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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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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01231217 |
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Date of registration:
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27/10/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Green Tea in Crohn's Disease
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Scientific title:
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Date of first enrolment:
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October 2010 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01231217 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Anja Hanemann, MS |
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Address:
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Telephone:
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00496221568701 |
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Email:
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anja.hanemann@med.uni-heidelberg.de |
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Affiliation:
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Name:
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Anja Hanemann, MS |
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Address:
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Telephone:
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00496221568701 |
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Email:
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anja.hanemann@med.uni-heidelberg.de |
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Affiliation:
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Name:
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Max Karner, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Heidelberg |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women and men = 18 years with signed informed consent,
- Patients with proven Crohn's disease,
- Chronic-active course = 3 months,
- Current CDAI = 150 and = 350,
- All medications for Crohn's disease have to be on a constant dosage for at least 4
weeks prior to study entry (i.e. 5-ASA, steroids),
- Ability of the participant to understand character and individual consequences of the
study.
Exclusion Criteria:
- Pregnancy or the wish to become pregnant, breastfeeding,
- Concomitant treatment with methotrexate, azathioprine or 6-mercaptopurine for < 3
months,
- Treatment with TNF-alpha-antagonists, cyclosporine or tacrolimus < 4 weeks prior to
study entry,
- Participation in another study within the last 4 weeks,
- Ulcerative colitis or indeterminate colitis,
- Infectious colitis, including cytomegalovirus or Clostridium difficile induced
colitis,
- Colitis for other reasons like known diverticulitis, radiation colitis, ischemic
colitis or microscopic colitis,
- Malabsorption syndromes, lactose intolerance, celiac disease, exocrine pancreas
insufficiency,
- Bleeding hemorrhoids,
- Other inflammatory or bleeding disorders of the colon and intestine, or diseases that
may cause diarrhea or gastrointestinal bleeding,
- Intolerance / aversion to tea and/or coffee,
- Current treatment with antibiotics.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Other: Green tea (Camellia sinensis)
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Other: Coffee
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Primary Outcome(s)
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Crohn's Disease Activity Index
[Time Frame: week 16]
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Secondary Outcome(s)
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Harvey-Bradshaw-Index
[Time Frame: week 16]
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Inflammatory Bowel Disease Questionnaire
[Time Frame: week 16]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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