Many Locations
Multiple Locations, Germany
NCT Number: NCT04993989
Researchers want to learn more about the day-to-day use of Iberogast in people who have functional and motility-related gastrointestinal (stomach and bowel) diseases.
Functional and motility-related stomach and bowel diseases are conditions in which the functionality of the gut, mainly the gut muscles or the gut/brain axis is disturbed. Functional and motility related stomach and bowel diseases cause symptoms like heartburn, cramps and u pain of the upper and middle part of the belly, also known as functional dyspepsia (FD), and irritable bowel syndrome (IBS). IBS affects predominantly the lower digestive system and causes symptoms like pain of the belly, cramps, bloating, diarrhea, and constipation.
In this study, the researchers want to learn more about Iberogast, a plant-based treatment. Iberogast is available to treat stomach and bowel diseases such as FD and IBS.
Earlier studies with Iberogast have shown how well it works and how it affects the body. But, little is known about the day-to-day use of Iberogast and how satisfied patients are who take it. So in this study, the researchers want to learn more about Iberogast including:
* how well it works in day-to-day use * how it affects the body, also referred to as tolerability * how it is used day-to-day * how safe it is * how satisfied patients are who take it
To answer these questions, the researchers will collect information from pharmacies in Germany. Patients who get Iberogast from these pharmacies to help treat their gastrointestinal disease will complete a questionnaire before, during and after taking Iberogast. The researchers will use the results from the questionnaires to learn more about:
* the disease details of the patients who are taking Iberogast * the patients' symptoms while taking Iberogast * if the patients' symptoms change after taking Iberogast * how satisfied patients are with Iberogast * if the patients had adverse events
An adverse event is any medical problem that a participant has during a study.
This study will include patients in Germany who:
* have functional stomach and bowel symptoms or disorders like FD or IBS * take Iberogast to treat symptoms of their stomach and bowel disease * are able to complete the questionnaire
There will be no required tests or visits with a study doctor in this study. No treatments will be given as part of this study. The researchers will review information collected from patients who have decided for their own or by recommendation of their doctors or pharmacist to take Iberogast. The researchers will collect the results from the patient questionnaires from November 2017 to March 2018.
Looking for future studies?
Notify Me3 year and older
All sexes
Observational
Multiple Locations, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Survey without any intervention assigned in the study.
Time frame: At baseline
Patients answered how quickly a significant improvement in their gastrointestinal symptoms was felt after taking Iberogast.
Time frame: 7 days
Patients assessed the improvement in symptoms/concomitant complaints on an 5 -point Likert scale from 0=no improvement, 1=mild improvement, 2=moderate improvement, 3=good improvement, to 4=very good improvement.
Time frame: 7 days
Patients indicated the respective medication they used/ consumed earlier for their complaints on an 3 -point rating scale as "better", "same" and "poorer".
Time frame: 7 days
Patients assessed tolerability with Iberogast on 5-point Likert scale as "very good", "good", "medium", "poor", and "very poor''.
Time frame: At baseline
Patients answered why Iberogast was chosen and what was the source of awareness of the product.
Time frame: 7 days
Time frame: 7 days
Patients assess their satisfaction with Iberogast on 5 point Likert scale as "very satisfied", "satisfied", "neither satisfied nor unsatisfied", "unsatisfied", and "very unsatisfied.
Time frame: At baseline
Age and sex.
Time frame: At baseline
Functional dyspepsia (FD) and irritable bowel syndrome (IBS) or both.
Bayer
Industry
Pharmacy-based Study on the Effectiveness, Tolerability, Usage Behavior and User Satisfaction of Iberogast® in Functional and Motility-related Gastrointestinal Diseases, Preferably Irritable Bowel Syndrome.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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