Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome (AHIB)
This study has been completed.
Sponsor:
Universität Duisburg-Essen
Information provided by (Responsible Party):
Jost Langhorst, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01418066
First received: August 15, 2011
Last updated: December 5, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Irritable Bowel Syndrome |
Drug: Ayurvedic Herbs Drug: Placebo tea |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Feasibility and Safety of Ayurvedic Herbs in Diarrhoea-predominant Irritable Bowel Syndrome |
Resource links provided by NLM:
Further study details as provided by Universität Duisburg-Essen:
Primary Outcome Measures:
- irritable bowel syndrome- symptom severity score [ Time Frame: T2 (Day 28) ] [ Designated as safety issue: No ]IBS-SSS(Francis, 1997)
Secondary Outcome Measures:
- Frequency of abdominal discomfort/Pain [ Time Frame: last week of treatment (days 21-28) ] [ Designated as safety issue: No ]Diary, daily rating of pain
- Intensity of Abdominal Pain/Discomfort [ Time Frame: Last week of treatment (days 21-28) ] [ Designated as safety issue: No ]Diary, daily rating of pain on a 100mm Visual Analog Scale
- Stool and diarrhea Frequency [ Time Frame: last week of treatment (days 21-28) ] [ Designated as safety issue: No ]Diary, daily counts
- Quality of life [ Time Frame: T2 (Day 28) ] [ Designated as safety issue: No ]measured with the EQ-5D
- IBS Specific Quality of life [ Time Frame: T2 (Day 28) ] [ Designated as safety issue: No ]measured with the IBS-QOL (Patrick, 1998)
- Depression and Anxiety [ Time Frame: T2 (day 28) ] [ Designated as safety issue: No ]HADS questionnaire (Hermann, 1995)
- Adequate Relief Score [ Time Frame: at day 7, 14, 21 and 28 ] [ Designated as safety issue: No ]Adequate Relief Score (Mangel, 1998)
- Global improvement [ Time Frame: at days 7, 14, 21 and 28 ] [ Designated as safety issue: No ]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
- adverse events [ Time Frame: up to week 15 ] [ Designated as safety issue: Yes ]all adverse events
| Enrollment: | 32 |
| Study Start Date: | August 2011 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Tea decoction made of Graminis Flores abd Maidis stigmata.
|
Drug: Placebo tea
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.
Other Name: n.a.
|
|
Experimental: Ayurvedic herbs
Tea decoction made of Murraya koenigii leaves, Punica granatum and Curcuma
|
Drug: Ayurvedic Herbs
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.
Other Name: n.a.
|
Detailed Description:
see above
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418066
Locations
| Germany | |
| Klinik für Naturheilkunde und Integrative Medizin | |
| Essen, NRW, Germany, 45276 | |
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
| Principal Investigator: | Jost Langhorst, Prof., MD | University Duisburg-Essen, Chair of Integrative Gastroenterology |
More Information
No publications provided
| Responsible Party: | Jost Langhorst, Prof. Dr., Universität Duisburg-Essen |
| ClinicalTrials.gov Identifier: | NCT01418066 History of Changes |
| Other Study ID Numbers: | 11-4673 AHIB |
| Study First Received: | August 15, 2011 |
| Last Updated: | December 5, 2012 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Diarrhea Irritable Bowel Syndrome Signs and Symptoms, Digestive Signs and Symptoms Colonic Diseases, Functional |
Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013