range from 0 to 15, with higher scores indicative of better functional status. |
| Health Status | 10 days | Change in health status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated health status on 1-10 scale with 1 indicating perfect health and 10 indicating very sick. Health status rated on first 3 days of study and again at the 7-10 day follow-up |
| Overall Symptom Severity | 10 days | Change in cold symptoms of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents assessed severity of runny nose, cough, sneeze and congestion in their child using a 0-3 scale for each symptom, 0=none to 3= severe. Cold score is sum of scores for each symptom. Parents assessed cold score twice daily on study days 1-3 and at the 7-10 day follow-up |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Homeopathic Cold Remedy 5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms
Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms | 132 |
| Placebo 5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms
placebo: liquid made to look like the active homeopathic remedy | 129 |
| Total | 261 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 10 |
| Overall Study | Over 5 years old at enrollment | 0 | 1 |
| Overall Study | strep culture positive at enrollment | 1 | 0 |
Baseline characteristics
| Characteristic | Homeopathic Cold Remedy | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 132 Participants | 129 Participants | 261 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 3.4 years STANDARD_DEVIATION 1.1 | 3.5 years STANDARD_DEVIATION 1.1 | 3.5 years STANDARD_DEVIATION 1.1 |
| baseline cold symptom score | 5.4 units on a scale STANDARD_DEVIATION 1.8 | 5.2 units on a scale STANDARD_DEVIATION 1.8 | 5.3 units on a scale STANDARD_DEVIATION 1.8 |
| Gender Female | 64 participants | 62 participants | 126 participants |
| Gender Male | 67 participants | 67 participants | 134 participants |
| Region of Enrollment United States | 132 participants | 129 participants | 261 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 133 | 0 / 130 |
| serious Total, serious adverse events | 0 / 133 | 0 / 130 |
Outcome results
Primary
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.
Time frame: Parents assessed change in symptom 1 hour after a dose of study medication
Population: Data are from logbooks returned by participants. For each participant, data on response to up to 10 doses were collected. Not every symptom was present at each dose. Change in runny nose assessed after 819 doses, sneeze 456 doses, cough 772 doses, congestion 845. For category title, first n= homeopathic cold remedy, second n= placebo.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Homeopathic Cold Remedy | Change in Severity of Cold Symptoms | runny nose (n=433, 386) | 3.7 units on a scale | Standard Deviation 1.3 |
| Homeopathic Cold Remedy | Change in Severity of Cold Symptoms | sneeze (n=219, 237) | 3.9 units on a scale | Standard Deviation 1.2 |
| Homeopathic Cold Remedy | Change in Severity of Cold Symptoms | cough (n=399, 373) | 3.8 units on a scale | Standard Deviation 1.2 |
| Homeopathic Cold Remedy | Change in Severity of Cold Symptoms | congestion (n=409, 436) | 3.8 units on a scale | Standard Deviation 1.1 |
| Placebo | Change in Severity of Cold Symptoms | congestion (n=409, 436) | 3.7 units on a scale | Standard Deviation 1 |
| Placebo | Change in Severity of Cold Symptoms | runny nose (n=433, 386) | 3.7 units on a scale | Standard Deviation 1 |
| Placebo | Change in Severity of Cold Symptoms | cough (n=399, 373) | 3.8 units on a scale | Standard Deviation 1.2 |
| Placebo | Change in Severity of Cold Symptoms | sneeze (n=219, 237) | 3.9 units on a scale | Standard Deviation 1.2 |
Comparison: change in runny nosep-value: 0.86Regression, Linear
Comparison: change in sneezep-value: 0.89Regression, Linear
Comparison: change in coughp-value: 0.45Regression, Linear
Comparison: change in congestionp-value: 0.82Regression, Linear
Secondary
Change in Non-specific Symptoms
Parents measured change in severity of irritability, lethargy, fussiness, and appetite 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.
