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Evaluation of Effectiveness of Mastic Gum in Functional Dyspepsia
ISRCTN ISRCTN51942129
DOI 10.1186/ISRCTN51942129
ClinicalTrials.gov identifier
EudraCT number
Public title Evaluation of Effectiveness of Mastic Gum in Functional Dyspepsia
Scientific title
Acronym EEMGFD
Serial number at source MGCGH0031
Study hypothesis Mastic gum improves symptoms in functional dyspepsia.
Lay summary
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
Countries of recruitment Greece
Disease/condition/study domain Functional dyspepsia
Participants - inclusion criteria 1. Rome II criteria for functional dyspepsia
2. Negative Helicobacter pylori status
3. Negative gastroduodenoscopy
Participants - exclusion criteria 1. Primarily symptoms of Gastro-Oesaphageal Reflux Disease (GORD)
2. On prokinetic drugs
3. Suffering from Gastrointestinal (GI) malignancy
Anticipated start date 01/05/2007
Anticipated end date 01/08/2008
Status of trial Completed
Patient information material
Target number of participants 140
Interventions 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.
Primary outcome measure(s) 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 measure(s) Individual symptom changes, measured once, at the end of treatment.
Sources of funding Mastic Gum Producers Cooperative (Greece)
Trial website
Publications 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19961914
Contact name Dr  Konstantinos  Dabos
  Address Demokratias 5
  City/town Chios
  Zip/Postcode 821-00
  Country Greece
  Tel +30 2271 028 729
  Email kostasophia@yahoo.com
Sponsor Mastic Gum Producers Cooperative (Greece)
  Address Konstantinou Monomahou 1
  City/town Chios
  Zip/Postcode 821-00
  Country Greece
  Sponsor website: http://www.gummastic.gr
Date applied 18/04/2007
Last edited 09/02/2010
Date ISRCTN assigned 30/04/2007
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