The Effect of Hot Cataplasm With Caraway Oil in the Treatment of Irritable Bowel Syndrome (CarO)
This study is currently recruiting participants.
Verified December 2012 by Universität Duisburg-Essen
Sponsor:
Universität Duisburg-Essen
Information provided by (Responsible Party):
Jost Langhorst, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01418053
First received: August 15, 2011
Last updated: December 5, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Irritable Bowel Syndrome |
Drug: caraway oil Drug: Olive oil |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomised Controlled Study on the Effect of a Kneipp Hot Cataplasm With Caraway Oil in the Treatment of Irritable Bowel Syndrome |
Resource links provided by NLM:
Further study details as provided by Universität Duisburg-Essen:
Primary Outcome Measures:
- Irritable Bowel Syndrome - Symptom Severity Score [ Time Frame: at T2 (Day 21) ] [ Designated as safety issue: No ]IBS-SSS (Francis 1997)
Secondary Outcome Measures:
- Frequency of abdominal discomfort/Pain [ Time Frame: last week of treatment (days 14-21) ] [ Designated as safety issue: No ]Diary, daily rating of pain
- Intensity of abdominal discomfort/Pain [ Time Frame: last week of treatment (days 14-21) ] [ Designated as safety issue: No ]Daily rating of pain intensity on a 100mm Visual analogue scale, pain diary
- Quality of life [ Time Frame: T2 (Day 21) ] [ Designated as safety issue: No ]measured with the EQ-5D
- Quality of life - ibs specific [ Time Frame: T2 (day 21) ] [ Designated as safety issue: No ]measured with the IBS-QOL (Patrick, 1998)
- Depression and Anxiety [ Time Frame: T2 (day 21) ] [ Designated as safety issue: No ]HADS questionnaire (Hermann, 1995)
- Global improvement [ Time Frame: At day 7, 14 and 21 ] [ Designated as safety issue: No ]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 [ Time Frame: T2 (day 21) ] [ Designated as safety issue: No ]h-BD2 laboratory findings
- Adequate Relief Score [ Time Frame: at day 7, 14, 21 ] [ Designated as safety issue: No ]Adequate Relief Score (Mangel, 1998)
| Estimated Enrollment: | 48 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Hot Cataplasm with Caraway Oil |
Drug: caraway oil
essential oil, Carum carvi, 2% dissolved in olive oil, 1 teaspoon with caraway oil used externally as inunction together with a hot cataplasm
Other Name: caraway oil
|
| Active Comparator: Hot Cataplasm with Olive oil |
Drug: Olive oil
1 teaspoon with caraway oil used externally as inunction together with a hot or cold cataplasm as assigned
Other Name: Olive oil
|
| Active Comparator: Cold cataplasm with Olive oil |
Drug: Olive oil
1 teaspoon with caraway oil used externally as inunction together with a hot or cold cataplasm as assigned
Other Name: Olive oil
|
Detailed Description:
see above.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418053
Contacts
| Contact: Romy Lauche, Ph.D | 0201-174 ext 25508 | r.lauche@kliniken-essen-mitte.de |
Locations
| Germany | |
| Klinik für Naturheilkunde und Integrative Medizin | Recruiting |
| Essen, Germany, 45276 | |
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
| Principal Investigator: | Jost Langhorst, MD, Prof | University Duisburg-Essen, Chair of Integrative Gastroenterology |
More Information
No publications provided
| Responsible Party: | Jost Langhorst, Prof. Dr. med., Universität Duisburg-Essen |
| ClinicalTrials.gov Identifier: | NCT01418053 History of Changes |
| Other Study ID Numbers: | 11-4627 CarO |
| Study First Received: | August 15, 2011 |
| Last Updated: | December 5, 2012 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Irritable Bowel Syndrome Colonic Diseases, Functional Colonic Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013