Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2008-11-30
2010-11-30
Brief Summary
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The objective of the present study is to evaluate tha efficacy of dark chocolate in improving LES relaxation in achalasia patients.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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1
dark chocolate consumption during manometry and 2 weeks treatment with dark chocolate
dark chocolate
21 g/d of dark chocolate for 2 weeks (7 g. before each meal). 7 grams of dark chocolate at day 1 during manometry.
2
placebo comparator: 7 grams of placebo-chocolate at day 1 during manometry, and than crossover to treatment with dark chocolate for 2 weeks.
placebo chocolate with crossover to dark chocolate
Placebo at day 1 during manometry, and than crossover to dark chocolate for 2 weeks treatment.
Interventions
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dark chocolate
21 g/d of dark chocolate for 2 weeks (7 g. before each meal). 7 grams of dark chocolate at day 1 during manometry.
placebo chocolate with crossover to dark chocolate
Placebo at day 1 during manometry, and than crossover to dark chocolate for 2 weeks treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* "Achalasia" diagnosis during manometry at day 1 of the study.
Exclusion Criteria
* pseudoachalasia
* consumption of GI-motility modifiers durin 72 hours preceding the study.
18 Years
ALL
No
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Tel-Aviv Sourasky Medical Center
Other Identifiers
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achalasia1
Identifier Type: -
Identifier Source: secondary_id
TASMC-08-GR-370-CTIL
Identifier Type: -
Identifier Source: org_study_id