Upper Respiratory Tract InfectionNCT00858494
Homeopathic Cold Medicine for Children
A study testing Hyland's Cold 'n Cough 4 Kids in people with Upper Respiratory Tract Infection, run by University of Washington at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 24 to 59 months
- Conditions the study is for
- Upper Respiratory Tract Infection
- What is being tested?
- Hyland's Cold 'n Cough 4 Kids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Oct 2009
- 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 24 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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
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
- Conditions
- Upper Respiratory Tract Infection
- Being tested
- Hyland's Cold 'n Cough 4 Kids
- Keywords
- upper respiratory tract infection, children, homeopathic
- 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
Liquid homeopathic cold remedy, 5 ml by mouth every 4 hours as needed for relief of cold symptoms for up to 10 days
| Study group | Role | What they receive |
|---|---|---|
| homeopathic cold remedy | Experimental | Not described Receives: Drug: Hyland's Cold 'n Cough 4 Kids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 10 days from index visit
Secondary outcomes (1)
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
Measured: data collected after doses occurring up to 10 days after index visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2009
- Study completionOct 2009
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 InfectionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT00858494
- Sponsor's protocol ID
- 35537
- Status last verified
- Jul 2018
- First submitted
- 5 Mar 2009
- Last updated
- 26 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homeopathic Cold Medicine for Children
- ClinicalTrials.gov ID
- NCT00858494
- Acronym / sponsor ID
- 35537
- Conditions
- Upper Respiratory Tract Infection
- Keywords
- upper respiratory tract infection, children, homeopathic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Standard Homeopathic Company
- Study start
- Mar 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 9 Mar 2009 (estimated)
- Results
- Posted 3 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| homeopathic cold remedy | Experimental | Drug: Hyland's Cold 'n Cough 4 Kids |
Who may qualify
- Ages
- 24 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 KidsLiquid homeopathic cold remedy, 5 ml by mouth every 4 hours as needed for relief of cold symptoms for up to 10 days | Drug | homeopathic cold remedy |
Primary outcome
Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy.
Time frame: 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.
1 secondary outcome
Parental Report of an Adverse Event After a Dose of Study Medication
Time frame: data collected after doses occurring up to 10 days after index visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- 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 Infection, 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 4 inclusion and 5 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 26 Jul 2018. 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. 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 3 Mar 2011). 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?
Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy. (time frame: up to 10 days from index visit). 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 26 Jul 2018.