Mastiha or Mastiha Water in Functional Dyspepsia

Study Overview
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Brief Summary
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The main aim of this study is to establish whether Mastiha products ameliorate functional dyspepsia symptoms.

Detailed Description
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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.

Official Title
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The Effect of Mastiha Products on Functional Dyspepsia. A Randomised Crossover Study.

Conditions
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Functional Dyspepsia

Intervention / Treatment
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* Dietary Supplement: Mastiha water
* Dietary Supplement: Mastiha capsules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mastiha water<br>Patients will receive 10ml of Mastiha water before every meal for one month | Dietary Supplement: Mastiha water<br>* 10ml of mastiha water before every meal for one month<br>|
| Experimental: Mastiha capsules<br>Patients will receive 2 Mastiha capsules (2x350mg) before every meal for one month | Dietary Supplement: Mastiha capsules<br>* 2x350mg mastiha capsules before every meal for one month<br>|
| No Intervention: Control-Mastiha free<br>Patients will follow a Mastiha free one month period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Leuven Postprandial Distress Scale (LPDS) | 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. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | 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. | 1 month | 
| Sense of adequate relief | The percentage of patients with adequate relief of symptoms will be evaluated at follow-up. | 1 month | 
| Use of medicines | The percentage of patients that decreased drug dose of medicines for functional dyspepsia will be evaluated at follow-up. | 1 month | 
| Change in anxiety | 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. | 1 month |