Common ColdPhase 3NCT00231218
Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers
A Phase 3 study testing dietary supplement--echinacea, propolis, and vitamin c in people with Common Cold and Gastroenteritis, run by The Cleveland Clinic at 1 site in United States.
Trial summary
We hypothesize the herbal preparation will enhance the preschoolers' immune response and when taken prophylactically for 12 weeks will decrease episodes of upper respiratory infections and gastroenteritis in the active versus the control group. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Cold, Gastroenteritis
- What is being tested?
- dietary supplement--echinacea, propolis, and vitamin c
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Mar 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 3-6
Who cannot join
- Cystic fibrosis
- Immunodeficiency
- Bronchopulmonary dysplasia
- Anatomic abnormalities of respiratory tract
- Intestinal malabsorption
- Allergy to sunflower seeds
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Effectiveness of Echinacea, Propolis and Vitamin C in the Prevention of Respiratory Tract Infections and Gastroenteritis in Preschool Age Children: a Prospective Study
We hypothesize the herbal preparation will enhance the preschoolers' immune response and when taken prophylactically for 12 weeks will decrease episodes of upper respiratory infections and gastroenteritis in the active versus the control group.
Read the detailed description
This combination of herbs has been studied only once before in preschoolers. In a study of 430 preschoolers reported in Archives of Pediatric and Adolescent Medicine in March of 2004, a similar preparation with a slightly lower dose of Vitamin C decreased upper respiratory infections by 55% (308 to 138). We are repeating this study to see if our results confirm or contradict those of the previous study.
- Conditions
- Common Cold, Gastroenteritis
- Being tested
- dietary supplement--echinacea, propolis, and vitamin c
- Keywords
- vitamin c, echinacea, propolis, upper respiratory tract infection, common cold, gastroenteritis, dietary supplement, herbal remedy
- Medical subject headings
- Common Cold, Gastroenteritis, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary supplement--echinacea, propolis, and vitamin cDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
upper respiratory tract infections
Secondary outcomes (1)
gastroenteritis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startJan 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 104 participants
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Investigators
- michael l macknin, m.d., Study director, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231218
- Sponsor's protocol ID
- 8348
- Status last verified
- Dec 2006
- First submitted
- 30 Sep 2005
- Last updated
- 14 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effectiveness of Echinacea, Propolis and Vitamin C in the Prevention of Respiratory Tract Infections and Gastroenteritis in Preschool Age Children: a Prospective Study
- ClinicalTrials.gov ID
- NCT00231218
- Acronym / sponsor ID
- 8348
- Conditions
- Common Cold, Gastroenteritis
- Keywords
- vitamin c, echinacea, propolis, upper respiratory tract infection, common cold, gastroenteritis, dietary supplement, herbal remedy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Mar 2006
- First posted
- 4 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize the herbal preparation will enhance the preschoolers' immune response and when taken prophylactically for 12 weeks will decrease episodes of upper respiratory infections and gastroenteritis in the active versus the control group.
Detailed description
This combination of herbs has been studied only once before in preschoolers. In a study of 430 preschoolers reported in Archives of Pediatric and Adolescent Medicine in March of 2004, a similar preparation with a slightly lower dose of Vitamin C decreased upper respiratory infections by 55% (308 to 138). We are repeating this study to see if our results confirm or contradict those of the previous study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age 3-6
Key exclusion criteria (6 listed)
- Cystic fibrosis
- Immunodeficiency
- Bronchopulmonary dysplasia
- Anatomic abnormalities of respiratory tract
- Intestinal malabsorption
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 |
|---|---|---|
| dietary supplement--echinacea, propolis, and vitamin c | Drug | – |
Primary outcome
upper respiratory tract infections
1 secondary outcome
gastroenteritis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2006.
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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.
michael l macknin, m.d. study director
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dietary supplement--echinacea, propolis, and vitamin c in people with Common Cold and Gastroenteritis, run by The Cleveland Clinic 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 1 inclusion and 6 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 Dec 2006. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
upper respiratory tract infections. 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 Dec 2006.