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| Name | Class |
|---|---|
| Standard Homeopathic Company | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Homeopathic cold remedy | Experimental | 5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms |
|
| placebo | Placebo Comparator | 5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyland's Cold 'n Cough 4 kids | Drug | 5 ml PO q4h prn cold symptoms |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Parents assessed change in symptom 1 hour after a dose of study medication |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James A Taylor, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Medical Center- Roosevelt Pediatric Care Center | Seattle | Washington | 98105 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Eligible patients enrolled. Age data were analyzed on 127 participants in the placebo group since exact data were missing for 2 participants
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | exact age information missing on 2 participants in placebo group, noted to be 2-5 years old |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Parents assessed change in symptom 1 hour after a dose of study medication | doses | Participants |
|
Data were collected during the study period and at the follow-up phone call scheduled 7-10 days after enrollment
Parents were asked to record any side effects after each dose of study medications. Parents also asked about side effects during follow-up phone call.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James A Taylor | University of Washington | 206-616-1206 | uncjat@uw.edu |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| placebo |
| Drug |
liquid made to look like the active homeopathic remedy |
|
| Parents assessed change in symptom 1 hour after dose of study medication |
| 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. | 10 days |
| 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 | 10 days |
| 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 | 10 days |
| strep culture positive at enrollment |
|
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
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Gender information missing on 1 participant randomized to the homeopathic cold remedy group | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| baseline cold symptom score | sum of scores for runny nose severity, sneeze severity, cough severity and congestion severity rated by parent at study entry. For each symptom, possible scores range from 0 to 3, with 3 indicating most severe. Baseline cold score missing on 1 participant in the homeopathic cold remedy group | Mean | Standard Deviation | units on a scale |
|
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 |
| OG001 | 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 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Parents assessed change in symptom 1 hour after dose of study medication | doses | Participants |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 10 days |
|
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | units on a scale | 10 days |
|
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | units on a scale | 10 days |
|
|
|
|
| 0 |
| 133 |
| 0 |
| 133 |
| EG001 | 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 | 0 | 130 | 0 | 130 |
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| fussiness (n=262, 239) |
|
| appetite (n=312, 306) |
|
| Regression, Linear |
Generalized estimating equations used to account for multiple doses in single participant. |
| .97 |
| 2-Sided |
| No |
| Superiority or Other |
| change in fussiness | Regression, Linear | Generalized estimating equations used to account for multiple doses in single participant. | .79 | 2-Sided | No | Superiority or Other |
| change in appetite | Regression, Linear | Generalized estimating equations used to account for multiple doses in single participant. | .81 | 2-Sided | No | Superiority or Other |
| functional status day 3 (n= 62, 68) |
|
| functional status at follow-up (n=123, 117) |
|
| .70 |
| 2-Sided |
| No |
| Superiority or Other |
| functional status day 3 | Wilcoxon (Mann-Whitney) | .77 | 2-Sided | No | Superiority or Other |
| functional status at 7-10 day follow-up | Wilcoxon (Mann-Whitney) | .41 | 2-Sided | No | Superiority or Other |
| health status day 3 (n=63, 69) |
|
| health status at follow-up (n=125, 117) |
|
| .28 |
| 2-Sided |
| No |
| Superiority or Other |
| health status day 3 | Wilcoxon (Mann-Whitney) | .26 | 2-Sided | No | Superiority or Other |
| health status at follow-up | Wilcoxon (Mann-Whitney) | .88 | 2-Sided | No | Superiority or Other |
| day 2 assessment 1 (n=73, 73) |
|
| day 2 assessment 2 (n=69, 69) |
|
| day 3 assessment 1 (n=68, 68) |
|
| day 3 assessment 2 (n= 60, 66) |
|
| follow-up (n= 123, 117) |
|
| .01 |
| 2-Sided |
| No |
| Superiority or Other |
| day 2 assessment 1 | Wilcoxon (Mann-Whitney) | .25 | 2-Sided | No | Superiority or Other |
| cold score day 2 assessment 2 | Wilcoxon (Mann-Whitney) | .15 | 2-Sided | No | Superiority or Other |
| cold score day 3 assessment 1 | Wilcoxon (Mann-Whitney) | .88 | 2-Sided | No | Superiority or Other |
| cold score day 3 assessment 2 | Wilcoxon (Mann-Whitney) | .35 | 2-Sided | No | Superiority or Other |
| cold score at 7-10 day follow-up | Wilcoxon (Mann-Whitney) | .36 | 2-Sided | No | Superiority or Other |