Superiority of Newly Developed Over Basic Echinacea Formulations for the Treatment of Respiratory Tract Infections
Study Details
Study Description
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 |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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%)
|
Outcome Measures
Primary Outcome Measures
- Time to remission from initial episodes [maximally 10 days]
duration until respiratory symptoms are solved
Secondary Outcome Measures
- Time to remission from overall episodes [maximally 10 days]
duration until respiratory symptoms are solved
- Cross-comparison of remissions between formulations [maximally 10 days]
duration until respiratory symptoms are solved
- Development of single respiratory symptoms [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 [maximally 10 days]
Comparison of symptom sum scores between formulations, adapted Jackson Score [0-27, each 0=absent, 3=severe]
- Absence from School/Work [during acute respiratory episodes, 7 days each]
Number of days absent from work or school
- Reduction of viral load in nasopharyngeal samples [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 [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) [At Inclusion visit and day 5 of infection]
Change of blood parameters before (V1) and after treatment (V2)
- Blood safety (creatinin [umol/l]) [At Inclusion visit and day 5 of infection]
Change of blood parameters before (V1) and after treatment (V2)
- Blood safety (ALT [ukat/l]) [At Inclusion visit and day 5 of infection]
Change of blood parameters before (V1) and after treatment (V2)
- Blood safety (AST [ukat/l]) [At Inclusion visit and day 5 of infection]
Change of blood parameters before (V1) and after treatment (V2)
- Blood safety (Bilirubin [umol/l]) [At Inclusion visit and day 5 of infection]
Change of blood parameters before (V1) and after treatment (V2)
- Acceptance of treatment [At end of treatment cycle of 10 days]
Question:"would you use the medicament again?"
- Concomitant medication and -therapy [during acute respiratory episodes of 10 days]
Incidence of concomitant medication and -therapy
- adverse events [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 [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.
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cantonal Hospital St. Gallen | Saint Gallen | Switzerland |
Sponsors and Collaborators
- A. Vogel AG
- Cantonal Hospital of St. Gallen
- Labormedizinisches Zentrum Dr. Risch
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5'000'155