Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome

NCT ID: NCT01418066

Last Updated: 2012-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-12-31

Brief Summary

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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

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see above

Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Tea decoction made of Graminis Flores abd Maidis stigmata.

Group Type PLACEBO_COMPARATOR

Placebo tea

Intervention Type DRUG

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.

Ayurvedic herbs

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

Group Type EXPERIMENTAL

Ayurvedic Herbs

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universität Duisburg-Essen

OTHER

Sponsor Role lead

Responsible Party

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Jost Langhorst

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jost Langhorst, Prof., MD

Role: PRINCIPAL_INVESTIGATOR

University Duisburg-Essen, Chair of Integrative Gastroenterology

Locations

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Klinik für Naturheilkunde und Integrative Medizin

Essen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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11-4673 AHIB

Identifier Type: -

Identifier Source: org_study_id