Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome (AHIB)

• ClinicalTrials.gov Identifier: NCT01418066
• Recruitment Status: Completed
• First Posted: August 16, 2011
• Last Update Posted: December 6, 2012
• Sponsor: Universität Duisburg-Essen
• Information provided by (Responsible Party): Jost Langhorst, Universität Duisburg-Essen

Tracking Information

• First Submitted Date: August 15, 2011
• First Posted Date: August 16, 2011
• Last Update Posted Date: December 6, 2012
• Study Start Date: August 2011
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 15, 2011)

irritable bowel syndrome- symptom severity score [ Time Frame: T2 (Day 28) ]

IBS-SSS(Francis, 1997)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 15, 2011)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome
• Official Title: Feasibility and Safety of Ayurvedic Herbs in Diarrhoea-predominant Irritable Bowel Syndrome
• 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
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Irritable Bowel Syndrome

Intervention

• 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.
• 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.

Study Arms

• Placebo Comparator: Placebo
  Tea decoction made of Graminis Flores abd Maidis stigmata.
  Intervention: Drug: Placebo tea
• Experimental: Ayurvedic herbs
  Tea decoction made of Murraya koenigii leaves, Punica granatum and Curcuma
  Intervention: Drug: Ayurvedic Herbs

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 15, 2011): 32
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT01418066
• Other Study ID Numbers: 11-4673 AHIB
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jost Langhorst, Universität Duisburg-Essen
• Original Responsible Party: Jost langhorst, MD, Prof, University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
• Current Study Sponsor: Universität Duisburg-Essen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jost Langhorst, Prof., MD; University Duisburg-Essen, Chair of Integrative Gastroenterology

• PRS Account: Universität Duisburg-Essen
• Verification Date: December 2012