Various manifestations of gastrointestinal symptoms
Conditions
Interventions
Group 1: Phase 1: No Retterspitz Innerlich® suspension (14 days)
Phase 2: Regular intake of the Retterspitz Innerlich® suspension (14 days)
Sponsors
Retterspitz GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Patients with gastrointestinal complaints that did not require long-term treatment and in whom at least one of the following symptoms occurred from time to time were included: - Heartburn - Irritable stomach - Hyperacidity of the stomach/underacidity of the stomach - Feeling of fullness - Flatulence - Stomach pain
Exclusion criteria
Exclusion criteria: - Patients with known renal insufficiency with renal dialysis - Age 85 - Allergy or intolerance to one or more of the ingredients used - Pregnancy and breastfeeding - Inability to adequately participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| During the 28-day study period, a total of 5 visits were conducted. At each visit, both the severity of individual symptoms and the overall burden were assessed using a 6-stage visual scale (0=no, 1=mild, 2=moderate, 3=strong, 4=very strong, 5=unbelievably strong). Additionally, in Phase II, patients assessed the change of the overall burden using a 3-stage scale (0=improved, 1=unchanged, 2=worsened). Furthermore, patients documented the intensity of symptoms in a daily patient diary using the 6-stage visual scale, which was identical to the scale used during the visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Daily intake of the study product (phase 1), medication, regularity of bowel movements, side effects/adverse events/serious adverse events during the entire study period of 28 days. | — |
Countries
Germany
Contacts
Public ContactJulia Chevts
Siteworks Zentrum für klinische Studien Karlsruhe
Outcome results
None listed