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Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome (AHIB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01418066
First Posted: August 16, 2011
Last Update Posted: December 6, 2012
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.
Information provided by (Responsible Party):
Jost Langhorst, Universität Duisburg-Essen
  Purpose
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.

Condition Intervention
Irritable Bowel Syndrome Drug: Ayurvedic Herbs Drug: Placebo tea

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility and Safety of Ayurvedic Herbs in Diarrhoea-predominant Irritable Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by Jost Langhorst, Universität Duisburg-Essen:

Primary Outcome Measures:
  • irritable bowel syndrome- symptom severity score [ Time Frame: T2 (Day 28) ]
    IBS-SSS(Francis, 1997)


Secondary Outcome Measures:
  • 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


Enrollment: 32
Study Start Date: August 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:
see above
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Germany
Klinik für Naturheilkunde und Integrative Medizin
Essen, NRW, Germany, 45276
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
Principal Investigator: Jost Langhorst, Prof., MD University Duisburg-Essen, Chair of Integrative Gastroenterology
  More Information

Responsible Party: Jost Langhorst, Prof. Dr., Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT01418066     History of Changes
Other Study ID Numbers: 11-4673 AHIB
First Submitted: August 15, 2011
First Posted: August 16, 2011
Last Update Posted: December 6, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Syndrome
Diarrhea
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases