Irritable Bowel SyndromeCarONCT01418053
The Effect of Hot Cataplasm With Caraway Oil in the Treatment of Irritable Bowel Syndrome
A study testing caraway oil and Olive oil in people with Irritable Bowel Syndrome, run by Universität Duisburg-Essen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- caraway oil and Olive oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- severe depression, psychotic or psychiatric disorders, substance abuse
- cancer within the last 5 years
- allergy to caraway
- acute inflammatory diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
see above.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- caraway oil, Olive oil
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caraway oilDrug
essential oil, Carum carvi, 2% dissolved in olive oil, 1 teaspoon with caraway oil used externally as inunction together with a hot cataplasm
Olive oilDrug
1 teaspoon with caraway oil used externally as inunction together with a hot or cold cataplasm as assigned
| Study group | Role | What they receive |
|---|---|---|
| Hot Cataplasm with Caraway Oil | Experimental | Not described Receives: Drug: caraway oil |
| Hot Cataplasm with Olive oil | Active comparator | Not described Receives: Drug: Olive oil |
| Cold cataplasm with Olive oil | Active comparator | Not described Receives: Drug: Olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritable Bowel Syndrome - Symptom Severity Score
IBS-SSS (Francis 1997)
Measured: at T2 (Day 21)
Secondary outcomes (8)
Frequency of abdominal discomfort/Pain
Diary, daily rating of pain
Measured: last week of treatment (days 14-21)
Intensity of abdominal discomfort/Pain
Daily rating of pain intensity on a 100mm Visual analogue scale, pain diary
Measured: last week of treatment (days 14-21)
Quality of life
measured with the EQ-5D
Measured: T2 (Day 21)
Quality of life - ibs specific
measured with the IBS-QOL (Patrick, 1998)
Measured: T2 (day 21)
Depression and Anxiety
HADS questionnaire (Hermann, 1995)
Measured: T2 (day 21)
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
Measured: At day 7, 14 and 21
h-BD2
h-BD2 laboratory findings
Measured: T2 (day 21)
Adequate Relief Score
Adequate Relief Score (Mangel, 1998)
Measured: at day 7, 14, 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jost Langhorst, Universität Duisburg-Essen
- Investigators
- Jost Langhorst, MD, Prof, Principal investigator, University Duisburg-Essen, Chair of Integrative Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418053
- Sponsor's protocol ID
- 11-4627 CarO
- Acronym
- CarO
- Status last verified
- May 2018
- First submitted
- 15 Aug 2011
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26044145
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Study on the Effect of a Kneipp Hot Cataplasm With Caraway Oil in the Treatment of Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01418053
- Acronym / sponsor ID
- CarO / 11-4627 CarO
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Inflammatory bowel diseases (test results necessary)
- Lactose, Fructose Malabsorption (test results necessary)
- Celiac Disease
- Pregnancy or Breastfeeding
- Colectomy or Hemicolectomy >50cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| caraway oilessential oil, Carum carvi, 2% dissolved in olive oil, 1 teaspoon with caraway oil used externally as inunction together with a hot cataplasm | Drug | Hot Cataplasm with Caraway Oil |
| Olive oil1 teaspoon with caraway oil used externally as inunction together with a hot or cold cataplasm as assigned | Drug | Cold cataplasm with Olive oil, Hot Cataplasm with Olive oil |
Primary outcome
Irritable Bowel Syndrome - Symptom Severity Score
Time frame: at T2 (Day 21)
IBS-SSS (Francis 1997)
8 secondary outcomes
Frequency of abdominal discomfort/Pain
Time frame: last week of treatment (days 14-21)
Intensity of abdominal discomfort/Pain
Time frame: last week of treatment (days 14-21)
Quality of life
Time frame: T2 (Day 21)
Quality of life - ibs specific
Time frame: T2 (day 21)
Depression and Anxiety
Time frame: T2 (day 21)
Global improvement
Time frame: At day 7, 14 and 21
h-BD2
Time frame: T2 (day 21)
Adequate Relief Score
Time frame: at day 7, 14, 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Results publication: PubMed 26044145Lauche 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jost Langhorst, MD, Prof principal investigator
University Duisburg-Essen, Chair of Integrative Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caraway oil and Olive oil in people with Irritable Bowel Syndrome, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irritable Bowel Syndrome - Symptom Severity Score (time frame: at T2 (Day 21)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01418053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.