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The main aim of this study is to establish whether Mastiha products ameliorate functional dyspepsia symptoms.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mastiha water | Experimental | Patients will receive 10ml of Mastiha water before every meal for one month |
|
| Mastiha capsules | Experimental | Patients will receive 2 Mastiha capsules (2x350mg) before every meal for one month |
|
| Control-Mastiha free | No Intervention | Patients will follow a Mastiha free one month period |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mastiha water | Dietary Supplement | 10ml of mastiha water before every meal for one month |
| |
| 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 |
| 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 |
| Use of medicines |
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Inclusion Criteria:
functional dyspepsia diagnosis according to
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andriana C. Kaliora, Ass. Prof. | Harokopio University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andriana Kaliora | Athens | 17671 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41197785 | Derived | Kleftaki SA, Amerikanou C, Tzavara C, Biagki T, Sigala D, Bouziou A, Zouboulaki S, Koutsia A, Smyrnioudis EV, Anapliotis P, Kaliora AC. A randomized, three-way crossover clinical trial on the efficacy of Mastiha based therapies (Pistacia lentiscus var. Chia) in functional dyspepsia. Pharmacol Res. 2025 Dec;222:108019. doi: 10.1016/j.phrs.2025.108019. Epub 2025 Nov 4. |
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| ID | Term |
|---|---|
| C000718667 | mastiha |
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| Mastiha capsules |
| Dietary Supplement |
2x350mg mastiha capsules before every meal for one month |
|
The percentage of patients that changed 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 |