Mastiha or Mastiha Water in Functional Dyspepsia

Sponsor

Harokopio University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05687539

Collaborator

(none)

Enrollment

Location

Arms

29.5

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Functional Dyspepsia	Dietary Supplement: Mastiha water Dietary Supplement: Mastiha capsules	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 27, 2021

Anticipated Primary Completion Date :

Jul 27, 2023

Anticipated Study Completion Date :

Oct 13, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mastiha water Patients will receive 10ml of Mastiha water before every meal for one month	Dietary Supplement: Mastiha water 10ml of mastiha water before every meal for one month
Experimental: Mastiha capsules Patients will receive 2 Mastiha capsules (2x350mg) before every meal for one month	Dietary Supplement: Mastiha capsules 2x350mg mastiha capsules before every meal for one month
No Intervention: Control-Mastiha free Patients will follow a Mastiha free one month period

Arm

Intervention/Treatment

Experimental: Mastiha water

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

Dietary Supplement: Mastiha water

10ml of mastiha water before every meal for one month

Experimental: Mastiha capsules

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

Dietary Supplement: Mastiha capsules

2x350mg mastiha capsules before every meal for one month

No Intervention: Control-Mastiha free

Patients will follow a Mastiha free one month period

Outcome Measures

Primary Outcome Measures

Changes in Leuven Postprandial Distress Scale (LPDS) [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.

Secondary Outcome Measures

Change in quality of life [1 month]
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 [1 month]
The percentage of patients with adequate relief of symptoms will be evaluated at follow-up.
Use of medicines [1 month]
The percentage of patients that decreased drug dose of medicines for functional dyspepsia will be evaluated at follow-up.
Change in anxiety [1 month]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Andriana Kaliora	Athens		Greece	17671

Sponsors and Collaborators

Harokopio University

Investigators

Study Director: Andriana C. Kaliora, Ass. Prof., Harokopio University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andriana C Kaliora, Associate Professor, Harokopio University

ClinicalTrials.gov Identifier:

NCT05687539

Other Study ID Numbers:

MASTIHA-WATER-551

First Posted:

Jan 18, 2023

Last Update Posted:

Jan 18, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dyspepsia

Study Results

No Results Posted as of Jan 18, 2023