K58
Conditions
Interventions
Group 1: Verum (natural humic acid - Activomin®): intake of capsules orally (400mg per capsule) over 28 days (day 1-10: 3x2 capsules daily, day 11-28: 3x1 capsule daily)
Group 2: placebo (rice flour c
Sponsors
WH Pharmawerk Weinböhla GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • irritable bowel syndrome - diarrhea-predominant (RDS-D) --> according to ROM III criteria (diarrhea / pain) • male and female patients = 18 years • patients, who are willing and able to realise the study visits (e.g. no planned holidays) • patients, who are willing and able to complete the patient diary • last to weeks (screening phase) at least two times complaints (pain, discomfort) per week • willing to forgo medications of the forbidden medication list • Written informed consent
Exclusion criteria
Exclusion criteria: • irritable bowel syndrome - obstipation-predominant (RDS-O) • diagnosed, inflammatory bowel disease, as Morbus Crohn, Colitis ulcerosa, chronic inflammatory bowel disease • clinical reference to colon cancer (colonoscopy without pathological findings from the last 5 years for patient > 55 years) • clinical reference to an acute infection • history of known chronic gastritis or inflammatory bowel diseases • history of known coeliac • history of known lactose intolerance • patients with serious diseases in connection with vital medications • naturopathic measures regarding irritable bowel syndrome during the last 6 months before screening • current regular intake of medications influencing motility • addiction • history of known hypersensitivity compared to the substances / medical product • participation in other interventional trials during the last 4 weeks before screening • knowing pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of IBS-Scores (Irritable Bowel Syndrome-Score, Francis 1997) and therefore the improvement of the subject state while having gastrointestinal dysfunctions on day 28 compared to day 0 (Baseline) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: - adverse events - rescue medication according to patient diary - number of patients with premature termination of the trial efficacy: before and after comparison (day 0 and day 28) for - Bristol Stool Form Scale - IBS-QOL for documentation of quality of life - Quality of life (SF-36) - further explorative endpoints | — |
Countries
Austria, Germany
Contacts
Public ContactIngolf Schiefke
Gastroenterologie und Hepatologie am Johannisplatz Dres. Kuchta, Wegner & Prof. Schiefke
Outcome results
None listed