on-interventional trial on the postoperative use of bromelain tablets hysan in an ENT setting
- Conditions
- surgeries in ENT, not prespecified
- Registration Number
- DRKS00010112
- Lead Sponsor
- RSAPHARM Arzneimittel GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 102
Inclusion Criteria
Patients = 12 Jahre
- Surgery in ENT setting
- doctor's decision to prescribe bromelain tablets hysan is Independent from decistion to include the Patient into the study
Exclusion Criteria
Due to the non-interventional character of the study, no exclusion criteria are predefined.
Contraindications and interactions as described in SPC must be considered.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy:<br>- Change in clinical symptoms such as pain, oedema, inflammation during the treatment period.<br>- Global judgement of the doctor on the efficacy of the treatment<br>-Reduction in use of analgetics<br>- Continuation of therapy/ planned reapplication of bromelain tablets hysan®<br><br>Safety:<br>incidence of adverse reactions under treatment<br>judgement on tolerability of the treatment
- Secondary Outcome Measures
Name Time Method descriptive Analysis of data, therefore there is no separate considering of Primary and secondary outcomes. All outcomes are listed in section Primary Outcome.