Common ColdPhase 2NCT00032500
Evaluation of Echinacea for the Common Cold
A Phase 2 study testing Echinacea in people with Common Cold, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether three Echinacea preparations with different chemical compositions are effective for prevention or treatment of the common cold. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Common Cold
- What is being tested?
- Echinacea
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to May 2004
- Phase
- Phase 2
- 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 Any age
- Child, Adult, Older adult
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia, Charlottesville
Charlottesville, Virginia, 22904
About this study
Official title: Evaluation of Echinacea in a Human Rhinovirus Challenge
The purpose of this study is to determine whether three Echinacea preparations with different chemical compositions are effective for prevention or treatment of the common cold.
Read the detailed description
Echinacea is a widely used herbal remedy for the common cold. Previous clinical trials designed to assess the efficacy of Echinacea for prevention or treatment of the common cold have produced inconsistent results. A variety of different Echinacea products have been used in these clinical trials. Recent studies indicate that different Echinacea preparations have dramatically different phytochemical profiles. The available clinical trial data provide no information about the potential role of the different constituents of Echinacea in common cold prevention or treatment. Our hypothesis is that the variation in reported clinical effectiveness may be due to differences in the phytochemical profile of the Echinacea preparations used. This study will address the following specific aims: 1) Evaluate the effectiveness of chemically defined extracts of E. angustifolia root which contain alkamides, echinacoside or polysaccharidelglycoprotein for common cold prevention or treatment; 2) Assess the correlation between specific Echinacea metabolites in serum and nasal secretions and efficacy for prevention and treatment of colds; and 3) Determine the effect of different Echinacea preparations on the host response to rhinovirus infection.
- Conditions
- Common Cold
- Being tested
- Echinacea
- Keywords
- common cold, Echinacea
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchinaceaDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2002 (estimated)
- Study startSep 2001
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Common ColdStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Ronald B. Turner, MD, Principal investigator, University of Virginia School of MedicineJ. David Gangemi, PhD, Clemson UniversityRudolf Bauer, PhD, Karl-Franzens-Universitaet Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00032500
- Sponsor's protocol ID
- R01AT001146-01
- Status last verified
- Jul 2006
- First submitted
- 22 Mar 2002
- Last updated
- 18 Aug 2006
- Results posted
- No
Publications
Turner RB, Bauer R, Woelkart K, Hulsey TC, Gangemi JD. An evaluation of Echinacea angustifolia in experimental rhinovirus infections. N Engl J Med. 2005 Jul 28;353(4):341-8. doi: 10.1056/NEJMoa044441.
PubMed 16049208
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Echinacea in a Human Rhinovirus Challenge
- ClinicalTrials.gov ID
- NCT00032500
- Acronym / sponsor ID
- R01AT001146-01
- Conditions
- Common Cold
- Keywords
- common cold, Echinacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Sep 2001
- Study completion
- May 2004
- First posted
- 25 Mar 2002 (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.
The purpose of this study is to determine whether three Echinacea preparations with different chemical compositions are effective for prevention or treatment of the common cold.
Detailed description
Echinacea is a widely used herbal remedy for the common cold. Previous clinical trials designed to assess the efficacy of Echinacea for prevention or treatment of the common cold have produced inconsistent results. A variety of different Echinacea products have been used in these clinical trials. Recent studies indicate that different Echinacea preparations have dramatically different phytochemical profiles. The available clinical trial data provide no information about the potential role of the different constituents of Echinacea in common cold prevention or treatment. Our hypothesis is that the variation in reported clinical effectiveness may be due to differences in the phytochemical profile of the Echinacea preparations used. This study will address the following specific aims: 1) Evaluate the effectiveness of chemically defined extracts of E. angustifolia root which contain alkamides, echinacoside or polysaccharidelglycoprotein for common cold prevention or treatment; 2) Assess the correlation between specific Echinacea metabolites in serum and nasal secretions and efficacy for prevention and treatment of colds; and 3) Determine the effect of different Echinacea preparations on the host response to rhinovirus infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Echinacea | Drug | – |
Primary outcome
Not reported in the source record.
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 18 Aug 2006.
- Results publication: PubMed 16049208Turner RB, Bauer R, Woelkart K, Hulsey TC, Gangemi JD. An evaluation of Echinacea angustifolia in experimental rhinovirus infections. N Engl J Med. 2005 Jul 28;353(4):341-8. doi: 10.1056/NEJMoa044441.
Related trials for Common Cold
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Not yet recruitingObservational study
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Recruiting
Omega-Cold Supplementation With Free Fatty Acids for the Prevention of Respiratory Infections in Adults.
Respiratory Infections
Recruiting
Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"
Acute Rhinitis, Nasal Obstruction
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.
Ronald B. Turner, MD principal investigator
University of Virginia School of Medicine
J. David Gangemi, PhD
Clemson University
Rudolf Bauer, PhD
Karl-Franzens-Universitaet Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Echinacea in people with Common Cold, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00032500, which also lists 1 linked publication.
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 18 Aug 2006.