Functional DyspepsiaNCT05687539
Mastiha or Mastiha Water in Functional Dyspepsia
A study testing Mastiha water and Mastiha capsules in people with Functional Dyspepsia, run by Harokopio University at 1 site in Greece.
Trial summary
The main aim of this study is to establish whether Mastiha products ameliorate functional dyspepsia symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Mastiha water and Mastiha capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jun 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- functional dyspepsia diagnosis according to
- Rome criteria
- negative urea breath test for Helicobacter pylori
- upper gastrointestinal tract endoscopy with biopsy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mastiha Products on Functional Dyspepsia. A Randomised Crossover Study.
The main aim of this study is to establish whether Mastiha products ameliorate functional dyspepsia symptoms.
Read the 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
- Being tested
- Mastiha water, Mastiha capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mastiha waterDietary supplement
10ml of mastiha water before every meal for one month
Mastiha capsulesDietary supplement
2x350mg mastiha capsules before every meal for one month
| Study group | Role | What they receive |
|---|---|---|
| Mastiha water | Experimental | Patients will receive 10ml of Mastiha water before every meal for one month Receives: Dietary Supplement: Mastiha water |
| Mastiha capsules | Experimental | Patients will receive 2 Mastiha capsules (2x350mg) before every meal for one month Receives: Dietary Supplement: Mastiha capsules |
| Control-Mastiha free | No intervention | Patients will follow a Mastiha free one month period |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (3)
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.
Measured: 1 month
Use of medicines
The percentage of patients that changed drug dose of medicines for functional dyspepsia will be evaluated at follow-up.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Jun 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andriana C. Kaliora, Harokopio University
- Investigators
- Andriana C. Kaliora, Ass. Prof., Study director, Harokopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687539
- Sponsor's protocol ID
- MASTIHA-WATER-FD
- Status last verified
- Jan 2025
- First submitted
- 28 Nov 2022
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41197785
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mastiha Products on Functional Dyspepsia. A Randomised Crossover Study.
- ClinicalTrials.gov ID
- NCT05687539
- Acronym / sponsor ID
- MASTIHA-WATER-FD
- Conditions
- Functional Dyspepsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mastiha water | Experimental | Dietary Supplement: Mastiha waterPatients will receive 10ml of Mastiha water before every meal for one month |
| Mastiha capsules | Experimental | Dietary Supplement: Mastiha capsulesPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- functional dyspepsia diagnosis according to
- Rome criteria
- negative urea breath test for Helicobacter pylori
- upper gastrointestinal tract endoscopy with biopsy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mastiha water10ml of mastiha water before every meal for one month | Dietary supplement | Mastiha water |
| Mastiha capsules2x350mg mastiha capsules before every meal for one month | Dietary supplement | Mastiha capsules |
Primary outcome
Changes in Leuven Postprandial Distress Scale (LPDS)
Time frame: 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.
3 secondary outcomes
Change in quality of life
Time frame: 1 month
Use of medicines
Time frame: 1 month
Change in anxiety
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Derived from this study: PubMed 41197785Kleftaki 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andriana C. Kaliora, Ass. Prof. study director
Harokopio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mastiha water and Mastiha capsules in people with Functional Dyspepsia, run by Harokopio University at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Leuven Postprandial Distress Scale (LPDS) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05687539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.