Upper Respiratory Tract InfectionsNCT01396889
Impact of Echinacea as Prophilaxis for Upper Respiratory Tract Infections in Children 1-5 Years
A study testing Echinacea in people with Upper Respiratory Tract Infections, run by Hormozgan University of Medical Sciences at 1 site in Iran.
Trial summary
Acute upper respiratory tract infections are the most commmon infections in children and are associated with complications such as acute otitis media, sinusitis and pneumonia. Echinacea is widely used for treatment of upper respiratoty tract infections. Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infections
- What is being tested?
- Echinacea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- May 2010to Jul 2011
- Phase
- Interventional
- 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 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Childrens 1-5 years old
Who cannot join
- Wheezing in previous 3 months requiring bronchodilatator
- History of hyperactive reactive airway
- using steroid or Echinacea
- chronic pulmonary of cardiac disease
- Acute respiratory disease within one week before study
- Allergic rhinitis
- Allergy to Echinacea
- avoiding to participate in the study
Trial locations and contacts
1 site in 1 country.
Iran1 site
Hormozgan University of Medical Sciences (HUMS)
Bandar Abbas, Hormozgan
About this study
Official title: Impact of Echinacea as Prophilaxis for Upper Respiratory Tract Infections in Children 1-5 Years in Bandarabbas Children' Hospital
Acute upper respiratory tract infections are the most commmon infections in children and are associated with complications such as acute otitis media, sinusitis and pneumonia. Echinacea is widely used for treatment of upper respiratoty tract infections. The aim of this study is to evaluate its efficacy as prophilaxis in children 1-5 years old.
- Conditions
- Upper Respiratory Tract Infections
- Being tested
- Echinacea, Placebo
- Keywords
- Upper Respiratory Tract Infections, Echinacea, viral infections
- Medical subject headings
- Respiratory Tract Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchinaceaDrug
Also called American Cone Flower
0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old
PlaceboDrug
Placebo (0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old) for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Echinacea | Experimental | 0.5ml daily for children 1-2 years old and 2ml daily for children2-5 years old for 3 months Receives: Drug: Echinacea |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of upper respiratory tract infection diagnosed by physician according to history and physical examination and laboratory tests if was necessary
Measured: 6 months
Secondary outcomes (1)
Drug side effects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startMay 2010
- Primary completionDec 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hormozgan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Roya Firoozi, Resident, Principal investigator, Hormozgan University of Medical Sciences (HUMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396889
- Sponsor's protocol ID
- Echinacea in URIs
- Status last verified
- May 2010
- First submitted
- 18 Jul 2011
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Echinacea as Prophilaxis for Upper Respiratory Tract Infections in Children 1-5 Years in Bandarabbas Children' Hospital
- ClinicalTrials.gov ID
- NCT01396889
- Acronym / sponsor ID
- Echinacea in URIs
- Conditions
- Upper Respiratory Tract Infections
- Keywords
- Upper Respiratory Tract Infections, Echinacea, viral infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hormozgan University of Medical SciencesUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 19 Jul 2011 (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.
Acute upper respiratory tract infections are the most commmon infections in children and are associated with complications such as acute otitis media, sinusitis and pneumonia. Echinacea is widely used for treatment of upper respiratoty tract infections. The aim of this study is to evaluate its efficacy as prophilaxis in children 1-5 years old.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echinacea | Experimental | Drug: Echinacea0.5ml daily for children 1-2 years old and 2ml daily for children2-5 years old for 3 months |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Childrens 1-5 years old
Key exclusion criteria (8 listed)
- Wheezing in previous 3 months requiring bronchodilatator
- History of hyperactive reactive airway
- using steroid or Echinacea
- chronic pulmonary of cardiac disease
- Acute respiratory disease within one week before study
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 |
|---|---|---|
| EchinaceaAlso: American Cone Flower0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old | Drug | Echinacea |
| PlaceboPlacebo (0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old) for 3 months | Drug | Placebo |
Primary outcome
occurrence of upper respiratory tract infection diagnosed by physician according to history and physical examination and laboratory tests if was necessary
Time frame: 6 months
1 secondary outcome
Drug side effects
Time frame: 6 months
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 22 Jul 2011.
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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.
Roya Firoozi, Resident principal investigator
Hormozgan University of Medical Sciences (HUMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echinacea in people with Upper Respiratory Tract Infections, run by Hormozgan University of Medical Sciences at 1 site in Iran.
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 8 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 22 Jul 2011. 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 Iran. 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?
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?
occurrence of upper respiratory tract infection diagnosed by physician according to history and physical examination and laboratory tests if was necessary (time frame: 6 months). 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 22 Jul 2011; AzTrials last refreshed its copy on 8 Nov 2026.