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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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12 December 2020 |
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Main ID: |
NCT04029649 |
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Date of registration:
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17/07/2019 |
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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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Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Ulcerative Colitis
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Scientific title:
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The Role of Beta-1,3/1,6-D-Glucan From Mycelium Extract of Indonesian Ganoderma Lucidum on Ulcerative Colitis: A Double-Blind Randomized Controlled Trial |
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Date of first enrolment:
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August 2019 |
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Target sample size:
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204 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04029649 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Marcellus Simadibrata |
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Address:
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Telephone:
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Email:
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Affiliation:
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Division Of Gastroenterology Department Of Internal Medicine Faculty Of Medicine Universitas Indonesia |
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Name:
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Marcellus Simadibrata |
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Address:
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Telephone:
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0816920448 |
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Email:
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marcellussimadibrata57@gmail.com |
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Affiliation:
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Name:
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Marcellus Simadibrata |
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Address:
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Telephone:
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0816920448 |
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Email:
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marcellussimadibrata57@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age =18 years old
- ulcerative colitis patients who are treated by 5-aminosalicylic acid (5-ASA) 3x500 mg
- agreed to participate in this study
Exclusion Criteria:
- ulcerative colitis patients who are treated by corticosteroid, immunosuppressive
agents and biologic agents
- allergic to Ganoderma lucidum
- could not be randomised and participate in this study by clinical judgement
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: Beta-1,3/1,6-D-Glucan
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Drug: Placebo
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Primary Outcome(s)
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Change in Quality of Life: SF-36 questionnaire
[Time Frame: 0 and 90 days]
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Secondary Outcome(s)
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Change of Interleukin 6 (IL-6) level
[Time Frame: 0 and 90 days]
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Change of Tumor Necrosis Factor Alpha (TNF-a) level
[Time Frame: 0 and 90 days]
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Number of patients with neutrophils infiltrating crypt epithelium in colon biopsy
[Time Frame: 0 and 90 days]
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Change of fecal calprotectin level
[Time Frame: 0 and 90 days]
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Change of Erythrocyte Sedimentation Rate (ESR)
[Time Frame: 0 and 90 days]
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Change of Mayo score
[Time Frame: 0 and 90 days]
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Change of C-Reactive Protein (CRP) level
[Time Frame: 0 and 90 days]
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Secondary ID(s)
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19-01-0083
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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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