Randomised, placebo-controlled clinical trial on the efficacy of Roleca® juniper 100 mg for dyspeptic digestive complaints such as cramps in the gastrointestinal tract, flatulence and bloating.
This study is testing a treatment called Roleca Juniper 100mg to see if it helps with common digestive problems like tummy cramps, bloating, and trapped wind. Researchers want to find out if it makes people feel better and improves their quality of life, compared to taking a dummy pill (placebo). They will also look at how safe Roleca is and if people can take it easily. Participants will keep a diary to record how they feel, helping scientists understand the treatment's effects. The study aims to gather more information about this existing treatment.
At a glance
What is this study about?
This research is looking into a treatment called Roleca Juniper 100mg, which is a medicine that's already available. The main goal is to understand how well it works for people who often experience uncomfortable digestive symptoms. These symptoms include tummy cramps, feeling bloated (when your stomach feels full and tight), and trapped wind (flatulence).
The study compares Roleca Juniper to a 'placebo', which is a dummy pill that looks just like the real medicine but contains no active ingredients. This is a common and important way to test new treatments, as it helps doctors tell if the improvements people feel are genuinely due to the medicine or just because they expect to feel better. Participants will keep a diary of their symptoms and how they're feeling, which helps the researchers track any changes over time, particularly focusing on how their overall quality of life improves. They are especially interested in seeing if symptoms like tummy discomfort and feeling full improve significantly after taking the treatment.
Beyond just seeing if it works, the study also wants to check how well people tolerate Roleca Juniper and if it's safe to use. This means they'll be looking out for any side effects people might experience. They will also look at how consistently people take their medication as prescribed. In addition, an interesting part of the study involves looking at the 'gut microbiome' – the mix of bacteria in your tummy – both before and during treatment. This could give more clues about how the treatment works.
Key takeaways
- The study is testing Roleca Juniper for common tummy problems like cramps, bloating, and gas.
- It compares Roleca to a dummy pill to see if it really helps.
- Researchers are looking at how symptoms improve and how peoples' quality of life changes.
- They will also check how safe Roleca is and how well people tolerate it.
- The study is for adults aged 18 and over, of any gender.
Who may be eligible?
To take part in this study, you need to be an adult, aged 18 or older. There is no upper age limit, so people of all adult ages can be considered.
Both men and women are welcome to participate. The study is open to anyone who experiences the digestive symptoms they are studying, which include tummy cramps, bloating, and flatulence.
However, it's really important to remember that this is just a quick guide. The research team will have a full list of things they need to check to make sure the study is right for you and that you're right for the study. For example, they'll need to know about any other health conditions you have or any other medicines you take.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you experience tummy cramps, bloating, or trapped wind?
- Are you willing to keep a daily diary of your symptoms and medication?
- Are you able to attend planned appointments for check-ups?
What does participation involve?
If you decide to take part in this study, you would be asked to take either the study medication (Roleca Juniper 100mg) or a dummy pill (placebo) for a set period. You wouldn't know which one you are taking. You would need to keep a detailed diary where you record your digestive symptoms, how you're feeling generally, any side effects, and when you take your medication.
The study involves completing entries in this diary regularly. You would have appointments where your progress is checked – one before you start taking the medicine (V1), and another after you've finished the treatment period (V3). During these appointments, the researchers will talk to you about your symptoms and measure how your quality of life related to your digestion has changed. The total duration of your involvement in the study would be from your first visit until the last check-up after treatment.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What are 'dyspeptic digestive complaints'?
These are common tummy troubles like cramps, bloating, and trapped wind (flatulence).
What is a 'placebo'?
A placebo is a dummy pill that looks like the real medicine but doesn't have any active ingredients. It helps researchers see if the real medicine is effective.
What is the 'Nepean Dyspepsia Index'?
This is a special questionnaire that helps measure how digestive symptoms affect a person's quality of life.
What is 'Phase IV' in clinical trials?
This means the treatment is already approved but researchers are gathering more information about its long-term effects, benefits, and safety in a larger group of people.
Will I know if I'm taking the real medicine or the placebo?
No, this type of study is 'blinded', meaning neither you nor the researchers will know until the study is over. This ensures fair and accurate results.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.