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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 15, 2011

Last Updated Date

December 5, 2012

Start Date ^ICMJE

August 2011

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

irritable bowel syndrome- symptom severity score [ Time Frame: T2 (Day 28) ] [ Designated as safety issue: No ]

IBS-SSS(Francis, 1997)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01418066 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Other Name: n.a.
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.

Study Arm (s)

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

Enrollment ^ICMJE

Completion Date

December 2012

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01418066

Other Study ID Numbers ^ICMJE

11-4673 AHIB

Has Data Monitoring Committee

Responsible Party

Jost Langhorst, Universität Duisburg-Essen

Study Sponsor ^ICMJE

Universität Duisburg-Essen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jost Langhorst, Prof., MD

University Duisburg-Essen, Chair of Integrative Gastroenterology

Information Provided By

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

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