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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jost Langhorst, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01418053
First received: August 15, 2011
Last updated: October 29, 2013
Last verified: October 2013
  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)


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
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

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

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: October 29, 2013
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 April 16, 2014