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Mastiha or Mastiha Water in Functional Dyspepsia

Primary Purpose

Functional Dyspepsia

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Mastiha water
Mastiha capsules
Sponsored by
Harokopio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Andriana KalioraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Mastiha water

Mastiha capsules

Control-Mastiha free

Arm Description

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

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

Patients will follow a Mastiha free one month period

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Sense of adequate relief
The percentage of patients with adequate relief of symptoms will be evaluated at follow-up.
Use of medicines
The percentage of patients that decreased drug dose of medicines for functional dyspepsia will be evaluated at follow-up.
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.

Full Information

First Posted
November 28, 2022
Last Updated
October 11, 2023
Sponsor
Harokopio University
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1. Study Identification

Unique Protocol Identification Number
NCT05687539
Brief Title
Mastiha or Mastiha Water in Functional Dyspepsia
Official Title
The Effect of Mastiha Products on Functional Dyspepsia. A Randomised Crossover Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harokopio University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mastiha water
Arm Type
Experimental
Arm Description
Patients will receive 10ml of Mastiha water before every meal for one month
Arm Title
Mastiha capsules
Arm Type
Experimental
Arm Description
Patients will receive 2 Mastiha capsules (2x350mg) before every meal for one month
Arm Title
Control-Mastiha free
Arm Type
No Intervention
Arm Description
Patients will follow a Mastiha free one month period
Intervention Type
Dietary Supplement
Intervention Name(s)
Mastiha water
Intervention Description
10ml of mastiha water before every meal for one month
Intervention Type
Dietary Supplement
Intervention Name(s)
Mastiha capsules
Intervention Description
2x350mg mastiha capsules before every meal for one month
Primary Outcome Measure Information:
Title
Changes in Leuven Postprandial Distress Scale (LPDS)
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Change in quality of life
Description
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.
Time Frame
1 month
Title
Sense of adequate relief
Description
The percentage of patients with adequate relief of symptoms will be evaluated at follow-up.
Time Frame
1 month
Title
Use of medicines
Description
The percentage of patients that decreased drug dose of medicines for functional dyspepsia will be evaluated at follow-up.
Time Frame
1 month
Title
Change in anxiety
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andriana Kaliora, Ass. Prof.
Phone
00302109549226
Email
akaliora@hua.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andriana C. Kaliora, Ass. Prof.
Organizational Affiliation
Harokopio University
Official's Role
Study Director
Facility Information:
Facility Name
Andriana Kaliora
City
Athens
ZIP/Postal Code
17671
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andriana C Kaliora, Ass. Prof
Phone
+30 2109549226
Email
akaliora@hua.gr
First Name & Middle Initial & Last Name & Degree
Andriana C Kaliora, Ass. Prof

12. IPD Sharing Statement

Plan to Share IPD
No

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Mastiha or Mastiha Water in Functional Dyspepsia

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