irritable bowel syndrome – improvement to the clinical situation by the use of humic acid
- Conditions
- K58Irritable bowel syndrome
- Registration Number
- DRKS00005183
- Lead Sponsor
- WH Pharmawerk Weinböhla GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 46
• 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
• 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Safety:<br>- adverse events <br>- rescue medication according to patient diary<br>- number of patients with premature termination of the trial<br>efficacy: before and after comparison (day 0 and day 28) for<br>- Bristol Stool Form Scale <br>- IBS-QOL for documentation of quality of life<br>- Quality of life (SF-36)<br>- further explorative endpoints<br>