Homeopathic Cold Remedy for Children Study
Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT01257503
Collaborator
Standard Homeopathic Company (Industry)
263
1
2
36
7.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
263 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial of a Homeopathic Cold Remedy for Children
Study Start Date
:
Dec 1, 2010
Actual Primary Completion Date
:
Aug 1, 2013
Actual Study Completion Date
:
Dec 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Homeopathic cold remedy 5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms |
Drug: Hyland's Cold 'n Cough 4 kids
5 ml PO q4h prn cold symptoms
|
| Placebo Comparator: placebo 5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms |
Drug: placebo
liquid made to look like the active homeopathic remedy
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
to 5 Years
Sexes Eligible for Study:
All
Accepts 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
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:
NCT01257503
Other Study ID Numbers:
- 39489-D
First Posted:
Dec 9, 2010
Last Update Posted:
Jan 14, 2015
Last Verified:
Dec 1, 2014
Keywords provided by James Taylor,
Professor,
University of Washington
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Homeopathic Cold Remedy | Placebo |
|---|---|---|
| Arm/Group Description | 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 | 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 |
| Period Title: Overall Study | ||
| STARTED | 133 | 130 |
| Returned Symptom Diaries | 80 | 83 |
| Returned Dosage Logbooks | 75 | 80 |
| COMPLETED | 125 | 119 |
| NOT COMPLETED | 8 | 11 |
Baseline Characteristics
| Arm/Group Title | Homeopathic Cold Remedy | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | Total of all reporting groups |
| Overall Participants | 132 | 129 | 261 |
| Age (Count of Participants) | |||
| <=18 years |
132
100%
|
129
100%
|
261
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
3.4
(1.1)
|
3.5
(1.1)
|
3.5
(1.1)
|
| Gender (participants) [Number] | |||
| Female |
64
48.5%
|
62
48.1%
|
126
48.3%
|
| Male |
67
50.8%
|
67
51.9%
|
134
51.3%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
132
100%
|
129
100%
|
261
100%
|
| baseline cold symptom score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
5.4
(1.8)
|
5.2
(1.8)
|
5.3
(1.8)
|
Outcome Measures
| Title | Change in Severity of Cold Symptoms |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Homeopathic Cold Remedy | Placebo |
|---|---|---|
| Arm/Group Description | 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 | 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 |
| Measure Participants | 75 | 80 |
| Measure doses | 502 | 480 |
| runny nose (n=433, 386) |
3.7
(1.3)
|
3.7
(1.0)
|
| sneeze (n=219, 237) |
3.9
(1.2)
|
3.9
(1.2)
|
| cough (n=399, 373) |
3.8
(1.2)
|
3.8
(1.2)
|
| congestion (n=409, 436) |
3.8
(1.1)
|
3.7
(1.0)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | change in runny nose | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .86 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | generalized estimating equations used to account for multiple doses in same participant | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | change in sneeze | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .89 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | generalized estimating equations used to account for multiple doses in single participant | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | change in cough | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .45 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | generalized estimating equations used to account for multiple doses in single participant | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | change in congestion | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .82 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | generalized estimating equations used to account for multiple doses in single participant | |
| Title | Change in Non-specific Symptoms |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Homeopathic Cold Remedy | Placebo |
|---|---|---|
| Arm/Group Description | 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 | 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 |
| Measure Participants | 75 | 80 |
| Measure doses | 502 | 480 |
| irritability (n= 272, 238) |
3.6
(1.1)
|
3.5
(1.2)
|
| lethargy (n=213, 201) |
3.6
(1.1)
|
3.6
(1.1)
|
| fussiness (n=262, 239) |
3.6
(1.2)
|
3.5
(1.2)
|
| appetite (n=312, 306) |
3.6
(1.0)
|
3.5
(1.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | change in irritability | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .61 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | Generalized estimating equations used to account for multiple doses in single participant. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | change in lethargy | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .97 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | Generalized estimating equations used to account for multiple doses in single participant. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | change in fussiness | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .79 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | Generalized estimating equations used to account for multiple doses in single participant. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | change in appetite | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .81 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | Generalized estimating equations used to account for multiple doses in single participant. | |
