Functional Dyspepsia
Conditions
Brief summary
The main aim of this study is to establish whether Mastiha products ameliorate functional dyspepsia symptoms.
Detailed description
Functional dyspepsia has an approximate prevalence of 20% and is one of the main causes of upper abdominal discomfort. Its pathogenesis remain unclear and therapeutic options remain limited with patients seeking alternative therapies in herbal remedies. Mastiha has been proven to significantly improve symptoms in patients with functional dyspepsia compared to placebo. In the present study, the investigators aim to determine whether Mastiha capsules or Mastiha water have a better effect on the improvement of functional dyspepsia symptoms. Therefore, the investigators designed a randomized, three-way cross-over clinical trial. Fifty patients with functional dyspepsia, will be randomized over three treatment sequences of 30 days each, separated by 14-day washout periods. The three treatments will be: Mastiha capsules, Mastiha water or Mastiha free treatment. The primary outcome, which will be assessed by intention to treat, will be the Leuven Postprandial Distress Scale, a validated instrument for the assessment of symptoms in functional dyspepsia, supported by the European Medicines Agency.
Interventions
DIETARY_SUPPLEMENTMastiha water
10ml of mastiha water before every meal for one month
DIETARY_SUPPLEMENTMastiha capsules
2x350mg mastiha capsules before every meal for one month
Sponsors
Harokopio University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
functional dyspepsia diagnosis according to * Rome criteria * negative urea breath test for Helicobacter pylori * upper gastrointestinal tract endoscopy with biopsy
Exclusion criteria
* organic diseases, such as peptic ulcer, gastrointestinal neoplasms, gastroesophageal reflux, irritable bowel syndrome * pregnancy or lactation * history of abdominal surgery or actinotherapy * mental illness * Severe impairment of heart, liver, or kidney function or respiratory function * Alcohol overuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Leuven Postprandial Distress Scale (LPDS) | 1 month | The change in Leuven Postprandial Distress Scale will be evaluated at follow-up. LPDS minimum score is 0 and maximum 32. Higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life | 1 month | Change in quality of life at follow-up as assessed via the EQ-5D-5L questionnaire. EQ-5D-5L has a scale from 0 to 100, with higher scores meaning better outcomes. |
| Use of medicines | 1 month | The percentage of patients that changed drug dose of medicines for functional dyspepsia will be evaluated at follow-up. |
| Change in anxiety | 1 month | Change in anxiety at follow-up as assessed via the GAD-7 ANXIETY questionnaire. GAD-7 ANXIETY has a scale from 0 to 21, with higher scores meaning worse outcomes. |
Countries
Greece
Outcome results
None listed