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

Not Applicable

Completed

• Conditions: Functional Gastrointestinal Disorders; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12608000622303
• Lead Sponsor: Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 480

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cost- effectiveness will be assessed with a questionnaire regarding their on going costs relating to Irritable Bowel Symptoms or Functional Dyspesia whilst study participation.[This assessment will be conducted at week 0, week 2, week 4 and if identified as responders week 6 and week 8.];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.[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.]