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Completed

NCT Number: NCT01418053

The Effect of 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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Naturheilkunde und Integrative Medizin

Essen, 45276, Germany

About this study

see above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

caraway oil

Drug

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

Olive Oil

Drug

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

Primary outcomes

  1. Irritable Bowel Syndrome - Symptom Severity Score

    Time frame: at T2 (Day 21)

    IBS-SSS (Francis 1997)

Secondary outcomes

  1. Frequency of abdominal discomfort/Pain

    Time frame: last week of treatment (days 14-21)

    Diary, daily rating of pain

  2. 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

  3. Quality of life

    Time frame: T2 (Day 21)

    measured with the EQ-5D

  4. Quality of life - ibs specific

    Time frame: T2 (day 21)

    measured with the IBS-QOL (Patrick, 1998)

  5. Depression and Anxiety

    Time frame: T2 (day 21)

    HADS questionnaire (Hermann, 1995)

  6. 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

  7. h-BD2

    Time frame: T2 (day 21)

    h-BD2 laboratory findings

  8. Adequate Relief Score

    Time frame: at day 7, 14, 21

    Adequate Relief Score (Mangel, 1998)

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

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

Acronym: CarO

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 16, 2011
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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