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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

Tracking Information
First Submitted Date  ICMJE September 7, 2018
First Posted Date  ICMJE January 23, 2019
Last Update Posted Date January 23, 2019
Actual Study Start Date  ICMJE November 30, 2018
Estimated Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2019)
Time to remission from initial episodes [ Time Frame: maximally 10 days ]
duration until respiratory symptoms are solved
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2019)
  • Time to remission from overall episodes [ Time Frame: maximally 10 days ]
    duration until respiratory symptoms are solved
  • Cross-comparison of remissions between formulations [ Time Frame: maximally 10 days ]
    duration until respiratory symptoms are solved
  • 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]
  • 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]
  • Absence from School/Work [ Time Frame: during acute respiratory episodes, 7 days each ]
    Number of days absent from work or school
  • 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
  • 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.
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Acceptance of treatment [ Time Frame: At end of treatment cycle of 10 days ]
    Question:"would you use the medicament again?"
  • Concomitant medication and -therapy [ Time Frame: during acute respiratory episodes of 10 days ]
    Incidence of concomitant medication and -therapy
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Superiority of Newly Developed Over Basic Echinacea Formulations for the Treatment of Respiratory Tract Infections
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Respiratory Tract Infections
Intervention  ICMJE Drug: Echinacea purpurea alcoholic extract
Different galenic forms with Echinacea purpurea alcoholic extract from herb and roots (95:5%)
Study Arms  ICMJE
  • Experimental: Formulation A
    Echinacea purpurea alcoholic extract lozenges (novel formulation)
    Intervention: Drug: Echinacea purpurea alcoholic extract
  • Experimental: Formulation B
    Echinacea purpurea alcoholic extract spray (novel formulation)
    Intervention: Drug: Echinacea purpurea alcoholic extract
  • Active Comparator: Formulation C
    Echinacea purpurea alcoholic extract tablet (basic formulation, reference)
    Intervention: Drug: Echinacea purpurea alcoholic extract
  • Active Comparator: Formulation D
    Echinacea purpurea alcoholic extract, drops (basic formulation, reference)
    Intervention: Drug: Echinacea purpurea alcoholic extract
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 22, 2019)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2019
Estimated Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Roland Schoop, MSc ++41 454 62 05 r.schoop@bioforce.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03812900
Other Study ID Numbers  ICMJE 5'000'155
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bioforce AG
Study Sponsor  ICMJE Bioforce AG
Collaborators  ICMJE
  • Cantonal Hospital of St. Gallen
  • Labormedizinisches Zentrum Dr. Risch
Investigators  ICMJE Not Provided
PRS Account Bioforce AG
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP