Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome

Study Overview
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Brief Summary
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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
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see above

Official Title
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Feasibility and Safety of Ayurvedic Herbs in Diarrhoea-predominant Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Ayurvedic Herbs
* Drug: Placebo tea


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Tea decoction made of Graminis Flores abd Maidis stigmata. | Drug: Placebo tea<br>* 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.<br>|
| Experimental: Ayurvedic herbs<br>Tea decoction made of Murraya koenigii leaves, Punica granatum and Curcuma | Drug: Ayurvedic Herbs<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| irritable bowel syndrome- symptom severity score | IBS-SSS(Francis, 1997) | T2 (Day 28) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of abdominal discomfort/Pain | Diary, daily rating of pain | last week of treatment (days 21-28) | 
| Intensity of Abdominal Pain/Discomfort | Diary, daily rating of pain on a 100mm Visual Analog Scale | Last week of treatment (days 21-28) | 
| Stool and diarrhea Frequency | Diary, daily counts | last week of treatment (days 21-28) | 
| Quality of life | measured with the EQ-5D | T2 (Day 28) | 
| IBS Specific Quality of life | measured with the IBS-QOL (Patrick, 1998) | T2 (Day 28) | 
| Depression and Anxiety | HADS questionnaire (Hermann, 1995) | T2 (day 28) | 
| Adequate Relief Score | Adequate Relief Score (Mangel, 1998) | 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 | at days 7, 14, 21 and 28 | 
| adverse events | all adverse events | up to week 15 |