| Title | Functional Status |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Homeopathic Cold Remedy | Placebo |
|---|---|---|
| Arm/Group Description | 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 | 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 |
| Measure Participants | 123 | 117 |
| functional status day 1 (n=68, 77) |
11.0
(3.5)
|
10.4
(3.1)
|
| functional status day 2 (n=72, 70) |
11.7
(3.4)
|
11.8
(3.4)
|
| functional status day 3 (n= 62, 68) |
12.7
(3.0)
|
12.5
(3.0)
|
| functional status at follow-up (n=123, 117) |
14.2
(1.7)
|
13.7
(2.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | functional status day 1 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .16 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | functional status day 2 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .70 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | functional status day 3 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .77 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | functional status at 7-10 day follow-up | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .41 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Health Status |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Homeopathic Cold Remedy | Placebo |
|---|---|---|
| Arm/Group Description | 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 | 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 |
| Measure Participants | 125 | 117 |
| health status day 1 (n=75, 77) |
4.4
(1.9)
|
4.9
(2.0)
|
| health status day 2 (n=72,70) |
3.8
(1.9)
|
4.1
(1.8)
|
| health status day 3 (n=63, 69) |
3.2
(2.0)
|
3.4
(1.7)
|
| health status at follow-up (n=125, 117) |
2.5
(1.7)
|
2.5
(1.6)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | health status day 1 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .10 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | health status day 2 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .28 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | health status day 3 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .26 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | health status at follow-up | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .88 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Overall Symptom Severity |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Homeopathic Cold Remedy | Placebo |
|---|---|---|
| Arm/Group Description | 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 | 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 |
| Measure Participants | 123 | 117 |
| day 1 assessment 1 (n=73, 80) |
4.6
(2.2)
|
5.5
(2.3)
|
| day 1 assessment 2 (n=72, 76) |
4.2
(2.4)
|
5.0
(2.0)
|
| day 2 assessment 1 (n=73, 73) |
3.7
(2.2)
|
4.0
(2.0)
|
| day 2 assessment 2 (n=69, 69) |
3.4
(2.3)
|
4.0
(2.2)
|
| day 3 assessment 1 (n=68, 68) |
3.0
(2.5)
|
3.0
(2.3)
|
| day 3 assessment 2 (n= 60, 66) |
2.8
(2.5)
|
3.0
(2.3)
|
| follow-up (n= 123, 117) |
2.4
(2.6)
|
2.0
(2.0)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | cold score day 1 assessment 1 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .02 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | cold score day 1 assessment 2 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .01 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | day 2 assessment 1 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .25 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | cold score day 2 assessment 2 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .15 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | cold score day 3 assessment 1 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .88 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | cold score day 3 assessment 2 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .35 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Homeopathic Cold Remedy, Placebo |
|---|---|---|
| Comments | cold score at 7-10 day follow-up | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .36 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Adverse Events
| Time Frame | Data were collected during the study period and at the follow-up phone call scheduled 7-10 days after enrollment | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||
| Arm/Group Title | Homeopathic Cold Remedy | Placebo | ||
| Arm/Group Description | 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 | 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 | ||
All Cause Mortality |
||||
| Homeopathic Cold Remedy | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Homeopathic Cold Remedy | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/133 (0%) | 0/130 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Homeopathic Cold Remedy | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/133 (0%) | 0/130 (0%) | ||
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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | James A Taylor |
|---|---|
| Organization | University of Washington |
| Phone | 206-616-1206 |
| uncjat@uw.edu |
Responsible Party:
James Taylor,
Professor,
University of Washington
ClinicalTrials.gov Identifier:
NCT01257503
Other Study ID Numbers:
- 39489-D
First Posted:
Dec 9, 2010
Last Update Posted:
Jan 14, 2015
Last Verified:
Dec 1, 2014