InfectionsPhase 4NCT01021995
Echinacea Safety Study
A Phase 4 study testing echinacea in people with Infections, run by A. Vogel AG at 1 site in United Kingdom.
Trial summary
Extracts produced from Echinacea purpurea are traditionally used for the prevention and the acute treatment of influenzal infections like the common cold. The aim of this clinical study is to assess clinical safety and efficacy of a treatment with Echinacea in comparison to placebo. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infections
- What is being tested?
- echinacea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 757 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2009to Apr 2011
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- On average more than 2 cold episodes per year
- Age above 18 years
- Good physical condition
- Signed informed consent
Who cannot join
- Women without appropriate and effective contraception
- Participation in a clinical trial 30 days prior to this trial
- Pregnant or breast feeding women
- Subjects with pre-existing cold symptoms for more than 24h at inclusion
- Concurrent participation in another clinical trial
- Intake of antimicrobial and/or antiviral medications at inclusion
Show all 17Show fewer
- Alcohol and/or drug abuse, narcotic drug addiction before and during trial (more than 50 gr and / or 10 cigarettes per day)
- Psychiatric disorders which may influence the results of the trial,
- epilepsy, suicide attempts
- Planned surgical intervention during the trial.
- Serious chronic diseases which influence the absorption, metabolism and the elimination of the investigational product, especially progressive systemic illnesses like tuberculosis, leukaemia,
- collagen disorders and multiple sclerosis
- Known AIDS, HIV-infections and autoimmune diseases
- Known diabetes mellitus (type 1)
- Corticosteroid-treated asthma
- Atopic and allergic subjects (under medicinal treatment)
- Known allergy to plants of the composite family (Asteraceae)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cardiff School of Biosciences
Cardiff, Wales, CF103AX
About this study
Official title: Safety and Efficacy of Long-term Treatment With Echinaforce® Over 4 Months
Extracts produced from Echinacea purpurea are traditionally used for the prevention and the acute treatment of influenzal infections like the common cold. The aim of this clinical study is to assess clinical safety and efficacy of a treatment with Echinacea in comparison to placebo. 750 healthy subjects with a history of equal or more than 2 cold episodes per year will be recruited during October and November 2009 and will be treated with either Echinacea or placebo over a period of 4 months.
Throughout the study period adverse events (AEs) and adverse drug reactions (AEs with at least a possible causal relation to the treatment) will be recorded.
Common cold related symptoms will be recorded in a daily diary.
- Conditions
- Infections
- Being tested
- echinacea, placebo
- Keywords
- Safety of Echinacea in comparison to placebo
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echinaceaDrug
drops, 0.9 ml, tid for 4 months
placeboDrug
drops, 0.9 ml tid for 4 months
| Study group | Role | What they receive |
|---|---|---|
| echinacea | Experimental | Not described Receives: Drug: echinacea |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Adverse Drug Reactions
Measured: 4 months
Secondary outcomes (1)
efficacy
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionAug 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 757 participants (actual)
Sponsor and investigators
- Lead sponsor
- A. Vogel AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021995
- Sponsor's protocol ID
- 920'134
- Status last verified
- Jun 2011
- First submitted
- 30 Nov 2009
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Long-term Treatment With Echinaforce® Over 4 Months
- ClinicalTrials.gov ID
- NCT01021995
- Acronym / sponsor ID
- 920'134
- Conditions
- Infections
- Keywords
- Safety of Echinacea in comparison to placebo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 757 participants (actual)
- Lead sponsor
- A. Vogel AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 1 Dec 2009 (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.
Extracts produced from Echinacea purpurea are traditionally used for the prevention and the acute treatment of influenzal infections like the common cold. The aim of this clinical study is to assess clinical safety and efficacy of a treatment with Echinacea in comparison to placebo. 750 healthy subjects with a history of equal or more than 2 cold episodes per year will be recruited during October and November 2009 and will be treated with either Echinacea or placebo over a period of 4 months.
Throughout the study period adverse events (AEs) and adverse drug reactions (AEs with at least a possible causal relation to the treatment) will be recorded.
Common cold related symptoms will be recorded in a daily diary.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| echinacea | Experimental | Drug: echinacea |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- On average more than 2 cold episodes per year
- Age above 18 years
- Good physical condition
- Signed informed consent
Key exclusion criteria (17 listed)
- Women without appropriate and effective contraception
- Participation in a clinical trial 30 days prior to this trial
- Pregnant or breast feeding women
- Subjects with pre-existing cold symptoms for more than 24h at inclusion
- Concurrent participation in another clinical trial
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 |
|---|---|---|
| echinaceadrops, 0.9 ml, tid for 4 months | Drug | echinacea |
| placebodrops, 0.9 ml tid for 4 months | Drug | placebo |
Primary outcome
Occurrence of Adverse Drug Reactions
Time frame: 4 months
1 secondary outcome
efficacy
Time frame: 4 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 23 Jul 2014.
Related trials for Infections
RecruitingPhase 1/2
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Lymphoma, Non-Hodgkin Lymphoma
Not yet recruitingPhase 3
Efficacy and Safety of Minocycline Add-on in Patients With Neurosyphilis
Neurosyphilis
RecruitingObservational study
Study of Mycobacterial Infections
Mycobacterium Infections
RecruitingPhase 2
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age
SARS-CoV-2
Active, not recruiting
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Human Papilloma Virus (HPV) Vaccine
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing echinacea in people with Infections, run by A. Vogel AG at 1 site in United Kingdom.
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 17 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 23 Jul 2014. 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 Kingdom. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Occurrence of Adverse Drug Reactions (time frame: 4 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 23 Jul 2014.