Time frame: Parents assessed change in symptom 1 hour after dose of study medication
Population: Data are from logbooks returned by participants. For each participant, data on response to up to 10 doses were collected. Not every symptom was present at each dose. Change in irritability assessed after 510 doses, lethargy 414, fussiness 501, appetite 618. For category title, first n= homeopathic cold remedy, second n= placebo.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Homeopathic Cold Remedy | Change in Non-specific Symptoms | irritability (n= 272, 238) | 3.6 units on a scale | Standard Deviation 1.1 |
| Homeopathic Cold Remedy | Change in Non-specific Symptoms | lethargy (n=213, 201) | 3.6 units on a scale | Standard Deviation 1.1 |
| Homeopathic Cold Remedy | Change in Non-specific Symptoms | fussiness (n=262, 239) | 3.6 units on a scale | Standard Deviation 1.2 |
| Homeopathic Cold Remedy | Change in Non-specific Symptoms | appetite (n=312, 306) | 3.6 units on a scale | Standard Deviation 1 |
| Placebo | Change in Non-specific Symptoms | appetite (n=312, 306) | 3.5 units on a scale | Standard Deviation 1.1 |
| Placebo | Change in Non-specific Symptoms | irritability (n= 272, 238) | 3.5 units on a scale | Standard Deviation 1.2 |
| Placebo | Change in Non-specific Symptoms | fussiness (n=262, 239) | 3.5 units on a scale | Standard Deviation 1.2 |
| Placebo | Change in Non-specific Symptoms | lethargy (n=213, 201) | 3.6 units on a scale | Standard Deviation 1.1 |
Comparison: change in irritabilityp-value: 0.61Regression, Linear
Comparison: change in lethargyp-value: 0.97Regression, Linear
Comparison: change in fussinessp-value: 0.79Regression, Linear
Comparison: change in appetitep-value: 0.81Regression, Linear
Secondary
Functional Status
Change in functional status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated 5 activities (vigorous activity, activities that require concentration, activities with family or friends, appetite and sleep) daily for 3 days in their child and again at the 7-10 day follow-up. Functional status scores range from 0 to 15, with higher scores indicative of better functional status.
Time frame: 10 days
Population: Participants who completed follow-up and had valid data for functional outcome. Data on functional status analyzed on days 1-3 for participants who returned symptom diaries including 145 on day 1, 142 on day 2 and 130 on day 3. For category title, first n= homeopathic cold remedy, second n= placebo.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Homeopathic Cold Remedy | Functional Status | functional status day 1 (n=68, 77) | 11.0 units on a scale | Standard Deviation 3.5 |
| Homeopathic Cold Remedy | Functional Status | functional status day 2 (n=72, 70) | 11.7 units on a scale | Standard Deviation 3.4 |
| Homeopathic Cold Remedy | Functional Status | functional status day 3 (n= 62, 68) | 12.7 units on a scale | Standard Deviation 3 |
| Homeopathic Cold Remedy | Functional Status | functional status at follow-up (n=123, 117) | 14.2 units on a scale | Standard Deviation 1.7 |
| Placebo | Functional Status | functional status at follow-up (n=123, 117) | 13.7 units on a scale | Standard Deviation 2.7 |
| Placebo | Functional Status | functional status day 1 (n=68, 77) | 10.4 units on a scale | Standard Deviation 3.1 |
| Placebo | Functional Status | functional status day 3 (n= 62, 68) | 12.5 units on a scale | Standard Deviation 3 |
| Placebo | Functional Status | functional status day 2 (n=72, 70) | 11.8 units on a scale | Standard Deviation 3.4 |
Comparison: functional status day 1p-value: 0.16Wilcoxon (Mann-Whitney)
Comparison: functional status day 2p-value: 0.7Wilcoxon (Mann-Whitney)
Comparison: functional status day 3p-value: 0.77Wilcoxon (Mann-Whitney)
Comparison: functional status at 7-10 day follow-upp-value: 0.41Wilcoxon (Mann-Whitney)
Secondary
Health Status
Change in health status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated health status on 1-10 scale with 1 indicating perfect health and 10 indicating very sick. Health status rated on first 3 days of study and again at the 7-10 day follow-up
Time frame: 10 days
Population: Health status on those with follow-up data and a valid score for health status. Health status also assessed in participants who returned symptom diaries including 152 on day 1, 142 on day 2 and 132 on day 3. For category title, first n= homeopathic cold remedy, second n= placebo.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Homeopathic Cold Remedy | Health Status | health status day 1 (n=75, 77) | 4.4 units on a scale | Standard Deviation 1.9 |
