Mastiha or Mastiha Water in Functional Dyspepsia
The Effect of Mastiha Products on Functional Dyspepsia. A Randomised Crossover Study.
1 other identifier
interventional
48
1 country
1
Brief Summary
The main aim of this study is to establish whether Mastiha products ameliorate functional dyspepsia symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2022
CompletedFirst Submitted
Initial submission to the registry
November 28, 2022
CompletedFirst Posted
Study publicly available on registry
January 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedJanuary 27, 2025
January 1, 2025
2.3 years
November 28, 2022
January 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change in quality of life
1 month
Use of medicines
1 month
Change in anxiety
1 month
Study Arms (3)
Mastiha water
EXPERIMENTALPatients will receive 10ml of Mastiha water before every meal for one month
Mastiha capsules
EXPERIMENTALPatients will receive 2 Mastiha capsules (2x350mg) before every meal for one month
Control-Mastiha free
NO INTERVENTIONPatients will follow a Mastiha free one month period
Interventions
2x350mg mastiha capsules before every meal for one month
Eligibility Criteria
You may qualify if:
- functional dyspepsia diagnosis according to
- Rome criteria
- negative urea breath test for Helicobacter pylori
- upper gastrointestinal tract endoscopy with biopsy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Andriana Kaliora
Athens, 17671, Greece
Related Publications (1)
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.
PMID: 41197785DERIVED
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Andriana C. Kaliora, Ass. Prof.
Harokopio University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 28, 2022
First Posted
January 18, 2023
Study Start
June 1, 2022
Primary Completion
September 30, 2024
Study Completion
September 30, 2024
Last Updated
January 27, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share