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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN51942129 |
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Date of registration:
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30/04/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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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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Date of first enrolment:
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01/05/2007 |
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Target sample size:
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140 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN51942129 |
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Study type:
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Interventional |
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Study design:
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Prospective randomised double blind placebo controlled trial (Quality of life)
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Phase:
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Countries of recruitment
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Greece
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Contacts
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Name:
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Konstantinos
Dabos |
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Address:
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Demokratias 5
821-00
Chios
Greece |
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Telephone:
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+30 2271 028 729 |
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Email:
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kostasophia@yahoo.com |
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Affiliation:
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Name:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Rome II criteria for functional dyspepsia
2. Negative Helicobacter pylori status
3. Negative gastroduodenoscopy
Exclusion criteria: 1. Primarily symptoms of Gastro-Oesaphageal Reflux Disease (GORD)
2. On prokinetic drugs
3. Suffering from Gastrointestinal (GI) malignancy
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Functional dyspepsia
Digestive System
Diseases of oesophagus, stomach and duodenum
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Intervention(s)
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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(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(s)
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Individual symptom changes, measured once, at the end of treatment.
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Secondary ID(s)
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MGCGH0031
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Source(s) of Monetary Support
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Mastic Gum Producers Cooperative (Greece)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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