AzTrials
AzTrials

Respiratory Tract InfectionsPhase 2/3NCT03812900

Superiority of Newly Developed Over Basic Echinacea Formulations for the Treatment of Respiratory Tract Infections

A Phase 2/3 study testing Echinacea purpurea alcoholic extract in people with Respiratory Tract Infections, run by A. Vogel AG at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a comparative, conceptual, randomized clinical study to investigate newly developed over basic Echinacea formulations for the treatment of acute symptoms of respiratory tract infections. 400 adults will be recruited, of which approximately 300 will develop a common cold or a influenza-like infection. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Respiratory Tract Infections
What is being tested?
Echinacea purpurea alcoholic extract
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
1 siteSwitzerland
Study dates
27 Nov 2018to 7 Jun 2019
Phase
Phase 2/3
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • At least 18 years old
  • Signed Informed Consent

Who cannot join

  • Younger than 18 years
  • Participation in another clinical study in the past 30 days
  • Permanent intake of antimicrobial, antiviral, immune suppressive substances
  • Surgical intervention in the 3 months prior to inclusion or planned surgery during period of observation
  • Known diabetes melitus
  • Known and treated atopy or asthma bronchiale
Show all 14Show fewer
  • Cystic fibrosis, bronchopulmonale dysplasia, COPD
  • Known diseases of the immune system, degenerative illnesses (e.g. auto-immune disorders like AIDS or leukemia, myeloma)
  • Known metabolic or resorptive disorders
  • Known chronic liver diseases (chronic hepatitis, liver cirrhosis)
  • Known chronic kidney insufficiency
  • Serious health issues (reduced health status, autoimmune illness, tumorous illness)
  • Known allergy to plants of compositae family (camomille, dandelion) or to any substances of the investigational product
  • At inclusion known pregnancy or planned pregnancy during period of investigation (required: active contraception for women of childbearing year)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Cantonal Hospital St. Gallen

    Sankt Gallen

Other trials in Switzerland

About this study

Official title: Comparative, Conceptual, Randomized Clinical Study to Investigate Superiority of Newly Developed Over Basic Echinacea Formulations for the Treatment of Acute Symptoms of Respiratory Tract Infections

This is a comparative, conceptual, randomized clinical study to investigate newly developed over basic Echinacea formulations for the treatment of acute symptoms of respiratory tract infections. 400 adults will be recruited, of which approximately 300 will develop a common cold or a influenza-like infection. Two newly developed and two existing Echinacea formulations (solid/liquid) will be randomly dispensed at inclusion for treatment of maximal 3 infections. Treatment starts at first signs of infection and lasts for a maximum of 10 days or until symptom resolution. Nasopharynx samples will be collected for analysis of common viral respiratory agents throughout treatment. Safety and efficacy variables will be assessed.

Read the detailed description

The monocentre trial compares two newly developed pharmaceutical forms of Echinacea (extract from Echinacea purpurea Herba and Radix; lozenges or spray) with two basic and authorised pharmaceutical forms (tablets or drops; comparator groups) for the treatment of acute symptoms of the common cold and/or influenza-like illness (ILI) in adults. Trial subjects are preventatively screened and included in the study (n = 400). If they show acute symptoms of a common cold or ILI during the study period, they are instructed to call the study centre to have confirmed the indication for treatment and begin with the treatment, they are randomized to (1:1:1:1 randomization into one of four groups). The primary endpoint is the time until remission of respiratory symptoms with the new pharmaceutical forms compared to the basic forms during the first episode. Secondary endpoints include remission of all treated episodes (max. 3 episodes), remission times comparison between different pharmaceutical forms (e.g. lozenges vs. spray, lozenges vs. drops etc), reduction of viral load on day 5 and 9 compared to day 1 of treatment (nasopharyngeal swabs), differences in safety (blood parameters before and during treatment), differences in number of adverse events, tolerance and efficacy assessed by the patients.

Being tested
Echinacea purpurea alcoholic extract
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.

