Gastrointestinal disorders, especially stomach problems, are widespread. This prospective, non-interventional, comparative study investigated safety and efficacy of an herbal medical device for the treatment of stomach disorders. For the first 14 days, the patients did not take the test product and started the intake on day 15 for a duration of 14 days. Full data sets of 100 included patients were assessed. Symptoms were assessed by a visual scale weekly (day 1 to day 28) and changes of the overall recognised symptoms on a 3-stage scale in phase II (day 15 to day 21). Over the whole study duration, the patients documented the daily overall symptom severity in a patient’s diary and all adverse events were assessed. During phase I, most of the symptoms remained unchanged. After phase II, the overall mean severity of gastrointestinal disorders as well as the specific symptom severity had improved significantly. The course of symptom severity was significantly different between both phases, in favour of the study product. Additionally, an average of 56% of patients reported a subjectively reduced symptom severity after day 28. The study product has shown a good efficacy and safety profile in the treatment of gastrointestinal disorders.

The authors Julia Chevts and Kirsten Sander declare that they have no conflict of interest. Nicole Schuster is an employee of the manufacturer. The study was sponsored by the manufacturer of the study product.

DRKS00035998

No official funding. Study was sponsored by the manufacturer of the investigational device.

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Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The primary ethics committee of Baden-Wuerttemberg (Landesaerztekammer) gave ethical approval for this study.

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Yes

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