Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Ayurvedic Herbs; Drug: Placebo tea

• Registration Number: NCT01418066
• Lead Sponsor: Universität Duisburg-Essen

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-05
• Last Update Posted: 2012-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ayurvedic herbs	Ayurvedic Herbs	Tea decoction made of Murraya koenigii leaves, Punica granatum and Curcuma
Placebo	Placebo tea	Tea decoction made of Graminis Flores abd Maidis stigmata.

Primary Outcome Measures

Name	Time	Method
irritable bowel syndrome- symptom severity score	T2 (Day 28)	IBS-SSS(Francis, 1997)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Klinik für Naturheilkunde und Integrative Medizin; 🇩🇪 Essen, NRW, Germany