Upper Respiratory Tract InfectionsNCT01257503
Homeopathic Cold Remedy for Children Study
A study testing Hyland's Cold 'n Cough 4 kids in people with Upper Respiratory Tract Infections, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Upper Respiratory Tract Infections
- What is being tested?
- Hyland's Cold 'n Cough 4 kids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- clinical diagnosis of upper respiratory tract infection
- duration of symptoms < 7 days
- Parent who speaks English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center- Roosevelt Pediatric Care Center
Seattle, Washington, 98105
About this study
Official title: Randomized Controlled Trial of a Homeopathic Cold Remedy for Children
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.
- Conditions
- Upper Respiratory Tract Infections
- Being tested
- Hyland's Cold 'n Cough 4 kids, placebo
- Keywords
- children, upper respiratory tract infections, homeopathy
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyland's Cold 'n Cough 4 kidsDrug
5 ml PO q4h prn cold symptoms
placeboDrug
liquid made to look like the active homeopathic remedy
| Study group | Role | What they receive |
|---|---|---|
| Homeopathic cold remedy | Experimental | 5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms Receives: Drug: Hyland's Cold 'n Cough 4 kids |
| placebo | Placebo comparator | 5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Parents assessed change in symptom 1 hour after a dose of study medication
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionAug 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Standard Homeopathic Company
- Responsible party
- Principal investigator, James Taylor, University of Washington
- Investigators
- James A Taylor, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257503
- Sponsor's protocol ID
- 39489-D
- Status last verified
- Dec 2014
- First submitted
- 8 Dec 2010
- Last updated
- 14 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Homeopathic Cold Remedy for Children
- ClinicalTrials.gov ID
- NCT01257503
- Acronym / sponsor ID
- 39489-D
- Conditions
- Upper Respiratory Tract Infections
- Keywords
- children, upper respiratory tract infections, homeopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Standard Homeopathic Company
- Study start
- Dec 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Dec 2010 (estimated)
- Results
- Posted 2 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Homeopathic cold remedy | Experimental | Drug: Hyland's Cold 'n Cough 4 kids5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms |
| placebo | Placebo comparator | Drug: placebo5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- clinical diagnosis of upper respiratory tract infection
- duration of symptoms < 7 days
- Parent who speaks English
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyland's Cold 'n Cough 4 kids5 ml PO q4h prn cold symptoms | Drug | Homeopathic cold remedy |
| placeboliquid made to look like the active homeopathic remedy | Drug | placebo |
Primary outcome
Change in Severity of Cold Symptoms
Time frame: 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.
4 secondary outcomes
Change in Non-specific Symptoms
Time frame: Parents assessed change in symptom 1 hour after dose of study medication
Functional Status
Time frame: 10 days
Health Status
Time frame: 10 days
Overall Symptom Severity
Time frame: 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James A Taylor, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyland's Cold 'n Cough 4 kids in people with Upper Respiratory Tract Infections, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Severity of Cold Symptoms (time frame: Parents assessed change in symptom 1 hour after a dose of study medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015; AzTrials last refreshed its copy on 31 Oct 2026.