Trial Review

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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
Scientific title
A double-blind, randomised study on the effects of STW 5 on symptoms and immunologic function in patients with irritable bowel syndrome
Secondary ID [1] 281172 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable Bowel Syndrome 3786 0
Condition category
Condition code
Oral and Gastrointestinal 3962 3962 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 3502 0
Treatment: Other
Intervention code [2] 3947 0
Early detection / Screening
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.
Control group
Active

Outcomes
Primary outcome [1] 4866 0
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
Timepoint [1] 4866 0
Visit 1 baseline, visit 2 week 2, visit 3 week 4, visit 4 week 5, visit 5 week 7.
Secondary outcome [1] 8210 0
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.
Timepoint [1] 8210 0
Visit 1 baseline, visit 3 week 4, visit 4 week 5, visit 5 week 7

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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3970 0
Commercial sector/Industry
Name [1] 3970 0
STEIGERWALD Arzneimittelwerk GmbH
Country [1] 3970 0
Germany
Funding source category [2] 4458 0
Hospital
Name [2] 4458 0
Royal Adelaide Hospital Gastroenterology & Hepatology Unit
Country [2] 4458 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital Gastroenterology and Hepatology
Address
Ward Q7
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 4017 0
Government body
Name [1] 4017 0
Department of Health (DoH)
Address [1] 4017 0
Level 13, 11 Waymouth Str, Adelaide SA 5000
Country [1] 4017 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29000 0
Address 29000 0
Country 29000 0
Phone 29000 0
Fax 29000 0
Email 29000 0
Contact person for public queries
Name 12157 0
Dr Jane Andrews
Address 12157 0
Gastroenterolgy Unit Ward Q7
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 12157 0
Australia
Phone 12157 0
088222 5207
Fax 12157 0
Email 12157 0
jane.andrews@health.sa.gov.au
Contact person for scientific queries
Name 3085 0
Dr Jane Andrews
Address 3085 0
Gastroenterolgy Unit Ward Q7
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 3085 0
Australia
Phone 3085 0
088222 5207
Fax 3085 0
Email 3085 0
jane.andrews@health.sa.gov.au

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.