| Homeopathic Cold Remedy | Health Status | health status day 2 (n=72,70) | 3.8 units on a scale | Standard Deviation 1.9 |
| Homeopathic Cold Remedy | Health Status | health status day 3 (n=63, 69) | 3.2 units on a scale | Standard Deviation 2 |
| Homeopathic Cold Remedy | Health Status | health status at follow-up (n=125, 117) | 2.5 units on a scale | Standard Deviation 1.7 |
| Placebo | Health Status | health status at follow-up (n=125, 117) | 2.5 units on a scale | Standard Deviation 1.6 |
| Placebo | Health Status | health status day 1 (n=75, 77) | 4.9 units on a scale | Standard Deviation 2 |
| Placebo | Health Status | health status day 3 (n=63, 69) | 3.4 units on a scale | Standard Deviation 1.7 |
| Placebo | Health Status | health status day 2 (n=72,70) | 4.1 units on a scale | Standard Deviation 1.8 |
Comparison: health status day 1p-value: 0.1Wilcoxon (Mann-Whitney)
Comparison: health status day 2p-value: 0.28Wilcoxon (Mann-Whitney)
Comparison: health status day 3p-value: 0.26Wilcoxon (Mann-Whitney)
Comparison: health status at follow-upp-value: 0.88Wilcoxon (Mann-Whitney)
Secondary
Overall Symptom Severity
Change in cold symptoms of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents assessed severity of runny nose, cough, sneeze and congestion in their child using a 0-3 scale for each symptom, 0=none to 3= severe. Cold score is sum of scores for each symptom. Parents assessed cold score twice daily on study days 1-3 and at the 7-10 day follow-up
Time frame: 10 days
Population: Data analyzed on participant who completed 7-10 day follow-up and had valid cold scores. Data also analyzed twice daily on those participants who returned symptom diaries including: day 1 (153, 148), day 2 (146,138), and day 3 (136, 126). For category title, first n= homeopathic cold remedy, second n= placebo.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Homeopathic Cold Remedy | Overall Symptom Severity | day 2 assessment 1 (n=73, 73) | 3.7 units on a scale | Standard Deviation 2.2 |
| Homeopathic Cold Remedy | Overall Symptom Severity | day 3 assessment 1 (n=68, 68) | 3.0 units on a scale | Standard Deviation 2.5 |
| Homeopathic Cold Remedy | Overall Symptom Severity | day 1 assessment 2 (n=72, 76) | 4.2 units on a scale | Standard Deviation 2.4 |
| Homeopathic Cold Remedy | Overall Symptom Severity | day 3 assessment 2 (n= 60, 66) | 2.8 units on a scale | Standard Deviation 2.5 |
| Homeopathic Cold Remedy | Overall Symptom Severity | day 2 assessment 2 (n=69, 69) | 3.4 units on a scale | Standard Deviation 2.3 |
| Homeopathic Cold Remedy | Overall Symptom Severity | follow-up (n= 123, 117) | 2.4 units on a scale | Standard Deviation 2.6 |
| Homeopathic Cold Remedy | Overall Symptom Severity | day 1 assessment 1 (n=73, 80) | 4.6 units on a scale | Standard Deviation 2.2 |
| Placebo | Overall Symptom Severity | follow-up (n= 123, 117) | 2.0 units on a scale | Standard Deviation 2 |
| Placebo | Overall Symptom Severity | day 1 assessment 1 (n=73, 80) | 5.5 units on a scale | Standard Deviation 2.3 |
| Placebo | Overall Symptom Severity | day 1 assessment 2 (n=72, 76) | 5.0 units on a scale | Standard Deviation 2 |
| Placebo | Overall Symptom Severity | day 2 assessment 1 (n=73, 73) | 4.0 units on a scale | Standard Deviation 2 |
| Placebo | Overall Symptom Severity | day 2 assessment 2 (n=69, 69) | 4.0 units on a scale | Standard Deviation 2.2 |
| Placebo | Overall Symptom Severity | day 3 assessment 1 (n=68, 68) | 3.0 units on a scale | Standard Deviation 2.3 |
| Placebo | Overall Symptom Severity | day 3 assessment 2 (n= 60, 66) | 3.0 units on a scale | Standard Deviation 2.3 |
Comparison: cold score day 1 assessment 1p-value: 0.02Wilcoxon (Mann-Whitney)
Comparison: cold score day 1 assessment 2p-value: 0.01Wilcoxon (Mann-Whitney)
Comparison: day 2 assessment 1p-value: 0.25Wilcoxon (Mann-Whitney)
Comparison: cold score day 2 assessment 2p-value: 0.15Wilcoxon (Mann-Whitney)
Comparison: cold score day 3 assessment 1p-value: 0.88Wilcoxon (Mann-Whitney)
Comparison: cold score day 3 assessment 2p-value: 0.35Wilcoxon (Mann-Whitney)
Comparison: cold score at 7-10 day follow-upp-value: 0.36Wilcoxon (Mann-Whitney)