search
Back to results

Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome (AHIB)

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Ayurvedic Herbs
Placebo tea
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik für Naturheilkunde und Integrative Medizin

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Ayurvedic herbs

Arm Description

Tea decoction made of Graminis Flores abd Maidis stigmata.

Tea decoction made of Murraya koenigii leaves, Punica granatum and Curcuma

Outcomes

Primary Outcome Measures

irritable bowel syndrome- symptom severity score
IBS-SSS(Francis, 1997)

Secondary Outcome Measures

Frequency of abdominal discomfort/Pain
Diary, daily rating of pain
Intensity of Abdominal Pain/Discomfort
Diary, daily rating of pain on a 100mm Visual Analog Scale
Stool and diarrhea Frequency
Diary, daily counts
Quality of life
measured with the EQ-5D
IBS Specific Quality of life
measured with the IBS-QOL (Patrick, 1998)
Depression and Anxiety
HADS questionnaire (Hermann, 1995)
Adequate Relief Score
Adequate Relief Score (Mangel, 1998)
Global improvement
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
all adverse events

Full Information

First Posted
August 15, 2011
Last Updated
December 5, 2012
Sponsor
Universität Duisburg-Essen
search

1. Study Identification

Unique Protocol Identification Number
NCT01418066
Brief Title
Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome
Acronym
AHIB
Official Title
Feasibility and Safety of Ayurvedic Herbs in Diarrhoea-predominant Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Tea decoction made of Graminis Flores abd Maidis stigmata.
Arm Title
Ayurvedic herbs
Arm Type
Experimental
Arm Description
Tea decoction made of Murraya koenigii leaves, Punica granatum and Curcuma
Intervention Type
Drug
Intervention Name(s)
Ayurvedic Herbs
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo tea
Intervention Description
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.
Primary Outcome Measure Information:
Title
irritable bowel syndrome- symptom severity score
Description
IBS-SSS(Francis, 1997)
Time Frame
T2 (Day 28)
Secondary Outcome Measure Information:
Title
Frequency of abdominal discomfort/Pain
Description
Diary, daily rating of pain
Time Frame
last week of treatment (days 21-28)
Title
Intensity of Abdominal Pain/Discomfort
Description
Diary, daily rating of pain on a 100mm Visual Analog Scale
Time Frame
Last week of treatment (days 21-28)
Title
Stool and diarrhea Frequency
Description
Diary, daily counts
Time Frame
last week of treatment (days 21-28)
Title
Quality of life
Description
measured with the EQ-5D
Time Frame
T2 (Day 28)
Title
IBS Specific Quality of life
Description
measured with the IBS-QOL (Patrick, 1998)
Time Frame
T2 (Day 28)
Title
Depression and Anxiety
Description
HADS questionnaire (Hermann, 1995)
Time Frame
T2 (day 28)
Title
Adequate Relief Score
Description
Adequate Relief Score (Mangel, 1998)
Time Frame
at day 7, 14, 21 and 28
Title
Global improvement
Description
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
Time Frame
at days 7, 14, 21 and 28
Title
adverse events
Description
all adverse events
Time Frame
up to week 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jost Langhorst, Prof., MD
Organizational Affiliation
University Duisburg-Essen, Chair of Integrative Gastroenterology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Naturheilkunde und Integrative Medizin
City
Essen
State/Province
NRW
ZIP/Postal Code
45276
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome

We'll reach out to this number within 24 hrs