Mastiha or Mastiha Water in Functional Dyspepsia

NCT ID: NCT05687539

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-09-30

Brief Summary

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

Detailed Description

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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

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Functional Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mastiha water

Patients will receive 10ml of Mastiha water before every meal for one month

Group Type EXPERIMENTAL

Mastiha water

Intervention Type DIETARY_SUPPLEMENT

10ml of mastiha water before every meal for one month

Mastiha capsules

Patients will receive 2 Mastiha capsules (2x350mg) before every meal for one month

Group Type EXPERIMENTAL

Mastiha capsules

Intervention Type DIETARY_SUPPLEMENT

2x350mg mastiha capsules before every meal for one month

Control-Mastiha free

Patients will follow a Mastiha free one month period

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mastiha water

10ml of mastiha water before every meal for one month

Intervention Type DIETARY_SUPPLEMENT

Mastiha capsules

2x350mg mastiha capsules before every meal for one month

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harokopio University

OTHER

Sponsor Role lead

Responsible Party

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Andriana C. Kaliora

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andriana C. Kaliora, Ass. Prof.

Role: STUDY_DIRECTOR

Harokopio University

Locations

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Andriana Kaliora

Athens, , Greece

Site Status

Countries

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Greece

Other Identifiers

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MASTIHA-WATER-FD

Identifier Type: -

Identifier Source: org_study_id

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