Dyspeptic symptoms Gastric histology Biochemical analysis Adverse events Boesenbergia rotunda functional dyspepsia Short-
Conditions
Interventions
Participants in the treatment group received 2 capsules of extracts from Boesenbergia rotunda three times daily for four weeks.,Participants in the control group received one capsule of omeprazole (20
Experimental Dietary Supplement,Active Comparator Drug
extracts from Boesenbergia rotunda ,omeprazole
Sponsors
Division of Gastrohepatology, Department of Internal Medicine, Chiang Mai University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants entered into the run-in period were aged ≥18 years, had suffered one or more of the four major dyspeptic symptoms (epigastric pain, epigastric burning, early satiety and bothersome postprandial fullness) for ≥6 months, and had continually experienced dyspeptic symptoms of at least moderate severity within the last 3 months; this was assessed using a dyspepsia symptom questionnaire based on the Rome III criteria. Endoscopic examination was done ≤7 days before the start of the study. None of the participants had any endoscopic evidence that would explain the dyspeptic symptoms, such as reflux esophagitis, active gastric or duodenal ulcers or acute gastroduodenal mucosal lesions within 6 months of the start of the study.
Exclusion criteria
Exclusion criteria: Participants were excluded if they had a history of upper gastrointestinal tract surgery; a history of H. pylori eradication therapy within the last 6 months; a history of malignant disease; a diagnosis of irritable bowel syndrome; severe liver, heart or kidney diseases; or current or past evidence of uncontrolled diabetes mellitus, psychosomatic disorders, such as depressive and anxiety disorders, and drug or alcohol abuse. Pregnant or breastfeeding women were also excluded. Participants were not allowed to be treated with H2-receptor antagonists, antacids, prokinetics, antidepressant drugs, tranquilizers, anticholinergic agents, cholinergic agents or non-steroidal anti-inflammatory drugs within 1 week of study commencement or during the study. Participants who had used any of these drugs discontinued the therapy at least 1 week before the intervention as a wash-out period. Participants with a chief complaint of heartburn or regurgitation were also excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dyspepsia symptoms 4 weeks Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastric histologic assessment 4 weeks updated Sydney protocol | — |
Countries
Thailand
Contacts
Public ContactTaned Chitapanarux
Chiang Mai University
Outcome results
None listed