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A randomised placebo-controlled trial of a herbal preparation in functional dyspepsia: cost effectiveness and mechanisms

A randomised placebo-controlled trial of a herbal preparation in functional dyspepsia: cost effectiveness and mechanisms

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000622303
Acronym
FD study
Enrollment
480
Registered
2008-12-08
Start date
2009-01-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

. .

Interventions

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 da

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

Sponsors

Royal Adelaide Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

Non-consent. Insufficent English. Predominant reflux symptoms. Predominant Irritable Bowel Syndrome. Ongoing medication known to influence Gastrointestinal (GI) motility or acid secretion

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026