Condition category
Digestive System
Date applied
18/04/2007
Date assigned
30/04/2007
Last edited
09/02/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Konstantinos Dabos

ORCID ID

Contact details

Demokratias 5
Chios
821-00
Greece
+30 2271 028 729
kostasophia@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MGCGH0031

Study information

Scientific title

Acronym

EEMGFD

Study hypothesis

Mastic gum improves symptoms in functional dyspepsia.

Ethics approval

Approval received from the North Aegean scientific research committee in October 2006 (ref: 165/06).

Study design

Prospective randomised double blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

Functional dyspepsia

Intervention

Patients will be given either pure mastic gum in capsule form containing 350 mg or placebo capsules, twice daily. Patients will have treatment for three weeks. For safety reasons there will be a follow up visit four weeks later.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Total symptom score changes, measured once at the end of treatment.
2. Global assessment of symptoms, measured once at the end of treatment.

Secondary outcome measures

Individual symptom changes, measured once, at the end of treatment.

Overall trial start date

01/05/2007

Overall trial end date

01/08/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Rome II criteria for functional dyspepsia
2. Negative Helicobacter pylori status
3. Negative gastroduodenoscopy

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

140

Participant exclusion criteria

1. Primarily symptoms of Gastro-Oesaphageal Reflux Disease (GORD)
2. On prokinetic drugs
3. Suffering from Gastrointestinal (GI) malignancy

Recruitment start date

01/05/2007

Recruitment end date

01/08/2008

Locations

Countries of recruitment

Greece

Trial participating centre

Demokratias 5
Chios
821-00
Greece

Sponsor information

Organisation

Mastic Gum Producers Cooperative (Greece)

Sponsor details

Konstantinou Monomahou 1
Chios
821-00
Greece

Sponsor type

Industry

Website

http://www.gummastic.gr

Funders

Funder type

Industry

Funder name

Mastic Gum Producers Cooperative (Greece)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19961914

Publication citations

  1. Results

    Dabos KJ, Sfika E, Vlatta LJ, Frantzi D, Amygdalos GI, Giannikopoulos G, Is Chios mastic gum effective in the treatment of functional dyspepsia? A prospective randomised double-blind placebo controlled trial., J Ethnopharmacol, 2010, 127, 2, 205-209, doi: 10.1016/j.jep.2009.11.021.

Additional files

Editorial Notes