  • Echinacea purpurea alcoholic extractDrug

    Different galenic forms with Echinacea purpurea alcoholic extract from herb and roots (95:5%)

Study groups in NCT03812900
Study groupRoleWhat they receive
Formulation AExperimentalEchinacea purpurea alcoholic extract lozenges (novel formulation)
Receives: Drug: Echinacea purpurea alcoholic extract
Formulation BExperimentalEchinacea purpurea alcoholic extract spray (novel formulation)
Receives: Drug: Echinacea purpurea alcoholic extract
Formulation CActive comparatorEchinacea purpurea alcoholic extract tablet (basic formulation, reference)
Receives: Drug: Echinacea purpurea alcoholic extract
Formulation DActive comparatorEchinacea purpurea alcoholic extract, drops (basic formulation, reference)
Receives: Drug: Echinacea purpurea alcoholic extract

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to remission from initial episodes

    duration until respiratory symptoms are solved

    Measured: maximally 10 days

Secondary outcomes (16)

  1. Time to remission from overall episodes

    duration until respiratory symptoms are solved

    Measured: maximally 10 days

  2. Cross-comparison of remissions between formulations

    duration until respiratory symptoms are solved

    Measured: maximally 10 days

  3. Development of single respiratory symptoms

    Comparison of respiratory symptom scores between formulations, adapted Jackson Score [0-3, 0=absent, 3=severe]

    Measured: maximally 10 days

  4. Development of respiratory symptom sum score

    Comparison of symptom sum scores between formulations, adapted Jackson Score [0-27, each 0=absent, 3=severe]

    Measured: maximally 10 days

  5. Absence from School/Work

    Number of days absent from work or school

    Measured: during acute respiratory episodes, 7 days each

  6. Reduction of viral load in nasopharyngeal samples

    Comparison of virus titer at day 5 and 9 i.c. to day 1

    Measured: day 1, day 5, day 9

  7. Subjective assessment of efficacy by patient

    Comparisons of subjective efficacy assessments between patients [0=poor; 1=moderate; 2=good; 3=very good]. Inofficial scale and and global method of assessing patients satisfaction re efficacy.

    Measured: At end of treatment cycle of 10 days

  8. Blood safety (red and white cell count)

    Change of blood parameters before (V1) and after treatment (V2)

    Measured: At Inclusion visit and day 5 of infection

  9. Blood safety (creatinin [umol/l])

    Change of blood parameters before (V1) and after treatment (V2)

    Measured: At Inclusion visit and day 5 of infection

  10. Blood safety (ALT [ukat/l])

    Change of blood parameters before (V1) and after treatment (V2)

    Measured: At Inclusion visit and day 5 of infection

  11. Blood safety (AST [ukat/l])

    Change of blood parameters before (V1) and after treatment (V2)

    Measured: At Inclusion visit and day 5 of infection

  12. Blood safety (Bilirubin [umol/l])

    Change of blood parameters before (V1) and after treatment (V2)

    Measured: At Inclusion visit and day 5 of infection

  13. Acceptance of treatment

    Question:"would you use the medicament again?"

    Measured: At end of treatment cycle of 10 days

  14. Concomitant medication and -therapy

    Incidence of concomitant medication and -therapy

    Measured: during acute respiratory episodes of 10 days

  15. adverse events

    occurrence of adverse events during treatment with Echinacea

    Measured: during acute respiratory episodes, from day 1 until follow up at day 17 - 21

  16. Subjective assessment of tolerability by patient

    Comparisons of subjective tolerability assessments between patients [0=poor; 1=moderate; 2=good; 3=very good]. Inofficial scale and and global method of assessing patients satisfaction re tolerability.

    Measured: At day 10 of every treatment cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2019
  2. Study start27 Nov 2018
  3. Primary completion5 Jun 2019
  4. Study completion7 Jun 2019

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03812900
Sponsor's protocol ID
5'000'155
Status last verified
Apr 2021
First submitted
7 Sep 2018
Last updated
4 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sumer J, Keckeis K, Scanferla G, Frischknecht M, Notter J, Steffen A, Kohler P, Schmid P, Roth B, Wissel K, Vernazza P, Klein P, Schoop R, Albrich WC. Novel Echinacea formulations for the treatment of acute respiratory tract infections in adults-A randomized blinded controlled trial. Front Med (Lausanne). 2023 Apr 17;10:948787. doi: 10.3389/fmed.2023.948787. eCollection 2023.

    PubMed 37138742

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Echinacea purpurea alcoholic extract in people with Respiratory Tract Infections, run by A. Vogel AG at 1 site in Switzerland.

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 2 inclusion and 14 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 4 May 2021. 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 Switzerland. 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 combined 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.

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?

Time to remission from initial episodes (time frame: maximally 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03812900, 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 4 May 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in