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

Primary Purpose

Irritable Bowel Syndrome

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

caraway oil

Olive oil

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Klinik für Naturheilkunde und Integrative Medizin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Hot Cataplasm with Caraway Oil

Hot Cataplasm with Olive oil

Cold cataplasm with Olive oil

Arm Description

Outcomes

Primary Outcome Measures

Irritable Bowel Syndrome - Symptom Severity Score

IBS-SSS (Francis 1997)

Secondary Outcome Measures

Frequency of abdominal discomfort/Pain

Diary, daily rating of pain

Intensity of abdominal discomfort/Pain

Daily rating of pain intensity on a 100mm Visual analogue scale, pain diary

Quality of life

measured with the EQ-5D

Quality of life - ibs specific

measured with the IBS-QOL (Patrick, 1998)

Depression and Anxiety

HADS questionnaire (Hermann, 1995)

Global improvement

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

h-BD2 laboratory findings

Adequate Relief Score

Adequate Relief Score (Mangel, 1998)

Full Information

NCT ID

NCT01418053

First Posted

August 15, 2011

Last Updated

May 4, 2018

Sponsor

Universität Duisburg-Essen

1. Study Identification

Unique Protocol Identification Number

NCT01418053

Brief Title

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

Acronym

CarO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universität Duisburg-Essen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

see above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hot Cataplasm with Caraway Oil

Arm Type

Experimental

Arm Title

Hot Cataplasm with Olive oil

Arm Type

Active Comparator

Arm Title

Cold cataplasm with Olive oil

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

caraway oil

Intervention Description

essential oil, Carum carvi, 2% dissolved in olive oil, 1 teaspoon with caraway oil used externally as inunction together with a hot cataplasm

Intervention Type

Drug

Intervention Name(s)

Olive oil

Intervention Description

1 teaspoon with caraway oil used externally as inunction together with a hot or cold cataplasm as assigned

Primary Outcome Measure Information:

Title

Irritable Bowel Syndrome - Symptom Severity Score

Description

IBS-SSS (Francis 1997)

Time Frame

at T2 (Day 21)

Secondary Outcome Measure Information:

Title

Frequency of abdominal discomfort/Pain

Description

Diary, daily rating of pain

Time Frame

last week of treatment (days 14-21)

Title

Intensity of abdominal discomfort/Pain

Description

Daily rating of pain intensity on a 100mm Visual analogue scale, pain diary

Time Frame

last week of treatment (days 14-21)

Title

Quality of life

Description

measured with the EQ-5D

Time Frame

T2 (Day 21)

Title

Quality of life - ibs specific

Description

measured with the IBS-QOL (Patrick, 1998)

Time Frame

T2 (day 21)

Title

Depression and Anxiety

Description

HADS questionnaire (Hermann, 1995)

Time Frame

T2 (day 21)

Title

Global improvement

Description

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

Time Frame

At day 7, 14 and 21

Title

h-BD2

Description

h-BD2 laboratory findings

Time Frame

T2 (day 21)

Title

Adequate Relief Score

Description

Adequate Relief Score (Mangel, 1998)

Time Frame

at day 7, 14, 21

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jost Langhorst, MD, Prof

Organizational Affiliation

University Duisburg-Essen, Chair of Integrative Gastroenterology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinik für Naturheilkunde und Integrative Medizin

City

Essen

ZIP/Postal Code

45276

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

26044145

Citation

Lauche R, Janzen A, Ludtke R, Cramer H, Dobos G, Langhorst J. Efficacy of Caraway Oil Poultices in Treating Irritable Bowel Syndrome--A Randomized Controlled Cross-Over Trial. Digestion. 2015;92(1):22-31. doi: 10.1159/000398790. Epub 2015 Jun 5.

Results Reference

result

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

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