Evaluation of safety and tolerability of Pelargonium sidoides extract EPs® 7630 in children (1 to 5 years old) suffering from acute bronchitis

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 600

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety:<br>1. Frequency, severity, and nature of adverse events measured throughout the treatment period (7 days of treatment). <br>2. Changes in vital signs measured at day 7<br>3. Changes in laboratory values measured at day 7

Secondary Outcome Measures

Name	Time	Method
Patient´s health status:<br>1. Changes in individual respiratory tract infection symptoms related to acute bronchitis as well as the total symptoms score<br>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<br>3. Satisfaction with the treatment using the Integrative Medicine Patient Satisfaction Scale (IMPSS) as assessed by the legal representatives of the patients<br><br>Measured at day 7

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