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

NCT01418053 | Completed

• 1 other identifier: 11-4627 CarO
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Irritable Bowel Syndrome - Symptom Severity Score

  IBS-SSS (Francis 1997)

  at T2 (Day 21)

Secondary Outcomes (8)

• Frequency of abdominal discomfort/Pain

  last week of treatment (days 14-21)

• Intensity of abdominal discomfort/Pain

  last week of treatment (days 14-21)

• Quality of life

  T2 (Day 21)

• Quality of life - ibs specific

  T2 (day 21)

• Depression and Anxiety

  T2 (day 21)

Study Arms (3)

Hot Cataplasm with Caraway Oil

EXPERIMENTAL

Drug: caraway oil

Hot Cataplasm with Olive oil

ACTIVE COMPARATOR

Drug: Olive oil

Cold cataplasm with Olive oil

ACTIVE COMPARATOR

Drug: Olive oil

Interventions

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

Hot Cataplasm with Caraway Oil

Olive oil DRUG

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

Cold cataplasm with Olive oil; Hot Cataplasm with Olive oil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

Study Sites (1)

Klinik für Naturheilkunde und Integrative Medizin

Essen, 45276, Germany

Location

Related Publications (1)

• 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.

  PMID: 26044145 RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

caraway oil; Olive Oil

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jost Langhorst, MD, Prof

  University Duisburg-Essen, Chair of Integrative Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 16, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

DE (1)