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Trial registered on ANZCTR


Registration number
ACTRN12608000622303
Ethics application status
Approved
Date submitted
16/10/2008
Date registered
8/12/2008
Date last updated
5/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised placebo-controlled trial of a herbal preparation in functional dyspepsia: cost effectiveness and mechanisms
Scientific title
A randomised placebo-controlled trial of a herbal preparation in functional dyspepsia: cost effectiveness and mechanisms
Secondary ID [1] 281173 0
None
Universal Trial Number (UTN)
Trial acronym
FD study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional Gastrointestinal Disorders 3778 0
Condition category
Condition code
Oral and Gastrointestinal 3951 3951 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is designed to compare the effects of 4 different intervention groups with a double dummy technique. Intervention group 1: Iberogast, herbal medication, 20 drops orally 3 times a day for 4 week. Intervention group 2: Esomeprazole, Proton Pump Inhibitor (PPI), 20mg orally daily for 4 weeks. Intervention group 3:Oral Esomeprazole 20mg daily and oral Iberogast 20 drops 3 times a day for 4 weeks. Intervention group 4: oral placebo tablet daily and oral placebo liquid 20 drops 3 times a day for 4 weeks. All Responders to the treatments will continue with intervention group 4 (placebo) for week 6 and week 8. All intervention groups will have Endoscopy with biopsies, pregnancy urine test and Laboratory values only at screening. Questionnaires, nutrients challenge drink and blood for immune activation will be obtained at visits
Intervention code [1] 3490 0
Treatment: Other
Comparator / control treatment
Placebo sugar pill will be pink in colour and administered once daily for 4 weeks and an additional 4 weeks if patients are considered responders. Liquid placebo will contain 28-34% ethanol, herbal and liquorice flavours similar taste to active herbal medication.
Control group
Active

Outcomes
Primary outcome [1] 4852 0
Cost- effectiveness will be assessed with a questionnaire regarding their on going costs relating to Irritable Bowel Symptoms or Functional Dyspesia whilst study participation.
Timepoint [1] 4852 0
This assessment will be conducted at week 0, week 2, week 4 and if identified as responders week 6 and week 8.
Primary outcome [2] 5172 0
Validated questionnnaires such as Leeds Dyspepsia Questionnaire (LDQ), Gastointestinal Syptoms (GIS), Hospital Anxiety and Depression scale (HADS) and Nepean Dyspepsia Index (NDI) will be used. Nutrients challenge drink and bloods immune activation will assist in clinical efficacy.
Timepoint [2] 5172 0
After screening the study will be conducted from Baseline until completion in 4 weeks. If patients are identified as responders the trial will continue for these patient for an additional 4 weeks.
Secondary outcome [1] 8196 0
The association between the clinical response (complete resolution or substantial improvement of symptoms) and changes of visceral sencory function before and during treatment as assessed with a nutrient challenge
Timepoint [1] 8196 0
These outcomes will be assessed at week 0, week 2 and week 4
Secondary outcome [2] 8197 0
From a blood sample the role of markers of immune activation (cytokine production, and presence of activated, gut homing inflammatory cells) and/or genectic variables in predicting the response to therapy are obtained.
Timepoint [2] 8197 0
Blood sample obtained at week 0 and week 4
Secondary outcome [3] 8198 0
If a patient reports complete resolution of symptoms or near complete resolution of symptoms at week 4 they will be considered a responder and continue with placebo treatment until week 6. If at week 6 their symptoms have deteriorated they are considered relapsers. Relapsers do not require to complete week 8. Responders at week 6 continue with placebo treatment until week 8. If at week 8 they maintain complete resolution or near complete resolution of symptoms they are considered a placebo withdraw relapser otherwise they will be called a sustained responder.
Timepoint [3] 8198 0
Assessment made at week 6 and week 8

Eligibility
Key inclusion criteria
Patient meeting diagnostic criteria for Functional Dyspesia. Outpatients with a suspected diagnosis of functional dyspepsia based upon modified Rome III criteria.Sufficient understanding of English. Non Pregnant.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-consent. Insufficent English. Predominant reflux symptoms. Predominant Irritable Bowel Syndrome. Ongoing medication known to influence Gastrointestinal (GI) motility or acid secretion

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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 4018 0
Government body
Name [1] 4018 0
National Health and Medical Research Council (NHMRC) CAM Grant
Address [1] 4018 0
Level5, 20 Allara Street
Canberra ACT 2601
Country [1] 4018 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Dr Jane Andrews
Gastroenterology Ward Q7
North Tce
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 3611 0
Government body
Name [1] 3611 0
Department of Health
Address [1] 3611 0
11 Waymouth Street Adelaide SA 5000
Country [1] 3611 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6024 0
Royal Adelaide Human Research Ethics Committee
Ethics committee address [1] 6024 0
Royal Adelaide Hospital
Level 3 Hanson Institute
North Terrace
Adelaide SA 5000
Ethics committee country [1] 6024 0
Australia
Date submitted for ethics approval [1] 6024 0
14/08/2008
Approval date [1] 6024 0
02/09/2008
Ethics approval number [1] 6024 0
080813
Ethics committee name [2] 6025 0
Repatriation General Hospital Human Research Ethics Committee
Ethics committee address [2] 6025 0
Repatriation General Hospital
Daws Road,
Daw Park SA 5041
Ethics committee country [2] 6025 0
Australia
Date submitted for ethics approval [2] 6025 0
Approval date [2] 6025 0
Ethics approval number [2] 6025 0
38/08

Summary
Brief summary
.








.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28993 0
Address 28993 0
Country 28993 0
Phone 28993 0
Fax 28993 0
Email 28993 0
Contact person for public queries
Name 12150 0
Dr Jane Andrews
Address 12150 0
Royal Adelaide Hospital
Gastroenterology Ward Q7
North Terrace
Adelaide SA 5000
Country 12150 0
Australia
Phone 12150 0
088222 5207
Fax 12150 0
Email 12150 0
jane.andrews@health.sa.gov.au
Contact person for scientific queries
Name 3078 0
Dr Jane Andrews
Address 3078 0
Gastroenterology Ward Q7
North Terrace
Adelaide SA 5000
Country 3078 0
Australia
Phone 3078 0
088222 5207
Fax 3078 0
Email 3078 0
jane.andrews@health.sa.gov.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary