Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome (AHIB)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jost Langhorst, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01418066
First received: August 15, 2011
Last updated: December 5, 2012
Last verified: December 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 Universität Duisburg-Essen:

Primary Outcome Measures:
  • irritable bowel syndrome- symptom severity score [ Time Frame: T2 (Day 28) ] [ Designated as safety issue: No ]
    IBS-SSS(Francis, 1997)


Secondary Outcome Measures:
  • Frequency of abdominal discomfort/Pain [ Time Frame: last week of treatment (days 21-28) ] [ Designated as safety issue: No ]
    Diary, daily rating of pain

  • Intensity of Abdominal Pain/Discomfort [ Time Frame: Last week of treatment (days 21-28) ] [ Designated as safety issue: No ]
    Diary, daily rating of pain on a 100mm Visual Analog Scale

  • Stool and diarrhea Frequency [ Time Frame: last week of treatment (days 21-28) ] [ Designated as safety issue: No ]
    Diary, daily counts

  • Quality of life [ Time Frame: T2 (Day 28) ] [ Designated as safety issue: No ]
    measured with the EQ-5D

  • IBS Specific Quality of life [ Time Frame: T2 (Day 28) ] [ Designated as safety issue: No ]
    measured with the IBS-QOL (Patrick, 1998)

  • Depression and Anxiety [ Time Frame: T2 (day 28) ] [ Designated as safety issue: No ]
    HADS questionnaire (Hermann, 1995)

  • Adequate Relief Score [ Time Frame: at day 7, 14, 21 and 28 ] [ Designated as safety issue: No ]
    Adequate Relief Score (Mangel, 1998)

  • Global improvement [ Time Frame: at days 7, 14, 21 and 28 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jost Langhorst, Prof. Dr., Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT01418066     History of Changes
Other Study ID Numbers: 11-4673 AHIB
Study First Received: August 15, 2011
Last Updated: December 5, 2012
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on October 30, 2014