We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome (AHIB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01418066
Recruitment Status : Completed
First Posted : August 16, 2011
Last Update Posted : December 6, 2012
Sponsor:
Information provided by (Responsible Party):
Jost Langhorst, Universität Duisburg-Essen

Tracking Information
First Submitted Date  ICMJE August 15, 2011
First Posted Date  ICMJE August 16, 2011
Last Update Posted Date December 6, 2012
Study Start Date  ICMJE August 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2011)
irritable bowel syndrome- symptom severity score [ Time Frame: T2 (Day 28) ]
IBS-SSS(Francis, 1997)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2011)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01418066
Other Study ID Numbers  ICMJE 11-4673 AHIB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE 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  ICMJE Universität Duisburg-Essen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jost Langhorst, Prof., MD University Duisburg-Essen, Chair of Integrative Gastroenterology
PRS Account Universität Duisburg-Essen
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP