The Effect of Hot Cataplasm With Caraway Oil in the Treatment of Irritable Bowel Syndrome

Study Overview
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Brief Summary
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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
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see above.

Official Title
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Randomised Controlled Study on the Effect of a Kneipp Hot Cataplasm With Caraway Oil in the Treatment of Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: caraway oil
* Drug: Olive oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hot Cataplasm with Caraway Oil<br> | Drug: caraway oil<br>* essential oil, Carum carvi, 2% dissolved in olive oil, 1 teaspoon with caraway oil used externally as inunction together with a hot cataplasm<br>|
| Active Comparator: Hot Cataplasm with Olive oil<br> | Drug: Olive oil<br>* 1 teaspoon with caraway oil used externally as inunction together with a hot or cold cataplasm as assigned<br>|
| Active Comparator: Cold cataplasm with Olive oil<br> | Drug: Olive oil<br>* 1 teaspoon with caraway oil used externally as inunction together with a hot or cold cataplasm as assigned<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritable Bowel Syndrome - Symptom Severity Score | IBS-SSS (Francis 1997) | at T2 (Day 21) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of abdominal discomfort/Pain | Diary, daily rating of pain | last week of treatment (days 14-21) | 
| Intensity of abdominal discomfort/Pain | Daily rating of pain intensity on a 100mm Visual analogue scale, pain diary | last week of treatment (days 14-21) | 
| Quality of life | measured with the EQ-5D | T2 (Day 21) | 
| Quality of life - ibs specific | measured with the IBS-QOL (Patrick, 1998) | T2 (day 21) | 
| Depression and Anxiety | HADS questionnaire (Hermann, 1995) | T2 (day 21) | 
| Global improvement | 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 | At day 7, 14 and 21 | 
| h-BD2 | h-BD2 laboratory findings | T2 (day 21) | 
| Adequate Relief Score | Adequate Relief Score (Mangel, 1998) | at day 7, 14, 21 |