Irritable Bowel Syndrome
Conditions
Brief summary
The purpose of this study is to determine whether a daily use of a Kneipp hot cataplasm with caraway oil is effective in the treatment of abdominal pain and complaints caused by Irritable bowel syndrome.
Detailed description
see above.
Interventions
DRUGcaraway oil
essential oil, Carum carvi, 2% dissolved in olive oil, 1 teaspoon with caraway oil used externally as inunction together with a hot cataplasm
DRUGOlive oil
1 teaspoon with caraway oil used externally as inunction together with a hot or cold cataplasm as assigned
Sponsors
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Irritable Bowel Syndrome according to Rom-III * Subtype Diarrhea or Alternating * discomfort or pain \> 1 times a week * discomfort or pain \> 4 on a Visual Analog Scale
Exclusion criteria
* Inflammatory bowel diseases (test results necessary) * Lactose, Fructose Malabsorption (test results necessary) * Celiac Disease * Pregnancy or Breastfeeding * Colectomy or Hemicolectomy \>50cm * Severe metabolic disorders, hormonal disorders, cardiac or respiratory failure, liver or renal diseases * severe depression, psychotic or psychiatric disorders, substance abuse * cancer within the last 5 years * allergy to caraway * acute inflammatory diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Irritable Bowel Syndrome - Symptom Severity Score | at T2 (Day 21) | IBS-SSS (Francis 1997) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of abdominal discomfort/Pain | last week of treatment (days 14-21) | Daily rating of pain intensity on a 100mm Visual analogue scale, pain diary |
| Quality of life | T2 (Day 21) | measured with the EQ-5D |
| Quality of life - ibs specific | T2 (day 21) | measured with the IBS-QOL (Patrick, 1998) |
| Frequency of abdominal discomfort/Pain | last week of treatment (days 14-21) | Diary, daily rating of pain |
| Global improvement | At day 7, 14 and 21 | Question on global improvement: How have your symptomes changed compared to the last week: from much worse to much better on a 7-point scale |
| h-BD2 | T2 (day 21) | h-BD2 laboratory findings |
| Adequate Relief Score | at day 7, 14, 21 | Adequate Relief Score (Mangel, 1998) |
| Depression and Anxiety | T2 (day 21) | HADS questionnaire (Hermann, 1995) |
Countries
Germany
Outcome results
None listed