Mastiha or Mastiha Water in Functional Dyspepsia

Not Applicable

Completed

• Conditions: Functional Dyspepsia
• Interventions: Dietary Supplement: Mastiha water; Dietary Supplement: Mastiha capsules

• Registration Number: NCT05687539
• Lead Sponsor: Harokopio University

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.

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2023-01-13
• Study First Posted: 2023-01-18
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mastiha water	Mastiha water	Patients will receive 10ml of Mastiha water before every meal for one month
Mastiha capsules	Mastiha capsules	Patients will receive 2 Mastiha capsules (2x350mg) before every meal for one month

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Andriana Kaliora; 🇬🇷 Athens, Greece