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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01418053
First Posted: August 16, 2011
Last Update Posted: October 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jost Langhorst, Universität Duisburg-Essen
  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
Intervention Model: Crossover Assignment
Masking: None (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 Jost Langhorst, Universität Duisburg-Essen:

Primary Outcome Measures:
  • Irritable Bowel Syndrome - Symptom Severity Score [ Time Frame: at T2 (Day 21) ]
    IBS-SSS (Francis 1997)


Secondary Outcome Measures:
  • Frequency of abdominal discomfort/Pain [ Time Frame: last week of treatment (days 14-21) ]
    Diary, daily rating of pain

  • Intensity of abdominal discomfort/Pain [ Time Frame: last week of treatment (days 14-21) ]
    Daily rating of pain intensity on a 100mm Visual analogue scale, pain diary

  • Quality of life [ Time Frame: T2 (Day 21) ]
    measured with the EQ-5D

  • Quality of life - ibs specific [ Time Frame: T2 (day 21) ]
    measured with the IBS-QOL (Patrick, 1998)

  • Depression and Anxiety [ Time Frame: T2 (day 21) ]
    HADS questionnaire (Hermann, 1995)

  • Global improvement [ Time Frame: 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 [ Time Frame: T2 (day 21) ]
    h-BD2 laboratory findings

  • Adequate Relief Score [ Time Frame: at day 7, 14, 21 ]
    Adequate Relief Score (Mangel, 1998)


Enrollment: 48
Study Start Date: August 2011
Study Completion Date: September 2013
Primary Completion Date: September 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
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
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

Detailed Description:
see above.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418053


Locations
Germany
Klinik für Naturheilkunde und Integrative Medizin
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jost Langhorst, Prof. Dr. med., Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT01418053     History of Changes
Other Study ID Numbers: 11-4627 CarO
First Submitted: August 15, 2011
First Posted: August 16, 2011
Last Update Posted: October 30, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases