Irritable Bowel SyndromeAHIBNCT01418066
Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome
A study testing Ayurvedic Herbs in people with Irritable Bowel Syndrome, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
In the present study the investigators are trying to evaluate the effect of Murraya koenigii leaves, Punica granatum and Curcuma which is administered to the patients in a combined form as tea. This study will help to evaluate the effect of these preparations scientifically in improving the IBS symptoms. 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?
- Ayurvedic Herbs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Dec 2012
- 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
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- 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.
Germany1 site
Klinik für Naturheilkunde und Integrative Medizin
Essen, North Rhine-Westphalia, 45276
About this study
Official title: Feasibility and Safety of Ayurvedic Herbs in Diarrhoea-predominant Irritable Bowel Syndrome
In the present study the investigators are trying to evaluate the effect of Murraya koenigii leaves, Punica granatum and Curcuma which is administered to the patients in a combined form as tea. This study will help to evaluate the effect of these preparations scientifically in improving the IBS symptoms.
Read the detailed description
see above
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Ayurvedic Herbs, Placebo tea
- 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.
Ayurvedic HerbsDrug
A tea made of Murraya koenigii leaves, Punica granatum and Curcuma as powder. Decoction of 12ml powder in 100ml hot water is taken twice daily at least 30 minutes before a meal.
Placebo teaDrug
Graminis Flores and Maidis stigmata as a powder. Decoction made of 12ml in 100ml hot water. To drink twice daily at least 30 Minutes before a meal.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Tea decoction made of Graminis Flores abd Maidis stigmata. Receives: Drug: Placebo tea |
| Ayurvedic herbs | Experimental | Tea decoction made of Murraya koenigii leaves, Punica granatum and Curcuma Receives: Drug: Ayurvedic Herbs |
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: T2 (Day 28)
Secondary outcomes (9)
Frequency of abdominal discomfort/Pain
Diary, daily rating of pain
Measured: last week of treatment (days 21-28)
Intensity of Abdominal Pain/Discomfort
Diary, daily rating of pain on a 100mm Visual Analog Scale
Measured: Last week of treatment (days 21-28)
Stool and diarrhea Frequency
Diary, daily counts
Measured: last week of treatment (days 21-28)
Quality of life
measured with the EQ-5D
Measured: T2 (Day 28)
IBS Specific Quality of life
measured with the IBS-QOL (Patrick, 1998)
Measured: T2 (Day 28)
Depression and Anxiety
HADS questionnaire (Hermann, 1995)
Measured: T2 (day 28)
Adequate Relief Score
Adequate Relief Score (Mangel, 1998)
Measured: at day 7, 14, 21 and 28
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 days 7, 14, 21 and 28
adverse events
all adverse events
Measured: up to week 15
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 completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 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, Prof., MD, Principal investigator, University Duisburg-Essen, Chair of Integrative Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418066
- Sponsor's protocol ID
- 11-4673 AHIB
- Acronym
- AHIB
- Status last verified
- Dec 2012
- First submitted
- 15 Aug 2011
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Ayurvedic Herbs in Diarrhoea-predominant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01418066
- Acronym / sponsor ID
- AHIB / 11-4673 AHIB
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (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.
In the present study the investigators are trying to evaluate the effect of Murraya koenigii leaves, Punica granatum and Curcuma which is administered to the patients in a combined form as tea. This study will help to evaluate the effect of these preparations scientifically in improving the IBS symptoms.
Detailed description
see above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo teaTea decoction made of Graminis Flores abd Maidis stigmata. |
| Ayurvedic herbs | Experimental | Drug: Ayurvedic HerbsTea decoction made of Murraya koenigii leaves, Punica granatum and Curcuma |
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 |
|---|---|---|
| Ayurvedic HerbsA tea made of Murraya koenigii leaves, Punica granatum and Curcuma as powder. Decoction of 12ml powder in 100ml hot water is taken twice daily at least 30 minutes before a meal. | Drug | Ayurvedic herbs |
| Placebo teaGraminis Flores and Maidis stigmata as a powder. Decoction made of 12ml in 100ml hot water. To drink twice daily at least 30 Minutes before a meal. | Drug | Placebo |
Primary outcome
irritable bowel syndrome- symptom severity score
Time frame: T2 (Day 28)
IBS-SSS(Francis, 1997)
9 secondary outcomes
Frequency of abdominal discomfort/Pain
Time frame: last week of treatment (days 21-28)
Intensity of Abdominal Pain/Discomfort
Time frame: Last week of treatment (days 21-28)
Stool and diarrhea Frequency
Time frame: last week of treatment (days 21-28)
Quality of life
Time frame: T2 (Day 28)
IBS Specific Quality of life
Time frame: T2 (Day 28)
Depression and Anxiety
Time frame: T2 (day 28)
Adequate Relief Score
Time frame: at day 7, 14, 21 and 28
Global improvement
Time frame: at days 7, 14, 21 and 28
adverse events
Time frame: up to week 15
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 6 Dec 2012.
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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, Prof., MD 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 Ayurvedic Herbs 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 6 Dec 2012. 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. Some participants in this study may receive a placebo. 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: T2 (Day 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2012.