Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

— AHIB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418066
• Other study ID #: 11-4673 AHIB
• Status: Completed
• Phase: N/A
• First received: August 15, 2011
• Last updated: December 5, 2012
• Start date: August 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Description:

see above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Klinik für Naturheilkunde und Integrative Medizin	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	irritable bowel syndrome- symptom severity score	IBS-SSS(Francis, 1997)	T2 (Day 28)	No
Secondary	Frequency of abdominal discomfort/Pain	Diary, daily rating of pain	last week of treatment (days 21-28)	No
Secondary	Intensity of Abdominal Pain/Discomfort	Diary, daily rating of pain on a 100mm Visual Analog Scale	Last week of treatment (days 21-28)	No
Secondary	Stool and diarrhea Frequency	Diary, daily counts	last week of treatment (days 21-28)	No
Secondary	Quality of life	measured with the EQ-5D	T2 (Day 28)	No
Secondary	IBS Specific Quality of life	measured with the IBS-QOL (Patrick, 1998)	T2 (Day 28)	No
Secondary	Depression and Anxiety	HADS questionnaire (Hermann, 1995)	T2 (day 28)	No
Secondary	Adequate Relief Score	Adequate Relief Score (Mangel, 1998)	at day 7, 14, 21 and 28	No
Secondary	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	No
Secondary	adverse events	all adverse events	up to week 15	Yes