Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome (AHIB)

Feasibility and Safety of Ayurvedic Herbs in Diarrhoea-predominant Irritable Bowel Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Placebo tea; Drug: Ayurvedic Herbs

Detailed Description

see above

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Essen, NRW, Germany, 45276
      • Klinik für Naturheilkunde und Integrative Medizin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
irritable bowel syndrome- symptom severity score	IBS-SSS(Francis, 1997)	T2 (Day 28)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of abdominal discomfort/Pain	Diary, daily rating of pain	last week of treatment (days 21-28)
Intensity of Abdominal Pain/Discomfort	Diary, daily rating of pain on a 100mm Visual Analog Scale	Last week of treatment (days 21-28)
Stool and diarrhea Frequency	Diary, daily counts	last week of treatment (days 21-28)
Quality of life	measured with the EQ-5D	T2 (Day 28)
IBS Specific Quality of life	measured with the IBS-QOL (Patrick, 1998)	T2 (Day 28)
Depression and Anxiety	HADS questionnaire (Hermann, 1995)	T2 (day 28)
Adequate Relief Score	Adequate Relief Score (Mangel, 1998)	at day 7, 14, 21 and 28
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	at days 7, 14, 21 and 28
adverse events	all adverse events	up to week 15

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Investigators: Principal Investigator: Jost Langhorst, Prof., MD, University Duisburg-Essen, Chair of Integrative Gastroenterology

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: August 15, 2011
• First Submitted That Met QC Criteria: August 15, 2011
• First Posted (ESTIMATE): August 16, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 6, 2012
• Last Update Submitted That Met QC Criteria: December 5, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: 11-4673 AHIB