NCT05687539

Mastiha or Mastiha Water in Functional Dyspepsia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Harokopio University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Mastiha water	10ml of mastiha water before every meal for one month
DIETARY_SUPPLEMENT	Mastiha capsules	2x350mg mastiha capsules before every meal for one month

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2023-01-18
• Last updated: 2025-01-27

Locations

1 site across 1 country: Greece