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Trial registered on ANZCTR
Registration number
ACTRN12609000085279
Ethics application status
Approved
Date submitted
9/10/2008
Date registered
6/02/2009
Date last updated
5/09/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
A double-blind, randomised study on the effects of STW 5 on symptoms and immunologic function in patients with irritable bowel syndrome
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Scientific title
A double-blind, randomised study on the effects of STW 5 on symptoms and immunologic function in patients with irritable bowel syndrome
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Secondary ID [1]
281172
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Irritable Bowel Syndrome
3786
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Condition category
Condition code
Oral and Gastrointestinal
3962
3962
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0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This is a cross over study examining the effects of a herbal preperation, Iberogast (STW 5) and placebo for patients suffering from Irritable Bowel Syndrome compared to healthy controls. Iberogast is a liquid consisting of 9 plant extracts. Each treatment arm is conducted over 2 weeks. Study medication is administered at 20 drops 3 times per day, orally. With a washout period of 1 week between treatment arms.
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Intervention code [1]
3502
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Treatment: Other
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Intervention code [2]
3947
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Early detection / Screening
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Comparator / control treatment
cross over design: healthy volunteers and Iriitable Bowel Syndrome (IBS) subjects will receive 2 weeks of herbal preparation and 2 weeks of placebo. The placebo has been prepared to taste similar to Iberogast. Placebo liquid is taken orally, 20 drops 3 times a day for the duration of 2 weeks. The Placebo consists of ethanol 28-34% (v/v),herbal flavour and liquorice flavour. A Washout period of one week between treatments.
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Control group
Active
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Outcomes
Primary outcome [1]
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To assess the improvement of symptoms in patients with IBS during treatment with the herbal preparation, Iberogast (STW 5) and placebo the subject will complete previously standardised questionnaires
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Assessment method [1]
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Timepoint [1]
4866
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Visit 1 baseline, visit 2 week 2, visit 3 week 4, visit 4 week 5, visit 5 week 7.
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Secondary outcome [1]
8210
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Through analysis subjects blood sample at visit 1,3,4 and 5 we will measure the influence of the treatment on Peripheral Blood Monouclear cell (PBMC)-mediated cytokine secretion and gut homing T cells.
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Assessment method [1]
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Timepoint [1]
8210
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Visit 1 baseline, visit 3 week 4, visit 4 week 5, visit 5 week 7
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Eligibility
Key inclusion criteria
Symptoms consitent with IBS according to the Rome III criteria; Not recieved antibiotics 8 wks prior; Not taking immunosuppressive medications;No Laxatives, no prokinetic drugs for 2 weeks;
Able to sign consent
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Previous abdominal or gynaecological surgery (except appendectomies and cholecystectomies) previous gastrointestinal cancer;Known peptic ulcers;pregnancy or breastfeeding;chronic inflammatory disease, cardiovascular disease; respiratory disease;Diabetes mellitus; Epilepsy;
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/01/2007
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
3970
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Commercial sector/Industry
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Name [1]
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STEIGERWALD Arzneimittelwerk GmbH
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Address [1]
3970
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Havelstr. 5, D-64295 Darmstadt
Adelaide SA 5000
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Country [1]
3970
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Germany
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Funding source category [2]
4458
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Hospital
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Name [2]
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Royal Adelaide Hospital Gastroenterology & Hepatology Unit
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Address [2]
4458
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Ward Q7
North Terrace
Adelaide SA 5000
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Country [2]
4458
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Australia
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Primary sponsor type
Hospital
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Name
Royal Adelaide Hospital Gastroenterology and Hepatology
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Address
Ward Q7
North Terrace
Adelaide SA 5000
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Country
Australia
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Secondary sponsor category [1]
4017
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Government body
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Name [1]
4017
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Department of Health (DoH)
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Address [1]
4017
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Level 13, 11 Waymouth Str, Adelaide SA 5000
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Country [1]
4017
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Australia
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
The study is designed to provide information about the way the gastroinstestinal tract responds to the treatment of herbal medication Iberogast.We seek to determine the effects of Iberogast on symptoms and stool frequencey as well as immunologic function.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
29000
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Country
29000
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Phone
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Fax
29000
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Email
29000
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Contact person for public queries
Name
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Dr Jane Andrews
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Address
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Gastroenterolgy Unit Ward Q7
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
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Country
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Australia
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Phone
12157
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088222 5207
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Fax
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Email
12157
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[email protected]
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Contact person for scientific queries
Name
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Dr Jane Andrews
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Address
3085
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Gastroenterolgy Unit Ward Q7
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
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Country
3085
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Australia
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Phone
3085
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088222 5207
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Fax
3085
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Email
3085
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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