Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome
AHIB
Feasibility and Safety of Ayurvedic Herbs in Diarrhoea-predominant Irritable Bowel Syndrome
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 15, 2011
CompletedFirst Posted
Study publicly available on registry
August 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedDecember 6, 2012
December 1, 2012
1.3 years
August 15, 2011
December 5, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
irritable bowel syndrome- symptom severity score
IBS-SSS(Francis, 1997)
T2 (Day 28)
Secondary Outcomes (9)
Frequency of abdominal discomfort/Pain
last week of treatment (days 21-28)
Intensity of Abdominal Pain/Discomfort
Last week of treatment (days 21-28)
Stool and diarrhea Frequency
last week of treatment (days 21-28)
Quality of life
T2 (Day 28)
IBS Specific Quality of life
T2 (Day 28)
- +4 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORTea decoction made of Graminis Flores abd Maidis stigmata.
Ayurvedic herbs
EXPERIMENTALTea decoction made of Murraya koenigii leaves, Punica granatum and Curcuma
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinik für Naturheilkunde und Integrative Medizin
Essen, North Rhine-Westphalia, 45276, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jost Langhorst, Prof., MD
University Duisburg-Essen, Chair of Integrative Gastroenterology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
August 15, 2011
First Posted
August 16, 2011
Study Start
August 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
December 6, 2012
Record last verified: 2012-12