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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014