Acute bronchitis Respiratory Acute bronchitis
Conditions
Interventions
2.5 ml EPs® 7630 syrup 3 times/day or 10 drops EPs® 7630 solution 3 times/day for 7 consecutive days
Sponsors
Dr. Willmar Schwabe GmbH & Co KG (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient from 1 year to 5 years old 2. Patient is suffering from symptoms related to acute bronchitis (the patients must have at least two of the three bronchitis-relevant symptoms, i.e. coughing, pulmonary rales at auscultation, and dyspnoea) 3. Patient for whom the legal representatives have given a written informed consent in accordance with the legal requirements 4. Start of symptoms <= 72 hours prior to inclusion into the study
Exclusion criteria
Exclusion criteria: 1. Patient with indication of treatment with antibiotics (e.g. suspected pneumonia) 2. Patient with diagnosed or suspected pneumonia, rhinosinusitis, otitis media, or group A beta-hemolytic streptococcal (GABHS) tonsillo-pharyngitis 3. Patient with suspicion of foreign body aspiration 4. Known or suspected allergic rhinitis or other allergic diseases 5. History of asthma bronchiale or recurrent bronchitis 6. History of heart, renal, or liver diseases and/or immunosuppression 7. Known or suspected congenital anomalies of heart, kidney, liver, or mental disabilities 8. Known or suspected hypersensitivity against EPs® 7630 or other excipients of the investigational products 9. Known or suspected gastro-esophageal reflux disease (GERD) 10. Patient with tendency to bleed, especially nose or gingival bleeding 11. Previous (within the last 6 weeks prior to inclusion into the clinical trial) or concomitant treatment with anti-coagulants 12. Known or suspected gastrointestinal disorders (e.g. inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, disbacteriosis, other disorders associated with diarrhoea) 13. Participation in a further clinical trial at the same time or within the last 4 weeks prior to inclusion into the present study 14. Previous participation in the present clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: 1. Frequency, severity, and nature of adverse events measured throughout the treatment period (7 days of treatment). 2. Changes in vital signs measured at day 7 3. Changes in laboratory values measured at day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient´s health status: 1. Changes in individual respiratory tract infection symptoms related to acute bronchitis as well as the total symptoms score 2. Treatment outcome using the Integrative Medicine Outcomes Score (IMOS) as assessed by the investigator as well as by the legal representatives of the patients 3. Satisfaction with the treatment using the Integrative Medicine Patient Satisfaction Scale (IMPSS) as assessed by the legal representatives of the patients Measured at day 7 | — |
Countries
Germany
Outcome results
None listed