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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT01496053 |
Date of registration:
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15/12/2011 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD)
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Scientific title:
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Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective Study |
Date of first enrolment:
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December 2011 |
Target sample size:
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100 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01496053 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Norway
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Contacts
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Name:
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Egil Johnson, MD. Phd |
Address:
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Telephone:
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Email:
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Affiliation:
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Ullevaal University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- moderate disease
Exclusion Criteria:
- serious disease,
- biological treatment,
- pregnancy.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Crohn's Disease
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Inflammatory Bowel Disease
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Intervention(s)
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Dietary Supplement: Sugar Extract
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Dietary Supplement: AndoSan
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Primary Outcome(s)
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Reduction in biochemical blood parameters (pro-inflammatory cytokines)
[Time Frame: 21 days]
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Secondary Outcome(s)
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Clinical symptom score.
[Time Frame: 21 days]
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Reduction of calprotectin in feces.
[Time Frame: 21 days]
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Secondary ID(s)
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AbM2012-IBD
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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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