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
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
-
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.