This is a clinical trial and participants will be divided into two groups. One group will be given active tablets and the other group will be given a placebo tablet as an addition to conventional treatment. Participants will not know to which group they have been allocated. Some details from your doctor’s consultation will also form part of the study.
If you agree to be involved in the study, you will be asked to take one “study tablet” every 12 hours (in total 8 tablets), along with the treatment your Doctor prescribes. You will also be asked to complete a daily diary about your symptoms, your level of pain, and how this is affecting your daily activities. When you have no further symptoms, you will be asked to complete a final questionnaire and return it with your diary to the researchers. The diary should take about 2-3 minutes every day and the final questionnaire should take about 10 minutes to complete.
General Practitioners participating in this study will invite you to this study. Taking part in this study is completely voluntary and you can stop taking part in the study at any time without explanation or prejudice. Choosing not to participate or withdrawing from the study will not affect your future care and treatment in any way.
If you are a patient participating in the study
As with any treatment, there are possible risks. Although you will still be prescribed the usual treatment for swimmer’s ear, there is a possibility that your symptoms may get worse e.g. you may experience increased pain or a fever. If this occurs, you should immediately go back to your GP, or if this GP is unavailable attend another GP or the emergency department of the nearest hospital. Furthermore, you should immediately stop taking the “study tablets”.