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

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: caraway oil; Drug: Olive oil

• Registration Number: NCT01418053
• Lead Sponsor: Universität Duisburg-Essen

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hot Cataplasm with Caraway Oil	caraway oil	-
Hot Cataplasm with Olive oil	Olive oil	-
Cold cataplasm with Olive oil	Olive oil	-

Primary Outcome Measures

Name	Time	Method
Irritable Bowel Syndrome - Symptom Severity Score	at T2 (Day 21)	IBS-SSS (Francis 1997)

Secondary Outcome Measures

Name	Time	Method
Frequency of abdominal discomfort/Pain	last week of treatment (days 14-21)	Diary, daily rating of pain
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)
Depression and Anxiety	T2 (day 21)	HADS questionnaire (Hermann, 1995)
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)

Trial Locations

Locations (1)

Klinik für Naturheilkunde und Integrative Medizin; 🇩🇪 Essen, Germany