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

May 4, 2018 updated by: Jost Langhorst, Universität Duisburg-Essen

Randomised Controlled Study on the Effect of a Kneipp Hot Cataplasm With Caraway Oil in the Treatment of Irritable Bowel Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

see above.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Essen, Germany, 45276
        • Klinik für Naturheilkunde und Integrative Medizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Irritable Bowel Syndrome - Symptom Severity Score
Time Frame: at T2 (Day 21)
IBS-SSS (Francis 1997)
at T2 (Day 21)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of abdominal discomfort/Pain
Time Frame: last week of treatment (days 14-21)
Diary, daily rating of pain
last week of treatment (days 14-21)
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
last week of treatment (days 14-21)
Quality of life
Time Frame: T2 (Day 21)
measured with the EQ-5D
T2 (Day 21)
Quality of life - ibs specific
Time Frame: T2 (day 21)
measured with the IBS-QOL (Patrick, 1998)
T2 (day 21)
Depression and Anxiety
Time Frame: T2 (day 21)
HADS questionnaire (Hermann, 1995)
T2 (day 21)
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
At day 7, 14 and 21
h-BD2
Time Frame: T2 (day 21)
h-BD2 laboratory findings
T2 (day 21)
Adequate Relief Score
Time Frame: at day 7, 14, 21
Adequate Relief Score (Mangel, 1998)
at day 7, 14, 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universität Duisburg-Essen

Investigators

  • Principal Investigator: Jost Langhorst, MD, Prof, University Duisburg-Essen, Chair of Integrative Gastroenterology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

August 15, 2011

First Submitted That Met QC Criteria

August 15, 2011

First Posted (ESTIMATE)

August 16, 2011

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-4627 CarO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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