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ISRCTN
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ISRCTN51942129
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ClinicalTrials.gov identifier
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Public title
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Evaluation of Effectiveness of Mastic Gum in Functional Dyspepsia
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Scientific title
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Acronym
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EEMGFD
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Serial number at source
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MGCGH0031
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Study hypothesis
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Mastic gum improves symptoms in functional dyspepsia.
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Ethics approval
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Approval received from the North Aegean scientific research committee in October 2006 (ref: 165/06).
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Study design
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Prospective randomised double blind placebo controlled trial
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Countries of recruitment
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Greece
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Disease/condition/study domain
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Functional dyspepsia
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Participants - inclusion criteria
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1. Rome II criteria for functional dyspepsia
2. Negative Helicobacter pylori status
3. Negative gastroduodenoscopy
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Participants - exclusion criteria
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1. Primarily symptoms of Gastro-Oesaphageal Reflux Disease (GORD)
2. On prokinetic drugs
3. Suffering from Gastrointestinal (GI) malignancy
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Anticipated start date
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01/05/2007
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Anticipated end date
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01/08/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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140
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Interventions
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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.
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Primary outcome measure(s)
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1. Total symptom score changes, measured once at the end of treatment.
2. Global assessment of symptoms, measured once at the end of treatment.
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Secondary outcome measure(s)
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Individual symptom changes, measured once, at the end of treatment.
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Sources of funding
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Mastic Gum Producers Cooperative (Greece)
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Trial website
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19961914
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Contact name
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Dr
Konstantinos
Dabos
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Address
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Demokratias 5
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City/town
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Chios
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Zip/Postcode
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821-00
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Country
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Greece
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Tel
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+30 2271 028 729
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Email
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kostasophia@yahoo.com
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Sponsor
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Mastic Gum Producers Cooperative (Greece)
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Address
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Konstantinou Monomahou 1
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City/town
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Chios
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Zip/Postcode
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821-00
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Country
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Greece
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Sponsor website:
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http://www.gummastic.gr
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Date applied
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18/04/2007
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Last edited
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09/02/2010
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Date ISRCTN assigned
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30/04/2007
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