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

May 3, 2021 updated by: A. Vogel AG

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
246

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Saint Gallen, Switzerland
        • Cantonal Hospital St. Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 18 years old
  • Signed Informed Consent

Exclusion Criteria:

  • 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
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Formulation A
Echinacea purpurea alcoholic extract lozenges (novel formulation)
Drug: Echinacea purpurea alcoholic extract
Different galenic forms with Echinacea purpurea alcoholic extract from herb and roots (95:5%)
Experimental: Formulation B
Echinacea purpurea alcoholic extract spray (novel formulation)
Drug: Echinacea purpurea alcoholic extract
Different galenic forms with Echinacea purpurea alcoholic extract from herb and roots (95:5%)
Active Comparator: Formulation C
Echinacea purpurea alcoholic extract tablet (basic formulation, reference)
Drug: Echinacea purpurea alcoholic extract
Different galenic forms with Echinacea purpurea alcoholic extract from herb and roots (95:5%)
Active Comparator: Formulation D
Echinacea purpurea alcoholic extract, drops (basic formulation, reference)
Drug: Echinacea purpurea alcoholic extract
Different galenic forms with Echinacea purpurea alcoholic extract from herb and roots (95:5%)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to remission from initial episodes
Time Frame: maximally 10 days
duration until respiratory symptoms are solved
maximally 10 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to remission from overall episodes
Time Frame: maximally 10 days
duration until respiratory symptoms are solved
maximally 10 days
Cross-comparison of remissions between formulations
Time Frame: maximally 10 days
duration until respiratory symptoms are solved
maximally 10 days
Development of single respiratory symptoms
Time Frame: maximally 10 days
Comparison of respiratory symptom scores between formulations, adapted Jackson Score [0-3, 0=absent, 3=severe]
maximally 10 days
Development of respiratory symptom sum score
Time Frame: maximally 10 days
Comparison of symptom sum scores between formulations, adapted Jackson Score [0-27, each 0=absent, 3=severe]
maximally 10 days
Absence from School/Work
Time Frame: during acute respiratory episodes, 7 days each
Number of days absent from work or school
during acute respiratory episodes, 7 days each
Reduction of viral load in nasopharyngeal samples
Time Frame: day 1, day 5, day 9
Comparison of virus titer at day 5 and 9 i.c. to day 1
day 1, day 5, day 9
Subjective assessment of efficacy by patient
Time Frame: At end of treatment cycle of 10 days
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.
At end of treatment cycle of 10 days
Blood safety (red and white cell count)
Time Frame: At Inclusion visit and day 5 of infection
Change of blood parameters before (V1) and after treatment (V2)
At Inclusion visit and day 5 of infection
Blood safety (creatinin [umol/l])
Time Frame: At Inclusion visit and day 5 of infection
Change of blood parameters before (V1) and after treatment (V2)
At Inclusion visit and day 5 of infection
Blood safety (ALT [ukat/l])
Time Frame: At Inclusion visit and day 5 of infection
Change of blood parameters before (V1) and after treatment (V2)
At Inclusion visit and day 5 of infection
Blood safety (AST [ukat/l])
Time Frame: At Inclusion visit and day 5 of infection
Change of blood parameters before (V1) and after treatment (V2)
At Inclusion visit and day 5 of infection
Blood safety (Bilirubin [umol/l])
Time Frame: At Inclusion visit and day 5 of infection
Change of blood parameters before (V1) and after treatment (V2)
At Inclusion visit and day 5 of infection
Acceptance of treatment
Time Frame: At end of treatment cycle of 10 days
Question:"would you use the medicament again?"
At end of treatment cycle of 10 days
Concomitant medication and -therapy
Time Frame: during acute respiratory episodes of 10 days
Incidence of concomitant medication and -therapy
during acute respiratory episodes of 10 days
adverse events
Time Frame: during acute respiratory episodes, from day 1 until follow up at day 17 - 21
occurrence of adverse events during treatment with Echinacea
during acute respiratory episodes, from day 1 until follow up at day 17 - 21
Subjective assessment of tolerability by patient
Time Frame: At day 10 of every treatment cycle
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.
At day 10 of every treatment cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
A. Vogel AG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cantonal Hospital of St. Gallen
Labormedizinisches Zentrum Dr. Risch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 5, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 7, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5'000'155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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