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

Irritable Bowel Syndrome Clinical Trial

— CarO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418053
• Other study ID #: 11-4627 CarO
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: September 2013

Study information

• Verified date: May 2018
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

see above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Germany	Klinik für Naturheilkunde und Integrative Medizin	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Lauche R, Janzen A, Lüdtke 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Irritable Bowel Syndrome - Symptom Severity Score	IBS-SSS (Francis 1997)	at T2 (Day 21)
Secondary	Frequency of abdominal discomfort/Pain	Diary, daily rating of pain	last week of treatment (days 14-21)
Secondary	Intensity of abdominal discomfort/Pain	Daily rating of pain intensity on a 100mm Visual analogue scale, pain diary	last week of treatment (days 14-21)
Secondary	Quality of life	measured with the EQ-5D	T2 (Day 21)
Secondary	Quality of life - ibs specific	measured with the IBS-QOL (Patrick, 1998)	T2 (day 21)
Secondary	Depression and Anxiety	HADS questionnaire (Hermann, 1995)	T2 (day 21)
Secondary	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	At day 7, 14 and 21
Secondary	h-BD2	h-BD2 laboratory findings	T2 (day 21)
Secondary	Adequate Relief Score	Adequate Relief Score (Mangel, 1998)	at day 7, 14, 21