Irritable Bowel Syndrome
Conditions
Brief 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.
Detailed description
see above
Interventions
DRUGAyurvedic 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.
DRUGPlacebo 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.
Sponsors
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| irritable bowel syndrome- symptom severity score | T2 (Day 28) | IBS-SSS(Francis, 1997) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | T2 (Day 28) | measured with the EQ-5D |
| IBS Specific Quality of life | T2 (Day 28) | measured with the IBS-QOL (Patrick, 1998) |
| Depression and Anxiety | T2 (day 28) | HADS questionnaire (Hermann, 1995) |
| Adequate Relief Score | at day 7, 14, 21 and 28 | Adequate Relief Score (Mangel, 1998) |
| Stool and diarrhea Frequency | last week of treatment (days 21-28) | Diary, daily counts |
| Intensity of Abdominal Pain/Discomfort | Last week of treatment (days 21-28) | Diary, daily rating of pain on a 100mm Visual Analog Scale |
| Global improvement | at days 7, 14, 21 and 28 | 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 | up to week 15 | all adverse events |
| Frequency of abdominal discomfort/Pain | last week of treatment (days 21-28) | Diary, daily rating of pain |
Countries
Germany
Outcome results
None listed