Heartburn pyrosis
Conditions
Interventions
All patients will receive in one period either a placebo or Iberogast (20 drops
three times daily) for at least 4 weeks, followed by a second period in which
they will receive the other study medica
heartburn
pyrosis
reflux
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Age above 18 * A history of dyspepsia (according to the Rome IV criteria) with heartburn * Upper gastro-intestinal causes of the complaints excluded via gastroscopy with in addition an abdominal echography if deemed necessary by the physician
Exclusion criteria
Exclusion criteria: * Surgery of the GI tract other than appendectomy or cholecystectomy * Use of any medication with a potential effect on gastrointestinal motility, secretion or sensitivity that cannot be stopped for the duration of the study (e.g. proton pump inhibitors, H2-blockers, antidepressants, prokinetics) * Proton pump inhibitors must be stopped at least 7 days before start of the study * Known Barrett*s oesophagus * History of GI cancer * Known allergy to one of the ingredients of Iberogast * Known diabetes * Severe and clinically unstable concomitant disease (e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders) * Pregnancy (women will be asked if they are pregnant)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Number of gastro-oesophageal reflux episodes during the 24-hr study (both mixed/liquid reflux episodes and both acidic and non-acidic episodes) Proportion of acid and non-acid reflux episodes Total acid exposure time during 24-hour pH-impedance studies Quality of life (using the Short Form Nepean Dyspepsia Index (SF-NDI) Questionnaire) Oesophageal sensitivity to acid perfusion Time to symptoms during oesophageal acid exposure Time to pain during oesophageal acid exposure (if present) Symptom severity during oesophageal acid exposure (VAS) Oesophageal motility LOS-pressure Oesophageal contractility | — |
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the GORD symptom score improvement based on the RDQ Questionnaire score. | — |
Countries
The Netherlands
Outcome results
None listed