Mastiha or Mastiha Water in Functional Dyspepsia

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05687539
• Other study ID #: MASTIHA-WATER-FD
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: October 30, 2025

Study information

• Verified date: April 2024
• Source: Harokopio University
• Contact: Andriana Kaliora, Ass. Prof.
• Phone: 00302109549226
• Email: akaliora[@]hua.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Intervention

Dietary Supplement:
• Mastiha water
10ml of mastiha water before every meal for one month
• Mastiha capsules
2x350mg mastiha capsules before every meal for one month

Locations

Country	Name	City	State
Greece	Andriana Kaliora	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Harokopio University

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Sense of adequate relief	The percentage of patients with adequate relief of symptoms will be evaluated at follow-up.	1 month
Secondary	Use of medicines	The percentage of patients that decreased drug dose of medicines for functional dyspepsia will be evaluated at follow-up.	1 month
Secondary	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