Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome (AHIB)
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|ClinicalTrials.gov Identifier: NCT01418066|
Recruitment Status : Completed
First Posted : August 16, 2011
Last Update Posted : December 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Drug: Ayurvedic Herbs Drug: Placebo tea||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Feasibility and Safety of Ayurvedic Herbs in Diarrhoea-predominant Irritable Bowel Syndrome|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
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.
- irritable bowel syndrome- symptom severity score [ Time Frame: T2 (Day 28) ]IBS-SSS(Francis, 1997)
- Frequency of abdominal discomfort/Pain [ Time Frame: last week of treatment (days 21-28) ]Diary, daily rating of pain
- Intensity of Abdominal Pain/Discomfort [ Time Frame: Last week of treatment (days 21-28) ]Diary, daily rating of pain on a 100mm Visual Analog Scale
- Stool and diarrhea Frequency [ Time Frame: last week of treatment (days 21-28) ]Diary, daily counts
- Quality of life [ Time Frame: T2 (Day 28) ]measured with the EQ-5D
- IBS Specific Quality of life [ Time Frame: T2 (Day 28) ]measured with the IBS-QOL (Patrick, 1998)
- Depression and Anxiety [ Time Frame: T2 (day 28) ]HADS questionnaire (Hermann, 1995)
- Adequate Relief Score [ Time Frame: at day 7, 14, 21 and 28 ]Adequate Relief Score (Mangel, 1998)
- Global improvement [ Time Frame: 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 [ Time Frame: up to week 15 ]all adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418066
|Klinik für Naturheilkunde und Integrative Medizin|
|Essen, NRW, Germany, 45276|
|Principal Investigator:||Jost Langhorst, Prof., MD||University Duisburg-Essen, Chair of Integrative Gastroenterology|