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Trial record 6 of 28 for:    Echinacea

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

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ClinicalTrials.gov Identifier: NCT03812900
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Collaborators:
Cantonal Hospital of St. Gallen
Labormedizinisches Zentrum Dr. Risch
Information provided by (Responsible Party):
Bioforce AG

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Respiratory Tract Infections Drug: Echinacea purpurea alcoholic extract Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Echinacea

Arm Intervention/treatment
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%)




Primary Outcome Measures :
  1. Time to remission from initial episodes [ Time Frame: maximally 10 days ]
    duration until respiratory symptoms are solved


Secondary Outcome Measures :
  1. Time to remission from overall episodes [ Time Frame: maximally 10 days ]
    duration until respiratory symptoms are solved

  2. Cross-comparison of remissions between formulations [ Time Frame: maximally 10 days ]
    duration until respiratory symptoms are solved

  3. 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]

  4. 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]

  5. Absence from School/Work [ Time Frame: during acute respiratory episodes, 7 days each ]
    Number of days absent from work or school

  6. 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

  7. 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.

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. Acceptance of treatment [ Time Frame: At end of treatment cycle of 10 days ]
    Question:"would you use the medicament again?"

  14. Concomitant medication and -therapy [ Time Frame: during acute respiratory episodes of 10 days ]
    Incidence of concomitant medication and -therapy

  15. 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

  16. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812900


Contacts
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Contact: Roland Schoop, MSc ++41 454 62 05 r.schoop@bioforce.ch

Locations
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Switzerland
Cantonal Hospital St. Gallen Recruiting
Saint Gallen, Switzerland
Contact: Werner Albrich, MD    ++41714942653    werner.albrich@kssg.ch   
Sponsors and Collaborators
Bioforce AG
Cantonal Hospital of St. Gallen
Labormedizinisches Zentrum Dr. Risch

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Responsible Party: Bioforce AG
ClinicalTrials.gov Identifier: NCT03812900     History of Changes
Other Study ID Numbers: 5'000'155
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases