Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis
NCT ID: NCT00718094
Last Updated: 2017-12-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2008-03-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Polyphenon E treatment
Polyphenon E® therapy was given for 56 days.
Polyphenon E®
Oral capsules
Placebo
Oral Placebo
Placebo Oral Tablet
Oral tablet: placebo
Interventions
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Polyphenon E®
Oral capsules
Placebo Oral Tablet
Oral tablet: placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Evidence of infectious colitis
* Labs outside of range
* Pregnancy or lactation
18 Years
85 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Louisville
OTHER
Responsible Party
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Gerald W. Dryden, Jr.
Principal investigator
Principal Investigators
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Gerald W Dryden, MD, MSPH
Role: PRINCIPAL_INVESTIGATOR
University of Louisville
Locations
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University of Louisville Clinical Research Center
Louisville, Kentucky, United States
Countries
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References
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Dryden GW, Lam A, Beatty K, Qazzaz HH, McClain CJ. A pilot study to evaluate the safety and efficacy of an oral dose of (-)-epigallocatechin-3-gallate-rich polyphenon E in patients with mild to moderate ulcerative colitis. Inflamm Bowel Dis. 2013 Aug;19(9):1904-12. doi: 10.1097/MIB.0b013e31828f5198.
Other Identifiers
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390.05
Identifier Type: -
Identifier Source: org_study_id
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